If any of the securities being registered on this form are to be offered on a delayed or continuous basis
pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the
following box.
[X]
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the
Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the
same offering.
[ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check
the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check
the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [
]
If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box.
[ ]
CALCULATION OF REGISTRATION FEE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Title of each
class of securities
to be registered
|
|
|
Amount to be
registered
|
|
|
|
Proposed maximum
offering price
per share
(1)
|
|
|
|
Proposed maximum
aggregate offering
price
|
|
|
|
Amount of
registration fee
|
|
Common Stock, $0.0001 par value
|
|
|
2,776,052
|
|
|
$
|
2.00
|
|
|
$
|
5,552,104
|
|
|
$
|
715.11
|
|
Shares of Common Stock underlying Series A Warrants
|
|
|
1,995,601
|
|
|
$
|
2.05
|
|
|
$
|
4,090,982
|
|
|
$
|
526.92
|
|
Shares of Common Stock underlying Series A Warrants
|
|
|
1,995,601
|
|
|
$
|
3.08
|
|
|
$
|
6,146,451
|
|
|
$
|
791.66
|
|
Total Registration Statement Fee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,033.69
|
|
______________
(1)
Estimated solely for the purpose of calculating the registration fee in accordance
with Rule 457(e) under the Securities Act of 1933.
The registrant hereby amends this registration statement on such date or dates as may be
necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall
thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such
date as the Commission, acting pursuant to said Section 8(a), may determine.
Neither the Securities Exchange Commission nor any state securities commissions have
approved or disapproved of these securities or passed upon the adequacy of the Prospectus. Any representation to the contrary is a criminal offense.
Filed Pursuant to Rule 424(b)(3)
Registration No. ______________
Dated May __, 2014
VYCOR MEDICAL, INC.
6,767,254 Shares of Common Stock
Par Value $0.0001 Per Share
This prospectus relates to the offering by the selling stockholders of
VYCOR MEDICAL
,
INC. of up to 6,767,254 shares of our common stock, par value $0.0001 per share. We will not receive any proceeds from the sale of common stock.
The selling stockholders have advised us that they will sell the shares of common stock from
time to time in brokers transactions, in the open market, on the OTC Bulletin Board, in privately negotiated transactions or a combination of these
methods, at market prices prevailing at the time of sale, at prices related to the prevailing market prices or at negotiated prices. We will pay the
expenses incurred to register the shares for resale, but the selling stockholders will pay any underwriting discounts, commissions or agents
commissions related to the sale of their shares of common stock.
Our common stock is traded on the OTC Bulletin Board under the symbol
VYCO.OB. On May 27, 2014, the closing sale price of our common stock was $2.15
per share.
You should rely only on the information contained in this prospectus or any prospectus
supplement or amendment. We have not authorized anyone to provide you with different information.
Investing in these securities involves significant risks. See Risk
Factors beginning on page 12
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of the securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a
criminal offense.
The date of this prospectus is May __, 2014.
The information contained in this prospectus is not complete and may be
changed. This prospectus is included in the registration statement that was filed by VYCOR MEDICAL, INC. with the Securities and Exchange
Commission. The selling stockholders may not sell these securities until the registration statement becomes effective. This prospectus is
not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
TABLE OF CONTENTS
|
|
PAGE
|
SUMMARY INFORMATION AND RISK FACTORS
|
|
1
|
USE OF PROCEEDS
|
|
19
|
DETERMINATION OF OFFERING PRICE
|
|
19
|
DILUTION
|
|
19
|
SELLING STOCKHOLDERS
|
|
19
|
PLAN OF DISTRIBUTION
|
|
23
|
DESCRIPTION OF SECURITIES TO BE REGISTERED
|
|
24
|
INTEREST OF NAMED COUNSEL AND EXPERT
|
|
29
|
INFORMATION WITH RESPECT TO THE REGISTRANT
|
|
29
|
LEGAL PROCEEDINGS
|
|
37
|
DESCRIPTION OF PROPERTY
|
|
37
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
38
|
CHANGES AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
|
43
|
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
|
|
44
|
EXECUTIVE COMPENSATION
|
|
47
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
|
|
49
|
TRANSACTIONS WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS AND DIRECTOR INDEPENDENCE
|
|
50
|
EXPERTS
|
|
51
|
WHERE YOU CAN FIND ADDITIONAL INFORMATION
|
|
51
|
INCORPORATION OF CERTAIN MATERIAL BY REFERENCE
|
|
51
|
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
|
|
51
|
FINANCIAL STATEMENTS
|
|
52
|
SUMMARY INFORMATION AND RISK FACTORS
The items in the following summary are described in more detail later in this
prospectus. This summary provides an overview of selected information and does not contain all the information you should consider before investing
in the securities. Before making an investment decision, you should read the entire prospectus carefully, including the Risk Factors
section, the financial statements, and the notes to the financial statements.
For purposes of this prospectus, unless otherwise indicated or the context otherwise
requires, all references herein to Vycor, the Company, we, us, and our, refer to VYCOR MEDICAL,
INC., a Delaware corporation.
SUMMARY OF THE COMPANY
ORGANIZATIONAL HISTORY
The Company was formed as a limited liability company under the laws of the State of New York on
June 17, 2005 as Vycor Medical LLC. On August 14, 2007, we converted into a Delaware corporation and changed our name to Vycor Medical,
Inc.. The Companys listing went effective on February 2009 and on November 29, 2010 Vycor completed the acquisition of substantially all of the
assets of NovaVision, Inc. (NovaVision) and on January 4, 2012 Vycor, through its wholly-owned NovaVision subsidiary, completed the acquisition of
all the shares of Sight Science Limited (Sight Science), a previous competitor to NovaVision.
BUSINESS OVERVIEW
Vycor is dedicated to providing the medical community with innovative and superior neurosurgical
and neurotherapeutic solutions and operates two distinct business units within the medical industry. Vycor Medical designs, develops and markets medical devices
for use in neurosurgery. NovaVision develops non-invasive, computer-based light stimulation therapies for those suffering from vision loss resulting from
neurological trauma.
Both businesses adopt a minimally or non-invasive approach. Both technologies have strong sales
growth potential, address large potential markets and have the requisite regulatory approvals. The Company has 40 granted patents and a further 15 pending. The
Company leverages joint resources across the divisions to operate in a cost-efficient manner
.
In addition to our existing products and products in development we actively seek acquisition,
joint venture and in-licensing opportunities in the medical device field which we believe are complementary, can benefit from our existing infrastructure and
will add shareholder value.
Vycor Medical
Vycor Medical manufactures and distributes the ViewSite Brain Access System (VBAS), a clear
cylindrical disposable set of single-use devices of different sizes, which neurosurgeons use to provide a surgical corridor to access and remove target sites
within the brain such as tumors. VBAS provides a minimally invasive approach into the brain, with potentially less damage to the surrounding tissue than the
sharp edges of traditional blade retractors. It is this minimally invasive profile that has led surgeons to use the VBAS in challenging procedures
and procedures that were previously considered to be inoperable such as tumors that are too deeply seated for current instruments.
VBAS clinical advantages are supported by a number of leading peer-reviewed articles.
Clinical benefits cited include: minimally invasive shape and less invasive procedure; resultant reduction of pressure on the brain; improved visual field;
improved working channel; and more accurate target access. Management also believes, from anecdotal surgeon feedback, that although a disposable product VBAS
offers potential cost savings from shorter operating theater time and reduced post-operative recovery time.
Vycor Medical is ISO 13485 compliant, VBAS has U.S. FDA 510(k) clearance for brain and spine
surgeries and full regulatory approvals for brain in Australia, Canada, China, Europe (EU Class III), Korea and Japan and is seeking or has partial
regulatory approvals in Brazil, India, Russia, Taiwan and Vietnam. VBAS has 8 granted and 8 pending patents worldwide
NovaVision
NovaVision provides non-invasive, computer-based vision solutions targeted at a substantial and
largely un-addressed market of people who have lost their sight as a result of Stroke or Traumatic Brain Injury (neurological brain damage).
1
NovaVision addresses a significant target market, estimated at approximately $2 billion in the
U.S. and over $13 billion globally.
NovaVision has a family of therapies that both restore lost vision and address other
neurologically-induced vision issues. NovaVisions Vision Restoration Therapy (VRT) and Sight Sciences Neuro-Eye Therapy (NeET) are restitution or
restoration therapies that are designed to improve visual sensitivity in the previously blind zones; NovaVision’s NeuroEyeCoach™ is a compensation
therapy which complements VRT and NeET and re-trains the ability of a patient to move their eyes, re-integrate left and right vision and to make the most of
their remaining visual field.
Vycor acquired NovaVision at the end of 2010. While its VRT was clinically supported to be
effective, was underpinned by 15 years of clinical research and 20 studies evidencing that 70% of patients benefited from the therapy, further development was
required in order: to ensure that all patients received benefit; to make it cost effective and affordable; and to make it scalable. As not all patients benefit
from VRT, management concluded that a new complementary eye training therapy should be introduced into the NovaVision therapy suite to provide broader benefits
to patients than the delivery of VRT on its own, and has recently soft-launched NeuroEyeCoach™ in the U.S.
NovaVision’s VRT is the only medical device aimed at the restoration of vision for
neurologically induced vision loss which has FDA 510(k) clearance to be marketed in the U.S; VRT and NeET both have CE Marking for the EU and
NeuroEyeCoach™ is registered as a Class I 510(k) exempt device. NovaVision has 32 granted and 7 pending patents worldwide.
Employees
We currently have 17 employees.
Websites
The Company operates websites at
www.vycormedical.com,
www.novavision.com, www.neuroeyecoach.com and www.sightscience.com
GROWTH STRATEGY
Vycor Medical
Vycor Medicals growth strategy is centered around:
1.
Increasing U.S. market penetration
through broader hospital coverage and targeted direct physician
marketing.
Vycor Medicals sales and marketing strategy is to penetrate a well defined target market
of 3,500 neurosurgeons by trade shows, significantly increased direct marketing with VBAS samples and existing clinical data, and through its existing
distributors which it is continually evaluating and upgrading as well as adding additional distributors in regions where it has little to no presence. In
marketing to these hospitals and surgeons, Vycor Medical leads with those neurosurgical procedures where VBAS competitive advantages are most easily
understood deep seated tumors and other complicated deep procedures. The focus is both on adding new hospitals and expanding to additional surgeons in
hospitals where VBAS is already approved and to expand usage to a broader range of procedures. Vycor Medical prioritizes its attention on teaching hospitals,
which not only carry out more relevant procedures but also provide a natural way to drive adoption through the conversion of new surgeons.
2.
Provision of more Clinical and Scientific Data
supporting the products superiority
over the current standard of care blade retractors and to demonstrate the products potential for cost savings.
Clinical and scientific data (in the form of peer reviewed articles, clinical studies and other
reports and case studies) are critical in driving adoption further and faster by demonstrating VBAS' superiority as a minimally invasive access system which
helps VBAS move further up the hospital cost/benefit curve. To this end an animal comparative study is currently underway. This study is intended to demonstrate
greater ease of access, faster surgery time and reduced tissue damage. The second area Vycor Medical will address is MRI compatibility. Increasingly, intra
operative MRI is increasingly being used in neurosurgery, further playing to VBAS' competitive edge over the traditional non MRI-compatible metal blade
retractor. Vycor Medical intends to commission a brief technical study so that VBAS can be
2
formally certified as MRI compatible. Vycor Medical is also aware of two additional studies in
peer-reviewed journals anticipated to be published during 2014 by the Weill Cornell Medical Center, and additional studies are also underway and should be
published during 2014 and 2015.
3.
International Market Growth
Vycor Medical utilizes select medical device distributors with experience in neurosurgical
devices in their countries or regions. In Europe, the Company currently only has a limited number of distributors and is only now turning its focus to this
geographic region. VBAS has full regulatory approvals in Australia, Canada, China, Europe (EU Class III), Korea and Japan and is seeking or has partial
regulatory approvals in Brazil, India, Russia, Taiwan and Vietnam. Vycor Medical plans on focusing on the international markets and is actively pursuing new
distribution agreements.
4
. New Product Development
New Product Development is targeted at both driving the use of its existing VBAS product range
through ancillaries that will facilitate the products use and through new product extensions to broaden VBAS applicability to procedures currently not
addressed by the existing product line.
Vycor Medical has launched in the US a universal non-disposable extension arm to VBAS, as a
result of surgeon feedback, which further increases the ease of use of its disposable VBAS product and, management believes, will augment VBAS adoption.
Vycor Medical has prototyped and is now implementing manufacturing of two new smaller VBAS
devices that will facilitate endoscopic work within the ventricles including the placement of catheters, with particular relevance for the pediatric
neurosurgical market. Vycor Medical developed this with a leading neurosurgeon and anticipates the product being available by the end of 2014.
Vycor Medical is also working on a new set of VBAS devices that will be targeted at being
completely compatible with selected Image Guided Systems. Management strongly believes that the existing VBAS rigid structure lends itself well to being
incorporated into the increasing trend of IGS surgery and anticipates having compatible devices finalized for production during 2014.
NovaVision
Prior to Vycors acquisition in late 2010, NovaVision previous management had already
invested more than $50 million largely on developing the businesss core VRT therapy, gaining significant patent protection and validating the therapy
through significant clinical research.
While its VRT was clinically supported to be effective, being underpinned by 15 years of clinical
research and 20 studies evidencing that 70% of patients benefited from the therapy, further development was required in order to: ensure that all patients
received a benefit; to make it cost effective and affordable; and to make it scalable.
Following the acquisition, Vycor put in place a world class Scientific Advisory Board and
acquired Sight Science in the UK, NovaVisions only sizeable competitor, thereby also gaining a highly regarded Chief Scientific Officer. Leveraging this
scientific team, NovaVisions strategy is centered around driving the adoption of its therapies, through:
1. Reduced Cost and Greater scalability;
enabled by a completely new therapy delivery
mechanism moving away from hardware based to an asset light software solution allowing significant cost savings, which will be passed onto the patients. This
different delivery mechanism and significant business process streamlining of currently largely manual tasks will enable NovaVision to provide an affordable and
much more scalable therapy and thus be in a position to service a much larger number of patients.
2. Introduction of a new therapy module
into the NovaVision’s overall visual
rehabilitation therapy regime that will provide additional functional benefits to patients who undergo the regime. This new therapy program,
NeuroEyeCoach™, is a saccadic training program which is highly complementary to VRT and will ensure that patients will receive greater benefit from the
overall NovaVision therapy regime. NeuroEyeCoach™ is internet-delivered and is targeted at the same patients as VRT. Stroke patients, in addition to
losing their sight, typically also have difficulty moving their eyes and integrating visual information. These conditions lead patients to need specific
re-training to make effective use of their eyes and get the most out of their remaining vision. NeuroEyeCoach™ will be
3
sold as a standalone therapy; in addition to benefitting VRT patients, those suffering
non-permanent defects or those otherwise unsuited to VRT can benefit from NeuroEyeCoach™. Upon completion of the VRT web based development it will be
marketed with NeuroEyeCoach™ in one therapy suite providing broader benefit to patients.
3. New Potential Licensing model targeted at Rehabilitation Centers
. Management is
also in the advanced stages of exploring a licensing model under which NovaVision would license a diagnostic-only VRT device to a rehabilitation center for a
monthly fee. The center, be it in-patient or out-patient, would be able to efficiently screen its patients on their own for visual field deficits. NovaVision
would receive licensing fees and benefit from incremental patient flow from center referrals.
4
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements. This prospectus includes statements
regarding our plans, goals, strategies, intent, beliefs or current expectations. These statements are expressed in good faith and based upon a reasonable basis
when made, but there can be no assurance that these expectations will be achieved or accomplished. These forward looking statements can be identified by the use
of terms and phrases such as believe, plan, intend, anticipate, target, estimate,
expect, and the like, and/or future-tense or conditional constructions may, could, should, etc. Items
contemplating or making assumptions about, actual or potential future sales, market size, collaborations, and business opportunities also constitute such
forward-looking statements.
Although forward-looking statements in this report reflect the good faith judgment of our
management, forward-looking statements are inherently subject to known and unknown risks, business, economic and other risks and uncertainties that may cause
actual results to be materially different from those discussed in these forward-looking statements. Readers are urged not to place undue reliance on these
forward-looking statements, which speak only as of the date of this report. We assume no obligation to update any forward-looking statements in order to reflect
any event or circumstance that may arise after the date of this report, other than as may be required by applicable law or regulation. Readers are urged to
carefully review and consider the various disclosures made by us in our reports filed with the Securities and Exchange Commission which attempt to advise
interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these
risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.
CORPORATE ADDRESS AND TELEPHONE NUMBER
The Company maintains its designated office at 6401 Congress Ave., Suite 140, Boca Raton, FL 33487. The Companys
telephone number is 561-558-2000.
THE OFFERING
This prospectus will be utilized in connection with the re-sale of 6,767,254 shares which
could be potentially issued in the future as of the result of the sale of common stock and the prospective exercise of certain investor warrants and placement
agent warrants which were issued in connection with the Companys recent stock offering. The Company will not receive any proceeds from any
sales of these shares.
|
|
|
|
|
Common stock currently outstanding
|
10,703,494 shares
(1)
|
|
|
|
|
Common stock offered by the selling stockholders
|
6,767,254 shares
|
|
|
|
|
Use of proceeds
|
We will not receive any proceeds from the sale of common stock offered by this prospectus.
|
|
|
|
|
__________________
(1)
Shares of common stock issued and outstanding as of May 23, 2014.
5
FINANCIAL INFORMATION
SELECTED CONSOLIDATED FINANCIAL DATA
The following selected consolidated statement of operations data contains consolidated
statement of operations data and consolidated balance sheet for the fiscal years period ended December 31, 2013, December 31, 2012 and December 31, 2011. The
consolidated statement of operations data and balance sheet data were derived from the audited consolidated financial statements. All share amounts are restated
to reflect a one-for-150 reverse stock split which became effective January 15, 2013. Such financial data should be read in conjunction with the
consolidated financial statements and the notes to the consolidated financial statements starting on page 45 and with Managements Discussion and
Analysis of Financial Condition and Results of Operations.
|
|
|
|
|
|
|
|
|
12/31/13
|
|
12/31/12
|
|
12/31/11
|
Revenues
|
|
$
|
1,089,374
|
|
|
$
|
1,205,263
|
|
|
$
|
971,367
|
|
Net comprehensive loss
|
|
$
|
(2,444,491
|
)
|
|
$
|
(2,926,210
|
)
|
|
$
|
(4,778,541
|
)
|
Net comprehensive loss per share (1)
|
|
$
|
(0.39
|
)
|
|
$
|
(0.52
|
)
|
|
$
|
(0.92
|
)
|
Weighted average no. shares (1)
|
|
|
6,324,175
|
|
|
|
5,637,690
|
|
|
|
5,200,645
|
|
Stockholders’ equity (deficit)
|
|
$
|
(3,315,243
|
)
|
|
$
|
(1,457,650
|
)
|
|
$
|
875,324
|
|
Total assets
|
|
$
|
2,115,250
|
|
|
$
|
2,561,161
|
|
|
$
|
3,571,640
|
|
Total liabilities
|
|
$
|
5,430,492
|
|
|
$
|
4,018,810
|
|
|
$
|
2,696,316
|
|
(1) Adjusted to reflect a one-for-150 reverse stock split which became effective January 15, 2013
The following selected data contains statement of operations data and balance sheet for the
three months ended March 31, 2014 and March 31, 2013. The statement of operations data and balance sheet data were derived from the financial statements for the
periods. Such financial data should be read in conjunction with the unaudited financial statements and the notes to the financial statements for said periods
starting on page 45 and with Managements Discussion and Analysis of Financial Condition and Results of Operations.
|
|
|
|
|
|
|
As of
March 31,
2014
|
|
As of
March 31,
2013
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
Assets
|
|
$
|
4,861,338
|
|
|
$
|
2,324,985
|
|
Liabilities
|
|
$
|
5,108,670
|
|
|
$
|
4,400,352
|
|
Total Stockholders’ Deficit
|
|
$
|
(247,332
|
)
|
|
$
|
(2,075,367
|
)
|
Statement of Operations Data
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
358,122
|
|
|
$
|
231,674
|
|
Operating Expenses
|
|
$
|
1,307,704
|
|
|
$
|
801,277
|
|
Net Comprehensive Loss
|
|
$
|
(788,010
|
)
|
|
$
|
(662,672
|
)
|
Basis and Diluted Loss Per Share (1)
|
|
$
|
(0.09
|
)
|
|
$
|
(0.11
|
)
|
Weighted Average Number of Shares
Outstanding (1)
|
|
|
8,995,082
|
|
|
|
5,947,998
|
|
(1) Adjusted to reflect a one-for-150 reverse stock split which became effective January 15, 2013
6
RISK FACTORS
Before you invest in our securities, you should be aware that there are various risks. You
should consider carefully these risk factors, together with all of the other information included in this annual report before you decide to purchase our
securities. If any of the following risks and uncertainties develop into actual events, our business, financial condition or results of operations could be
materially adversely affected.
Risks Related to Our Financials
We do not have a significant operating history and have not achieved profitable
operations. If we are unable to achieve profitable operations, you may lose your entire investment.
We have incurred losses since our inception, including a net loss of $2,444,491 for the year
ended December 31, 2013 and a net loss of $788,010 for the three months ended March 31, 2014 and we expect to incur additional losses, including additional
development costs, costs related to clinical studies and manufacturing expenses. We have incurred negative cash flows from operations since inception. As of
March 31, 2014 we had a stockholders deficit of $247,332 and a cash and cash equivalents balance of $2,707,089. Since we have no record of profitable
operations, there is high a possibility that you may suffer a complete loss of your investment.
The absence of significant operating history for us makes forecasting our revenue and
expenses difficult, and we may be unable to adjust our spending in a timely manner to compensate for unexpected revenue shortfalls or unexpected expenses.
As a result of the absence of profitable operating history for us, it
is difficult to accurately forecast our future revenue. In addition, we have limited meaningful historical financial data upon which to base planned operating
expenses. Current and future expense levels are based on our operating plans and estimates of future revenue. Revenue and operating results are difficult to
forecast because they generally depend on our ability to promote and sell our products and revenues can fluctuate due the timing impact of larger orders. As a
result, we may be unable to adjust our spending in a timely manner to compensate for any unexpected revenue shortfall, which would result in further losses. We
may also be unable to expand our operations in a timely manner to adequately meet demand to the extent it exceeds expectations.
Our limited operating history does not afford investors a
sufficient history on which to base an investment decision.
We were formed on June 17, 2005, Vycor Medicals products were
only fully launched at the beginning of 2010 and NovaVisions therapies were re-launched after acquisition in early 2011 but are not being aggressively
marketed until completion of the NovaVision development programs; we are therefore currently in the relatively early stages of marketing our products and
therapies. There can be no assurance at this time that we will ever operate profitably or that we will have adequate working capital to meet our obligations as
they become due. Investors must consider the risks and difficulties frequently encountered by early stage companies, particularly in rapidly evolving markets.
Such risks include the following:
|
|
|
competition;
|
|
need
for acceptance of products and therapies there can be no assured market for our products
and therapies and there is no guarantee of orders or of surgeon, physician or patient acceptance;
|
7
|
|
|
ability to continue to develop and extend brand identity;
|
|
ability to anticipate and adapt to a competitive market;
|
|
ability to effectively manage rapidly expanding operations;
|
|
amount and timing of operating costs and capital expenditures
relating to expansion of our business, operations, and infrastructure; and
|
|
dependence upon key personnel to market and sell our products
and the loss of one of our key managers may adversely affect the marketing of our products.
|
We cannot be certain that our business strategy will be successful or that we will
successfully address these risks. In the event that we do not successfully address these risks, our business, prospects, financial condition, and results of
operations could be materially and adversely affected.
Our revenue is dependent upon acceptance of our products and
therapies by the market. The failure of such acceptance will cause us to curtail or cease operations.
Our revenue comes from the sale of our products and therapies. As
a result, we will continue to incur operating losses until such time as sales of our products and therapies reach a mature level and we are able to generate
sufficient revenue from the sale of our products and therapies to meet our operating expenses. There can be no assurance that customers will adopt our
technology and products, or that businesses and prospective customers will agree to pay for our products and therapies. In the event that we are not able to
significantly increase the number of customers that purchase our products and therapies, or if we are unable to charge the necessary prices, our financial
condition and results of operations will be materially and adversely affected.
We will have a continuing need to raise substantial additional funds to
continue bring products to market and operate.
Our current funds may not be sufficient to bring the Company to a
cash flow positive position and implement our strategic development plan. We may also require additional funding to develop new products. As a
result, we may require additional funds in order to continue our operations after we exhaust our available funding.
There is no
assurance that additional funds will be available for the Company to finance its operations on acceptable terms, or at all. If adequate funds are not available,
the Company may have to delay development or commercialization of products or technologies that the Company would otherwise seek to commercialize, or cease
operations.
For a period of time we are contractually obligated not to issue additional shares, or share
equivalents, for cash at a share price below $2.05 per share, which may restrict our ability to raise additional funds, if required.
Effective May 15, 2014 the Company and the investors in the Companys $5,000,000
private placement completed on April 25, 2014 entered into waivers of the Share Purchase Agreements and Series A Warrant Agreements (the Waivers) under which the investors
agreed to waive their anti-dilution rights (which arose in the event the Company sold securities at a price below $2.05 within one year of the date that the
initial Registration Statement with respect to the securities sold in the offering has been declared effective by the SEC) in consideration of the Companys agreement not to sell any securities at a price
below $2.05 within the same one-year period. If the Company is required to raise additional funding during this period it will not be able to do so at a share
price (or equivalent share price) of less than $2.05 and this may restrict the Companys ability to raise funds if required.
8
The majority of the non-cash assets on our balance sheet comprise assets that are subject to annual
accounting impairment review and therefore may be subject to write-downs which will affect both the balance sheet and net profit or loss.
The non-cash assets on our balance sheet include patents, software,
and trademarks which are reviewed for impairment by the Company annually in accordance with the authorative guidance. Impairment is recognized when the
estimated undiscounted cash flows associated with the asset or group of assets is less than their carrying value. If impairment exists, an adjustment is made to
write the asset down to its fair value, and a loss is recorded as the difference between the carrying value and fair value. We will review these assets as part
of the preparation of the financial statements for 2014 and subsequent years and, if an impairment exists, would be required to recognize an impairment to some
Risks Related to Our Business
Our existing products and therapies may not be accepted in the marketplace.
Uncertainty exists as to whether our products and therapies will be
fully accepted by the market without additional clinical evaluations and more widespread doctor acceptance. A number of factors may limit the market acceptance
of our products and therapies, including the availability of alternative products and therapies and the price of our products and therapies relative to
alternative products and therapies.
There is a risk that surgeons will be encouraged to continue to use
multiple-use devices, such as standard blade retractors, instead of our single use devices. Our VBAS device is designed to be used only once and then discarded.
Vycor Medicals competitors market multiple use devices such as metal blade retractors. The multiple use devices are significantly less expensive on a per
use basis than our single use devices. We are assuming that, notwithstanding the difference in price, surgeons will elect to use our devices because of their
perception that our devices will permit safer and less invasive surgery. However, hospitals, medical insurance providers, health maintenance organizations and
others approving surgical costs may decide that the cost outweighs the benefit. In addition, surgeons may opt to use other devices. While Vycor Medical intends
to continue to build clinical and other scientific data demonstrating the cost benefit of VBAS over other methodologies, this data may not be conclusive or may
be viewed as insufficient by hospitals or physicians.
In the US, NovaVisions therapies require physician
prescriptions, and physicians may not be persuaded by the effectiveness of our therapies to prescribe them to their patients, given the current price compared
to the physician perception of the therapy benefit. Whilst NovaVision intends to continue to implement strategies to increase awareness of its therapies, and
their benefits, and reduce their cost to patients, there is no assurance that this strategy will be successful, particularly in that the target audience (for
both physicians and patients) is very large and diverse and the patient audience tends to be both medically and financially challenged, requiring multiple
methods and routes to access it. The marketing expenditures required to achieve the level of awareness may also be too high for the Company to address
successfully. NovaVisions VRT therapy usually takes 6 months to complete, requiring patients to carry out the therapy twice a day (for an hour total), 6
days a week. Patients have to be persuaded that this level of intense therapy is justified for the anticipated benefit, but there is no assurance that
sufficient numbers of patients will be convinced to enable a successful market to develop for the therapy.
Some of our competitors are more established and better
capitalized than we are and we may be unable to establish market share.
Some of our competitors are well known, more established and better
capitalized than we are. As such, they may have at their disposal greater marketing strength and economies of scale and, as they may have additional products
which they sell to the same customers, have greater presence with these customer. They may also have more resources to expend on research and development to
create more innovative products in competition with ours. Competition will also likely increase as or when the clinical and cost benefits of the Companys
products and therapies are established and proven. Accordingly, we may not be successful in competing with them for market share.
Sales may not produce profits.
We may be forced to sell our products and therapies at a lower price
than anticipated due to a variety of reasons, including without limitation selling prices of comparable products by our competitors and budget or financial
constraints of our customers. Further, we may sell fewer products or therapies than anticipated, and the costs associated with each unit, including costs of
manufacturing, delivery and commissions, may be greater than
9
anticipated. As a result, there is a risk that costs associated with the sales of our
products and therapies may be greater than we anticipated and that sales may fail to yield profitability.
International sales of our VBAS product tend to be more
lumpy in nature and less predictable. In addition, Vycor Medicals realized sales price for international sales tends to be lower than in the
US. This is because Vycor Medical always partners with a distributor in international markets who will take on the marketing and distribution costs in return
for a lower transfer price; in addition, end market pricing in some international markets is lower than in the US. International sales are, however, a key
component of Vycor Medicals growth strategy and the profitability of these sales may not reach acceptable levels. Furthermore Vycor Medical may not be
able to attract suitable distribution partners in all the markets it wishes to sell into.
The existing business model for the delivery of NovaVision results in
high capital costs and relatively high infrastructure costs. As a result, the pricing of the therapy needs to be sufficient to cover these costs and this
pricing limits volume. A key component of NovaVisions growth strategy is centered around the development of a much lower cost delivery model which will
enable NovaVision to significantly lower the price of its therapy to patients. There is no assurance, however, that this development can be successfully
completed or result in the level of cost reduction currently envisaged. Whilst management believes that cost to patient is a key decision factor, there is no
assurance that lowered cost will automatically lead to more widespread adoption and the barriers may well be something not currently identified by management.
We might incur substantial expense to develop products that,
once commercialized, are never sufficiently successful.
Our growth strategy requires the successful development and launch of
new products for Vycor Medical and new therapies for NovaVision. Although management will take every precaution to ensure that such expenditure is only on new
products and therapies with a high likelihood of achieving commercial success, there can be no assurance that this will be the case. The causes for failure of
new products and therapies once commercialized are numerous, including:
|
|
|
|
|
market demand for the product or therapy
proves to be smaller than market research suggested;
|
|
|
competitive products or therapies with
superior performance either on the market or commercialized at the same time or soon after;
|
|
|
product or therapy development turns out
to be more costly than anticipated or takes longer;
|
|
|
product or therapy requires significant
adjustment post commercialization, or multiple additional sizes, rendering the project uneconomic or extending considerably the likely investment return period;
|
|
|
additional regulatory requirements which
extend the time to launch and increase the overall costs of the development;
|
|
|
patent conflicts or unenforceable
intellectual property rights;
|
|
|
neurosurgeons and other physicians may
be unwilling to adapt to new products and therapies, which will slow new product adoption;
|
|
|
new products and therapies will be
dependent, to a greater or lesser extent, on the successful outcomes of clinical studies. These may cost more, take longer to complete, the outcomes maybe
inconclusive, and it may be difficult to achieve publication in an important journal; and
|
|
|
other factors that could make the
product uneconomical.
|
We might incur substantial expense to develop products that are never successfully
developed and commercialized.
We have incurred and expect to continue to incur research and
development and other expenses in developing new medical devices and therapies. The potential products and therapies to which we devote resources might never be
successfully developed or fully commercialized by us for numerous reasons, including:
|
|
|
|
|
inability to develop products and
therapies that address our customers needs;
|
|
|
competitive products with superior
performance;
|
|
|
additional regulatory requirements which
render the development uneconomic or prevent our ability to gain regulatory approval;
|
10
|
|
|
|
|
patent conflicts or unenforceable
intellectual property rights;
|
|
|
demand for the particular product; and
|
|
|
other factors that could make the
product uneconomical.
|
Incurring significant expenses for a potential product or therapy that is not
successfully developed and/or commercialized could have a material adverse effect on our business, financial condition, prospects and share price.
We may not be able to successfully expand our business through
acquisitions.
We review corporate and product line acquisition candidates as a part of
our growth strategy. If we decided to undertake an acquisition, we may not be able to successfully integrate it in order to realize the full benefit of such
acquisition. Factors which may affect our ability to grow successfully through acquisitions include:
|
|
|
|
|
inability to identify suitable targets
given the relatively narrow scope of our business;
|
|
|
inability to obtain acquisition or
additional working capital financing due to our financial condition and recent performance;
|
|
|
difficulties and expenses in connection
with integrating the acquired companies and achieving the expected benefits;
|
|
|
diversion of management’s
attention from current operations;
|
|
|
the possibility that we may be adversely
affected by risk factors facing the acquired companies;
|
|
|
acquisitions could be dilutive to
earnings, or in the event of acquisitions made through the issuance of our common shares to the shareholders of the acquired company, dilutive to the percentage
of ownership of our existing shareholders;
|
|
|
potential losses resulting from
undiscovered liabilities of acquired companies not covered by the indemnification we may obtain from the seller; and
|
|
|
loss of key employees of the acquired
companies.
|
We
cannot be certain that we will obtain patents for our devices and technology or that such patents will protect us from competitors.
We believe that our success and competitive position will depend in part
on our ability to obtain and maintain patents for our devices, which is both costly and time consuming. We have 40 issued patents covering both NovaVision,
Sight Science and Vycor Medical. We still are in the process of prosecuting 15 others. Patent Offices typically requires 12-24 months or more to process a
patent application. There can be no assurance that the remainder of our patent applications will be approved. However we have not waited for the approval of the
patent applications before launching sales of our devices and therapies. There can be no assurance regarding how long it will take the U.S. Patent and Trademark
Office to decide whether to approve our patent applications or how long it will take foreign patent offices to grant us patents. There can be no assurance that
any patent issued or licensed to us will provide us with protection against competitive products and therapies, protect us against changes in industry trends
which we have not anticipated or otherwise protect our commercial viability, or that challenges will not be instituted against the validity or enforceability of
any of our patents or, if instituted, that such challenges will not be successful. The cost of litigation to uphold the validity of a patent and enforce it
against infringement can be substantial and we do not have patent insurance. Even issued patents may later be modified or revoked by the Patent and Trademark
Office or in legal proceedings. Patent applications in the United States are maintained in secrecy until the patent issues and, since publication of discoveries
in the scientific or patent literature tends to lag behind actual discoveries, we cannot be certain that we were the first creator of the inventions covered by
our pending patent applications or the first to file patent applications on such inventions.
11
Vycor Medical is dependent on sub-contractors to manufacture our products.
Vycor Medical is dependent on sub-contract manufacturers to provide a
full range of engineering, contract manufacturing and logistical support to manufacture our products. We are dependent upon their manufacture of our products in
accordance with our specifications and delivering them on a timely basis.
Lacey Manufacturing Company manufactures 6 of our 12 VBAS models. C&J Industries
formally manufactured the remaining 6 VBAS models, but the manufacturing contract formally expired during the first quarter of 2014. Vycor Medical holds
sufficient inventory for its foreseeable needs and is in discussions with selected qualified sub-contract manufacturers to replace C&J Industries.
We can offer no assurances that we will be successful in finding an alternate manufacturer and negotiating acceptable terms with them on
a timely basis without impact on our future manufacturing and delivery schedule.
Sub-contract manufacturers are subject to regulatory requirements and
certifications. Loss of such certification would affect our ability to deliver products.
Vycor Medicals relatively low volumes limit the ability to lower
manufacturing costs.
Although the gross margins for Vycor Medicals products are
acceptable, manufacturing costs are volume-dependent. As the VBAS range comprises 12 different sizes, costs will only reduce further once volumes for each of
the 12 sizes increase. Sub-contract manufacturers have the right to pass on raw material increases which are outside of our control and may further negatively
impact margins.
We will need additional distribution and marketing partners to help us market
our products.
At this time, we have a small number of sales and marketing personnel
and limited distribution and marketing channels that we will need to expand in the future. Vycor Medical has contracted with independent medical device
distributors and representatives that collectively have field salespeople who call on neurosurgery departments both in the US and internationally. To implement
our growth plan we need to expand the US and international scope of our sales and distribution. Given the relatively small size of our company and the fact that
our products and therapies are new with currently limited sales, there is no assurance that we will be able to attract successful distributors to contract with
us. There is also no assurance that the contracted distributors or potential new distributors will be successful in promoting and selling our products and
therapies.
In addition, monitoring international distributors and interfacing
with potential international customers and other partners is made harder given the size of our company.
We will need to increase the size of our organization, and may
experience difficulties in managing growth.
We are a small company with minimal employees. We expect to
experience a period of expansion in headcount, facilities, infrastructure and overhead and anticipate that further expansion will be required to address
potential growth and market opportunities. Future growth will impose significant added responsibilities on members of management, including the need to
identify, recruit, maintain and integrate new managers. Our future financial performance and its ability to compete effectively will depend, in part, on its
ability to manage any future growth effectively.
The loss of our key personnel could adversely affect our
business. We may not be able to hire and retain qualified personnel to support our growth and if we are unable to retain or hire such personnel in the future,
our ability to improve our products and implement our business objectives could be adversely affected.
Our success depends to a significant extent upon the efforts of our
senior management team and other key personnel. The loss of the services of such personnel could adversely affect our business and our ability to implement our
growth plan. We cannot assure you that the services of the members of our management team will continue to be available to us, or that we will be able to
find a suitable replacement for any of them. We do not have key man insurance on any members of our management team. If any member of our management team were
to die and we are unable to replace either or both of them for a prolonged period of time, we may be unable to carry out our long term business plan and our
future prospect for growth, and our business, may be harmed.
Also, because of the nature of our business, our success is dependent
upon our ability to attract, train, manage and retain sales, marketing and other qualified personnel. There is substantial competition for qualified
personnel, and an inability to recruit or retain qualified personnel may impact our ability to implement our strategy to grow our business and compete
effectively in our industry.
12
Even though our current products and therapies are approved by regulatory authorities,
if we or our suppliers fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our products or therapies, these
products or therapies could be subject to restrictions or withdrawal from the market.
Any product or therapy which we obtain marketing approval, along with
the manufacturing processes, post-approval clinical data and promotional activities for such product or therapy, will be subject to continual review and
periodic inspections by the FDA and other regulatory bodies. In particular we and our suppliers are required to comply with the Quality System Regulation, or
QSR, for the manufacture of our products and delivery of our therapies which cover the methods and documentation of the design, testing, production, control,
quality assurance, labeling, packaging, storage and shipping of any product or therapy for which we obtain marketing approval. The FDA enforces the GMP and QSR
through unannounced inspections. We and our third party manufacturers and suppliers will have to successfully complete such inspections. Failure by us or one of
our suppliers, with statutes and regulations administered by the FDA and other regulatory bodies, or failure to take adequate response to any observations,
could result in, among other things, any of the following enforcement actions:
|
|
|
warning letters or untitled letters;
|
|
fines and civil penalties;
|
|
unanticipated expenditures;
|
|
withdrawal or suspension of approval by the FDA or other regulatory bodies;
|
|
product recall or seizure;
|
|
orders for physician notification or device repair, replacement or refund;
|
|
interruption of production;
|
|
operating restrictions;
|
|
injunctions; and
|
|
criminal prosecution.
|
If any of these actions were to occur it would harm our reputation and cause our product or
therapy sales and profitability to suffer, and such sales may take a long time to recover from such action, if at all. Furthermore, our key component suppliers
may not currently be or may not continue to be in compliance with applicable regulatory requirements.
If the FDA determines that our promotional materials, training or
other activities constitutes promotion of an unapproved use, it could request that we cease or modify our training or promotional materials or subject us to
regulatory enforcement actions. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our training
or other promotional materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory
authorities, such as laws prohibiting false claims for reimbursement.
13
Moreover, any modification to a device that has received FDA approval that could
significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design or manufacture, requires a new approval
from the FDA. If the FDA disagrees with any determination by us that new approval is not required, we may be required to cease marketing or to recall the
modified product until we obtain approval. In addition, we could also be subject to significant regulatory fines or penalties.
In addition, we may be required to conduct costly post-market testing
and surveillance to monitor the safety or efficacy of our products, and we will be required to report adverse events and malfunctions related to our products.
Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or
frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR or GMP, may result in restrictions on such products or
manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, fines, suspension of regulatory approvals, product
seizures, injunctions or the imposition of civil or criminal penalties.
Further, healthcare laws and regulations may change significantly in
the future. Any new healthcare laws or regulations may adversely affect our business. A review of our business by courts or regulatory authorities may result in
a determination that could adversely affect our operations. Also, the healthcare regulatory environment may change in a way that restricts our operations.
In Europe, the relevant European authorities could hold imports from
us and remove CE marking for violating their rules and regulations. We could get a warning from a European Competent Authority or its Notified Body and we would
be obligated to fix the problem and follow up with either the Notified Body or Competent Authorities.
Similarly, in other international markets for which Vycor
Medicals currently have full or partial regulatory approval (Australia, Canada, China, Japan, Korea and Russia) or where it is currently seeking approval
(Brazil, India, Taiwan and Vietnam), the relevant regulatory body could place a hold on imports from us and could revoke any licenses held for violations of its
rules and regulations. The relevant regulatory body could issue a warning the first time around and we would be obligated to fix the problem and follow up, or
regulations could change invalidating our approvals
Because product liability is inherent in the medical devices
industry and insurance is expensive and difficult to obtain, we may be exposed to large lawsuits.
Our business exposes us to potential product liability risks, which
are inherent in the manufacturing, marketing and sale of medical devices. While we will take precautions we deem to be appropriate to avoid product liability
suits against us, there can be no assurance that we will be able to avoid significant product liability exposure. Product liability insurance for the medical
products industry is generally expensive. While we have product liability coverage for our Vycor Medical devices, and product liability and professional
indemnity insurance for our NovaVision and Sight Science therapies, there can be no assurance that we will be able to continue to obtain such coverage on
acceptable terms, or that any insurance policy will provide adequate protection against potential claims. A successful product liability claim brought against
us may exceed any insurance coverage secured by us and could have a material adverse effect on our results or ability to continue marketing our products.
The other insurances we have are Directors and Officers Liability
Insurance and certain commercial liability and personal property insurances at present. We may have exposure in the event of loss or damage to our properties.
We have not established any reserve funds for potential warranty
claims. If we experience an increase in warranty claims or if our repair and replacement costs associated with warranty claims increase significantly, it would
have a material adverse effect on our financial condition and results of operations.
Because the healthcare industry is subject to changing policies
and procedures, we may find it difficult to continue to compete in an uncertain environment.
The health care industry is subject to changing political, economic
and regulatory influences that may affect the procurement practices and operations of healthcare industry participants. During the past several years government
regulation of the healthcare industry has changed significantly in several countries. Healthcare industry participants may react to new policies by curtailing
or deferring use of new treatments for disease, including treatments that would use our devices. This could substantially impair our ability to successfully
marker our products, which would have a material adverse effect on our performance.
14
The market success of our products and therapies may be dependent in part upon
third-party reimbursement policies that are often subject to change.
Our ability to successfully penetrate the market for our products and
therapies may to some extent depend on the availability of reimbursement to individuals for rehabilitation therapies and to hospitals for neurosurgical
procedures from third-party payers, such as governmental programs, private insurance and private health plans. There is no guarantee that this will not change
in the future or that applicable levels of reimbursement to individuals and hospitals, if any, will be high enough to allow us to charge a reasonable profit
margin. Vycor Medicals products are not specifically reimbursed by third party payers, they are part of the overall procedure cost and therefore some
hospitals may view this as an increase in cost. If levels of reimbursement are decreased in the future, the demand for our products could diminish or our
ability to sell our products on a profitable basis could be adversely affected. NovaVisions therapies are not generally reimbursed by third party payers,
although this is sometimes available to patients on a case-by-case basis.
We may be affected by health care
reform.
In March 2010, the United States Congress enacted health care reform
legislation intended over time to expand health insurance coverage and impose health industry cost containment measures. This legislation may impact the
sales of our medical devices and therapies. In addition, the U.S. Congress, various state legislatures and European and Asian governments may consider
various types of health care reform in order to control growing health care costs. We are presently uncertain as to the effects of the recently enacted
legislation on our business and are unable to predict what legislative proposals will be adopted in the future, if any.
Risks Related to Share Ownership
We are subject to compliance with securities law, which exposes
us to potential liabilities, including potential rescission rights.
We have offered and sold our Common Stock to investors pursuant to
certain exemptions from the registration requirements of the Securities Act of 1933, as well as those of various state securities laws. The basis for relying on
such exemptions is factual; that is, the applicability of such exemptions depends upon our conduct and that of those persons contacting prospective investors
and making the offering. We have not received a legal opinion to the effect that any of our prior offerings were exempt from registration under any federal or
state law. Instead, we have relied upon the operative facts as the basis for such exemptions, including information provided by investors themselves.
If any prior offering did not qualify for such exemption, an investor
would have the right to rescind its purchase of the securities if it so desired. It is possible that if an investor should seek rescission, such investor would
succeed. A similar situation prevails under state law in those states where the securities may be offered without registration in reliance on the partial
preemption from the registration or qualification provisions of such state statutes under the National Securities Markets Improvement Act of 1996. If investors
were successful in seeking rescission, we would face severe financial demands that could adversely affect our business and operations. Additionally, if we did
not in fact qualify for the exemptions upon which it has relied, we may become subject to significant fines and penalties imposed by the SEC and state
securities agencies.
Fountainhead Capital Management Limited (Fountainhead)
owns over 40% of our common stock together with certain debt holdings and may be able to influence the outcome of stockholder votes and their interests may
differ from other stockholders.
As of
May 23, 2014
, Fountainhead beneficially owned, in the aggregate, approximately 40.6% of our Common Stock. As a result of this ownership
concentration, they may be able to influence the outcome of stockholder votes on various matters, including the election of directors and extraordinary
corporate transactions, including business combinations. Their interests may differ from other stockholders. In addition, at March 31, 2014, Fountainhead
holds $616,362 of the Companys convertible debt, which together with accrued interest is convertible into an additional approximately 348,982 shares
of Company Common Stock, and Fountainhead and related parties hold an additional $
1,630,675 non-convertible debt.
Two of the Companys members of management and the board of directors (David Cantor and Peter Zachariou) serve as investment managers of Fountainhead
and one of the Companys members of management and board of directors (Adrian Liddell) serves as an advisor to Fountainhead
In addition, Fountainhead receives consulting fees for its strategic advisory services to the Company.
15
Our share price could be volatile and our trading volume may fluctuate
substantially.
The price of our common shares has been and may in the future continue to be
extremely volatile, with the sale price fluctuating from a low of $1.12 to a high of $
3.90
since November 18, 2011
. Many factors could have a significant impact on the future price of our common shares, including:
|
|
|
|
·
|
our inability to raise additional capital to fund our
operations, whether through the issuance of equity securities or debt;
|
|
·
|
our failure to successfully implement our business
objectives and strategic growth plans;
|
|
·
|
compliance with ongoing regulatory requirements;
|
|
·
|
market acceptance of our products;
|
|
·
|
changes in government regulations;
|
|
·
|
general economic conditions and other external
factors;
|
|
·
|
actual or anticipated fluctuations in our quarterly
financial and operating results; and
|
|
·
|
the degree of trading liquidity in our common shares.
|
The availability of
a large number of authorized but unissued shares of Common Stock may, upon their issuance, lead to dilution of existing stockholders.
We are authorized to issue 25,000,000 shares of Common Stock, $0.0001
par value per share, of which, as of
May 23, 2014 10,703,494
shares of Common Stock were
issued and outstanding. These shares may be issued by our board of directors without further stockholder approval. The issuance of large numbers of shares,
possibly at below market prices, is likely to result in substantial dilution to the interests of other stockholders. In addition, issuances of large numbers of
shares may adversely affect the market price of our Common Stock.
Further, our Certificate of Incorporation authorizes 10,000,000
shares of preferred stock, $0.0001 par value per share of which as of
May 23, 2014
one (1)
share of preferred stock was issued and outstanding. The board of directors is authorized to provide for the issuance of these unissued
shares of preferred stock in one or more series, and to fix the number of shares and to determine the rights, preferences and privileges thereof. Accordingly,
the board of directors may issue preferred stock which may convert into large numbers of shares of Common Stock and consequently lead to further dilution of
other shareholders.
Our Common Stock could be further diluted as
the result of the issuance of convertible securities, warrants or options.
In the past, we have issued convertible securities (such as convertible debentures and
notes), warrants and options in order to raise money or as compensation for services and incentive compensation for our employees and directors. As of March 31,
2014, the Company has outstanding (a) 916,362 of convertible debt outstanding, which if fully converted together with accrued interest would result in the
issuance of an additional approximately 520,120 shares of Company Common Stock and (b) warrants and options to purchase approximately 5.6 million shares of
Company Common Stock. We have shares of Common Stock reserved for issuance upon the exercise of certain of these securities and may increase the shares
reserved for these purposes in the future. Our issuance of these convertible securities, options and warrants could affect the rights of our stockholders, could
reduce the market price of our Common Stock or could result in adjustments to exercise prices of outstanding warrants (resulting in these securities becoming
exercisable for, as the case may be, a greater number of shares of our Common Stock), or could obligate us to issue additional shares of Common Stock to certain
of our stockholders. All of these actions could serve to dilute the interests of the holders of our Common Stock.
16
We have never paid cash dividends and do not anticipate doing so in the foreseeable future.
We have never declared or paid cash dividends on our common shares. We
currently plan to retain any earnings to finance the growth of our business rather than to pay cash dividends. Payments of any cash dividends in the future will
depend on our financial condition, results of operations and capital requirements, as well as other factors deemed relevant by our board of directors.
Our Common Stock is subject to the "Penny Stock" rules of
the SEC and the trading market in our securities is limited, which makes transactions in our stock cumbersome and may reduce the value of an investment in our
stock.
The Securities and Exchange Commission has adopted Rule 15g-9 which
establishes the definition of a "penny stock," for the purposes relevant to us, as any equity security that has a market price of less than $5.00 per
share or with an exercise price of less than $5.00 per share, subject to certain exceptions. For any transaction involving a penny stock, unless exempt, the
rules require:
|
|
|
|
·
|
That a broker or dealer approve a person's account for
transactions in penny stocks; and
|
|
·
|
The broker or dealer receives from the investor a written
agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.
|
In order to approve a person's account for transactions in penny stocks,
the broker or dealer must:
|
|
|
|
·
|
Obtain financial information and investment experience
objectives of the person; and
|
|
·
|
Make a reasonable determination that the transactions in penny
stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of
transactions in penny stocks.
|
The broker or dealer must also deliver, prior to any transaction in a
penny stock, a disclosure schedule prescribed by the Commission relating to the penny stock market, which, in highlight form:
|
|
|
|
·
|
Sets forth the basis on which the broker or dealer made the
suitability determination; and
|
|
·
|
That the broker or dealer received a signed, written agreement
from the investor prior to the transaction.
|
Generally, brokers may be less willing to execute transactions in
securities subject to the "penny stock" rules. This may make it more difficult for investors to dispose of our Common Stock and cause a decline in the
market value of our stock.
Disclosure also has to be made about the risks of investing in penny
stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer and the registered representative, current
quotations for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements
have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.
17
Financial Industry Regulatory Authority, Inc. (FINRA)
sales practice requirements may limit a shareholders ability to buy and sell our Common Stock.
In addition to the penny stock rules described above, FINRA
has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment
is suitable for that customer. Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must make reasonable
efforts to obtain information about the customers financial status, tax status, investment objectives and other information. Under interpretations of
these rules, FINRA believes that there is a high probability that speculative low priced securities will not be suitable for at least some customers. FINRA
requirements make it more difficult for broker-dealers to recommend that their customers buy our Common Stock, which may limit your ability to buy and sell our
stock and have an adverse effect on the market for our shares.
Our stock is thinly traded, so you may be unable to sell your
shares at or near the quoted bid prices if you need to sell a significant number of your shares, and a sale of your holding may take a considerable amount of
time.
The shares of our Common Stock are thinly-traded on the OTC Bulletin
Board, meaning that the number of persons interested in purchasing our Common Stock at or near bid prices at any given time may be relatively small or
non-existent. As a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared
to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share
price. We cannot give you any assurance that a broader or more active public trading market for our Common Stock will develop or be sustained, or that current
trading levels will be sustained. Due to these conditions, we can give you no assurance that you will be able to sell your shares at or near bid prices or at
all if you need money or otherwise desire to liquidate your shares.
Shares eligible for future sale may adversely affect the market.
From time to time, certain of our stockholders may be eligible to sell
all or some of their shares of Common Stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144 promulgated under the Securities
Act, subject to certain limitations. In general, pursuant to amended Rule 144, non-affiliate stockholders may sell freely after six months subject only to the
current public information requirement. Affiliates may sell after six months subject to the Rule 144 volume, manner of sale (for equity securities), current
public information and notice requirements. Any substantial sales of our Common Stock pursuant to Rule 144 may have a material adverse effect on the market
price of our Common Stock.
If we fail to maintain effective internal controls over financial reporting, the price of our Common Stock may be adversely affected.
Our internal control over financial reporting may have weaknesses and
conditions that could require correction or remediation, the disclosure of which may have an adverse impact on the price of our Common Stock. We are
required to establish and maintain appropriate internal controls over financial reporting. Failure to establish those controls, or any failure of those
controls once established, could adversely affect our public disclosures regarding our business, prospects, financial condition or results of operations.
In addition, managements assessment of internal controls over financial reporting may identify weaknesses and conditions that need to be addressed
in our internal controls over financial reporting or other matters that may raise concerns for investors. Any actual or perceived weaknesses and
conditions that need to be addressed in our internal control over financial reporting or disclosure of managements assessment of our internal controls
over financial reporting may have an adverse impact on the price of our Common Stock.
We are required to comply with certain provisions of Section 404 of
the Sarbanes-Oxley Act of 2002 and if we fail to comply in a timely manner, our business could be harmed and our stock price could decline.
Rules adopted by the SEC pursuant to Section 404 of the Sarbanes-Oxley
Act of 2002 require an annual assessment of internal controls over financial reporting, and for certain issuers an attestation of this assessment by the
issuers independent registered public accounting firm. The standards that must be met for management to assess the internal controls over financial
reporting as effective are evolving and complex, and require significant documentation, testing, and possible remediation to meet the detailed standards.
We expect to incur expenses and to devote resources to Section 404 compliance on an ongoing basis. It is difficult for us to predict how long it
will take or costly it will be to
18
complete the assessment of the effectiveness of our internal control over financial reporting
for each year and to remediate any deficiencies in our internal control over financial reporting. As a result, we may not be able to complete the assessment and
remediation process on a timely basis. In addition, although attestation requirements by our independent registered public accounting firm are not
presently applicable to us we could become subject to these requirements in the future and we may encounter problems or delays in completing the implementation
of any resulting changes to internal controls over financial reporting. In the event that our Chief Executive Officer or Chief Financial Officer determine
that our internal control over financial reporting is not effective as defined under Section 404, we cannot predict how regulators will react or how the market
prices of our shares will be affected; however, we believe that there is a risk that investor confidence and share value may be negatively affected.
USE OF PROCEEDS
This prospectus relates to the resale of our common stock that may be offered and sold from
time to time by the selling stockholders. We will not receive any proceeds from the sale of shares of common stock in this offering.
DETERMINATION OF OFFERING PRICE
All shares of our common stock being offered will be sold by the selling stockholders without
our involvement. It is our expectation that the selling shareholders will sell their shares at the market prices prevailing from time-to-time.
DILUTION
The common stock to be sold by the selling shareholders is common stock that is currently
issued or will be issued to our shareholders upon exercise of certain Warrants issued by the Company. Accordingly, there will be no dilution to our existing
shareholders from these sales, other than from the exercise of the Warrants.
SELLING STOCKHOLDERS
The following table sets forth the number of shares of Company common stock owned and
issuable on the exercise of warrants beneficially owned, as of the date of this prospectus, by the selling stockholders prior to the offering contemplated by
this prospectus, the number of shares which are issuable on the exercise of warrants beneficially owned by each selling stockholder which is being offered by
this prospectus and the number of shares which are issuable on the exercise of warrants beneficially owned which each selling stockholder would own beneficially
if all such offered shares are sold. None of the selling stockholders is known to us to be a registered broker-dealer or an affiliate of a registered
broker-dealer. Each of the selling stockholders has acquired his, her or its shares solely for investment and not with a view to or for resale or
distribution of such securities. Beneficial ownership is determined in accordance with SEC rules and includes voting or investment power with respect
to the securities.
19
|
|
|
|
|
|
|
|
|
|
Name (1)
|
Shares of Common Stock
Owned Prior to the
Offering
|
Shares of Common Stock
to be Sold (2)
|
Shares of Common Stock
Owned After the Offering
|
Percentage of Common Stock
Owned After This Offering
|
|
|
|
|
|
Abrams, Dennis IRA/ RBC Capital
Markets Corp. F.B.O.
|
44,447
|
44,447
|
0
|
0.00%
|
Altieri, Francis IRA/ RBC Capital Markets
Corp. F.B.O
|
20,000
|
20,000
|
0
|
0.00%
|
Bagley, Jr. Theodore
|
22,224
|
22,224
|
0
|
0.00%
|
Behar, Michael Roth IRA / RBC
Capital Markets Corp. F.B.O.
|
110,000
|
110,000
|
0
|
0.00%
|
Bob Bridges
|
27,779
|
27,779
|
0
|
0.00%
|
Dell'Aera, Mario
|
357,780
|
357,780
|
0
|
0.00%
|
Herbranson, Dale E.
|
22,224
|
22,224
|
0
|
0.00%
|
Jenkins, Steven IRA / RBC Capital Markets
Corp. LLC Cust
|
66,670
|
66,670
|
0
|
0.00%
|
Mathias, William
|
27,779
|
27,779
|
0
|
0.00%
|
McLoughlin, Mick
|
222,224
|
222,224
|
0
|
0.00%
|
Moroney, Robert and Carole R. JTTEN
|
27,779
|
27,779
|
0
|
0.00%
|
Pileggi, Kenneth W. IRA / RBC Capital
Markets Corp. FBO
|
16,000
|
16,000
|
0
|
0.00%
|
Scott, Duncan
|
33,335
|
33,335
|
0
|
0.00%
|
Timothy H. Shear DEC of Trust DTD 1/6/1994
|
16,668
|
16,668
|
0
|
0.00%
|
Skutt, Glenn Richard & Lesley Howard
JTTEN
|
55,558
|
55,558
|
0
|
0.00%
|
Takada, Hideo
|
200,000
|
200,000
|
0
|
0.00%
|
Teicher, Howard
|
8,335
|
8,335
|
0
|
0.00%
|
Abbott, Dennis IRA / RBC Capital Markets
Corp. FBO
|
27,779
|
27,779
|
0
|
0.00%
|
Wallitt, Steve
|
33,335
|
33,335
|
0
|
0.00%
|
Giordano, Nicholas
|
66,668
|
66,668
|
0
|
0.00%
|
Abrams, Mark
|
277,780
|
277,780
|
0
|
0.00%
|
Richards, Donald J.
|
100,000
|
100,000
|
0
|
0.00%
|
Iacobello, Paul & Gina
|
22,224
|
22,224
|
0
|
0.00%
|
Fountainhead Capital Partners Limited
|
794,280
|
794,280
|
0
|
0.00%
|
Steven R. Antico
|
27,779
|
27,779
|
0
|
0.00%
|
Alan Antokal
|
111,112
|
111,112
|
0
|
0.00%
|
The Apregan Family Trust DTD 2/11/98
|
55,556
|
55,556
|
0
|
0.00%
|
Peter Backus
|
200,003
|
200,003
|
0
|
0.00%
|
Michael G. Cadwell
|
83,335
|
83,335
|
0
|
0.00%
|
Richard A. Cloyd
|
120,000
|
120,000
|
0
|
0.00%
|
Jason Cohen
|
166,668
|
166,668
|
0
|
0.00%
|
20
|
|
|
|
|
Chad Critchley
|
55,556
|
55,556
|
0
|
0.00%
|
Scott Cunningham
|
33,335
|
33,335
|
0
|
0.00%
|
Duncan Scott
|
55,556
|
55,556
|
0
|
0.00%
|
Donald P. Favre
|
55,556
|
55,556
|
0
|
0.00%
|
RBC Capital Markets Corp. FBO Susan A
Izard IRA
|
27,779
|
27,779
|
0
|
0.00%
|
Alistair Eric Maccallum Laband
|
111,112
|
111,112
|
0
|
0.00%
|
Steven L. Lew
|
7,779
|
7,779
|
0
|
0.00%
|
James P. Little
|
44,447
|
44,447
|
0
|
0.00%
|
Raylan Loggins
|
33,335
|
33,335
|
0
|
0.00%
|
Michael Lutze
|
140,000
|
140,000
|
0
|
0.00%
|
Ulrich Otto
|
83,335
|
83,335
|
0
|
0.00%
|
David Rush
|
222,224
|
222,224
|
0
|
0.00%
|
William C. Slater
|
11,112
|
11,112
|
0
|
0.00%
|
Timothy Shear Dec of Trust DTD 1/6/1974
|
28,000
|
28,000
|
0
|
0.00%
|
Salman Wakil
|
100,000
|
100,000
|
0
|
0.00%
|
Orville A. White
|
111,112
|
111,112
|
0
|
0.00%
|
Chris Hayden
|
44,447
|
44,447
|
0
|
0.00%
|
Hugo Were
|
166,668
|
166,668
|
0
|
0.00%
|
Stephan Forstmann
|
22,224
|
22,224
|
0
|
0.00%
|
Altshuler, Howard
|
27,779
|
27,779
|
0
|
0.00%
|
RBC Capital Markets LLC FBO Michael A
Boulus IRA
|
55,556
|
55,556
|
0
|
0.00%
|
Brickley, Robert J.
|
16,668
|
16,668
|
0
|
0.00%
|
DiBenedetto, Robert D.
|
11,112
|
11,112
|
0
|
0.00%
|
Fogle, Richard
|
27,779
|
27,779
|
0
|
0.00%
|
Kaspar, Mark
|
55,556
|
55,556
|
0
|
0.00%
|
MacKenzie, Kevin M.
|
55,556
|
55,556
|
0
|
0.00%
|
Nesland, Brett
|
30,000
|
30,000
|
0
|
0.00%
|
Rey 1998 Family Trust
|
111,112
|
111,112
|
0
|
0.00%
|
Sweeney, David
|
5,600
|
5,600
|
0
|
0.00%
|
Trafford, John
|
83,335
|
83,335
|
0
|
0.00%
|
Ufheil, David A.
|
55,556
|
55,556
|
0
|
0.00%
|
21
|
|
|
|
|
Simon, Michael & Mary
|
22,224
|
22,224
|
0
|
0.00%
|
Boltz, Willliam
|
83,335
|
83,335
|
0
|
0.00%
|
Sedberry, Erica Pitman
|
83,335
|
83,335
|
0
|
0.00%
|
Apgar, Christopher
|
83,335
|
83,335
|
0
|
0.00%
|
Shankara, Srinivas
|
22,224
|
22,224
|
0
|
0.00%
|
Scheuer, Ricardon & Silvia Suarez
|
150,000
|
150,000
|
0
|
0.00%
|
Barba, Randolph
|
55,556
|
55,556
|
0
|
0.00%
|
Bell, Stephen
|
17,000
|
17,000
|
0
|
0.00%
|
Cranshire Capital Master Fund LTD
|
83,336
|
83,336
|
0
|
0.00%
|
Equitec Specialists LLC
|
27,776
|
27,776
|
0
|
0.00%
|
Fisher, Patricia
|
11,112
|
11,112
|
0
|
0.00%
|
Gissler, Donald
|
55,556
|
55,556
|
0
|
0.00%
|
RBC Capital Markets LLC FBO Gregory J
Carter IRA
|
55,556
|
55,556
|
0
|
0.00%
|
Hoffman, Michael L.
|
27,779
|
27,779
|
0
|
0.00%
|
Kayman, Rob
|
55,556
|
55,556
|
0
|
0.00%
|
King, David
|
13,335
|
13,335
|
0
|
0.00%
|
Koncsics, Tom
|
111,112
|
111,112
|
0
|
0.00%
|
Kytomaa, Harri
|
11,112
|
11,112
|
0
|
0.00%
|
RBC Capital Markets LLC Linda Friedman
Roth IRA
|
5,556
|
5,556
|
0
|
0.00%
|
Prayaga, Sankar and Prayaga Gayathri JTTEN
|
6,000
|
6,000
|
0
|
0.00%
|
Todd Channell Trust
|
111,112
|
111,112
|
0
|
0.00%
|
Richard Hoffman
|
12,500
|
12,500
|
0
|
0.00%
|
Hugh Campbell
|
5,556
|
5,556
|
0
|
0.00%
|
Fraser Campbell
|
5,556
|
5,556
|
0
|
0.00%
|
Boris and Alexandra Smirnoff
|
55,556
|
55,556
|
0
|
0.00%
|
Nadejda Kassatkina
|
55,556
|
55,556
|
0
|
0.00%
|
Irina Pavlova
|
27,778
|
27,778
|
0
|
0.00%
|
Apex Technology Ventures, LLC
|
27,778
|
27,778
|
0
|
0.00%
|
Robert S. Prag
|
44,446
|
44,446
|
0
|
0.00%
|
JSL Kids Partners
|
72,224
|
72,224
|
0
|
0.00%
|
Thomas Varga TTEE Prag Childrens
Trust FBO Andrew Prag
|
15,278
|
15,278
|
0
|
0.00%
|
22
|
|
|
|
|
Thomas Varga TTEE Prag Childrens
Trust FBO Robert Prag Jr.
|
15,278
|
15,278
|
0
|
0.00%
|
RBC Capital Markets LLC FBO Jane Ellis
|
55,556
|
55,556
|
0
|
0.00%
|
Guri Dauti
|
27,778
|
27,778
|
0
|
0.00%
|
|
|
|
|
|
Total
|
6,767,254
|
6,767,254
|
-
|
-
|
|
|
(1)
|
All shares are owned of record and
beneficially unless otherwise indicated. Beneficial ownership information for the selling stockholders is provided as of May 23, 2014, based upon information
provided by the selling stockholders or otherwise known to us.
|
|
(2)
|
Assumes the sale of all shares of common stock registered
pursuant to this prospectus. The selling stockholders are under no obligation known to us to sell any shares of common stock at this time.
|
PLAN OF DISTRIBUTION
Each Selling Stockholder (the
Selling Stockholders
) of the securities and
any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on the principal Trading
Market or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed
or negotiated prices. A Selling Stockholder may use any one or more of the following methods when selling securities:
·
ordinary brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
·
block trades in which the broker-dealer will attempt to sell the securities as
agent but may position and resell a portion of the block as principal to facilitate the transaction;
·
purchases by a broker-dealer as principal and resale by the broker-dealer for
its account;
·
an exchange distribution in accordance with the rules of the applicable
exchange;
·
privately negotiated transactions;
·
settlement of short sales;
·
in transactions through broker-dealers that agree with the Selling
Stockholders to sell a specified number of such securities at a stipulated price per security;
·
through the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
·
a combination of any such methods of sale; or
·
any other method permitted pursuant to applicable law.
The Selling Stockholders may also sell securities under Rule 144 under the Securities Act of
1933, as amended (the
Securities Act
), if available, rather than under this prospectus.
Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the
purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency
transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or
markdown in compliance with FINRA IM-2440.
23
In connection with the sale of the securities or interests therein, and in compliance with
applicable laws and regulations, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in
turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling Stockholders may also sell securities short
and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities.
The Selling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more
derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities
such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The Selling Stockholders and any broker-dealers or agents that are involved in selling the
securities may be deemed to be underwriters within the meaning of the Securities Act in connection with such sales. In such event, any
commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement
or understanding, directly or indirectly, with any person to distribute the securities.
The Company is required to pay certain fees and expenses incurred by the Company incident to
the registration of the securities. The Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities,
including liabilities under the Securities Act.
Because Selling Stockholders may be deemed to be underwriters within the meaning
of the Securities Act, they will be subject to the prospectus delivery requirements of the Securities Act including Rule 172 thereunder. In addition, any
securities covered by this prospectus which qualify for sale pursuant to Rule 144 under the Securities Act may be sold under Rule 144 rather than under this
prospectus. The Selling Stockholders have advised us that there is no underwriter or coordinating broker acting in connection with the proposed sale of the
resale securities by the Selling Stockholders.
We agreed to keep this prospectus effective until the earlier of (i) the date on which the
securities may be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144,
without the requirement for the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of
similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar
effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In
addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state
or an exemption from the registration or qualification requirement is available and is complied with.
Under applicable rules and regulations under the Exchange Act, any person engaged in the
distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted
period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable
provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of securities
of the common stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders and have
informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172
under the Securities Act).
DESCRIPTION OF SECURITIES TO BE REGISTERED
Our authorized capital stock consists of 25,000,000 shares of common stock, par value $0.0001
per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share, the rights and preferences of which may be established from time to time by
our board. As of May 23, 2014, there were 10,703,494 shares of common stock and one (1) share of preferred stock issued and outstanding.
Common Stock
Holders of our common stock are entitled to one vote for each share on all matters voted upon
by our stockholders, including the election of directors, and do not have cumulative voting rights. Subject to the rights of holders of any
24
then outstanding shares of our preferred stock, our common stockholders are entitled to any
dividends that may be declared by our board. Holders of our common stock are entitled to share ratably in our net assets upon our dissolution or
liquidation after payment or provision for all liabilities and any preferential liquidation rights of our preferred stock then outstanding. Holders
of our common stock have no preemptive rights to purchase shares of our stock. The shares of our common stock are not subject to any redemption
provisions and are not convertible into any other shares of our capital stock. All outstanding shares of our common stock are, and the shares of
common stock to be issued in the offering will be, upon payment therefor, fully paid and non-assessable. The rights, preferences and privileges of holders of
our common stock will be subject to those of the holders of any shares of our preferred stock we may issue in the future.
Between January 2 and April 25, 2014, the Company completed the sale of $5,000,000 in Units
comprising Common Stock and Warrants (the Units) to accredited investors (the Investors) in a private placement (the
Placement). Each Unit was priced at $1.80 and comprised one share of Company Common Stock (the Shares), a series A warrant (the
Series A Warrants
) to purchase 0.5 shares of common stock and a series B warrant (the
Series B Warrants
and together with
the Series A Warrants, the
Warrants
) to purchase 0.5 shares of common stock (the
Units
). Each Investor received (i)
3-year detachable Series A Warrants to purchase a number of shares of Common Stock equal to 50% of the number of Shares purchased by such investor and (ii)
3-year detachable Series B Warrants to purchase a number of shares of Common Stock equal to 50% of the number of Shares purchased by such investor. The
Series A Warrants have an exercise price per share of $2.05 (subject to adjustment as provided therein). The Series B Warrants have an exercise price per share
of $3.08. The Warrants are subject to adjustment for stock splits, stock dividends or recapitalizations. In the aggregate, the Company issued 2,777,808
shares of Common Stock, Series A Warrants to purchase an aggregate of 1,388,919 shares of Common Stock and Series B Warrants to purchase an aggregate of
1,388,919 shares of Common Stock.
Fountainhead Capital Partners Limited (Fountainhead), the Companys largest
shareholder with approximately 41% of the Common Stock following the Offering, additionally converted a total of $1,426,542 of accrued consulting fees into an
investment in Units under the Placement, comprising 792,523 shares of Common Stock, Series A Warrants to purchase 396,262 shares of Common Stock and Series B
Warrants to purchase 396,262 shares of Common Stock.
Based on the subscription terms applicable to the holders of the Companys
previously-issued Series C Convertible Preferred Stock, such holders were given the option of exchanging their investment in such unconverted Series C
Convertible Preferred Stock and the related warrants into the securities which are the subject of the Placement, based on the amount of their investment in the
Series C Convertible Preferred Stock and the related warrants. On February 24, 2014, the holders of 15.15 shares of Series C Convertible Preferred Stock
(representing an aggregate investment of $757,700) exchanged their Series C Convertible Preferred Stock and related warrants for an aggregate of 420,838 shares
of Common Stock, Series A Warrants to purchase an aggregate of 210,420 shares of Common Stock and Series B Warrants to purchase an aggregate of 210,420 shares
of Common Stock.
Under the terms of the Placement Agent agreement with Garden State Securities, Inc., the
Company issued an aggregate of 402,030 Placement Agent Warrants, on almost identical terms to the Series A Warrants.
The Share Purchase Agreements entered into between the Company and the Investors and the
Series A Warrant Agreements contained certain anti-dilution provisions for the Common Stock and Warrants, respectively, received under the Private Placement.
Until the twelve-month anniversary of the Effective Date (the date that the initial Registration Statement has been declared effective by the SEC) each Investor
would receive additional shares of Company Common Stock for any such additional securities issued by the Company in a subsequent financing at an effective per
share purchase price below $1.80, such rights being non-transferable. The Series A Warrants and Placement Agent Warrants had anti-dilution protection during the
same period for the issuance of Company Common Stock, or securities exercisable for or convertible into Company Common Stock, at an issuance price, exercise
price or conversion price of less than the $2.05 exercise price of the Series A Warrants. Effective May 15, 2014 the Company and the Investors entered into
waivers of the Share Purchase Agreements and Series A Warrant Agreements (the Waivers) under which the investors agreed to waive their anti-dilution
rights in consideration of the Companys agreement not to sell any securities at a price below $2.05 within the same one-year period. As of May 23, 2014 Waivers had been received in respect of approximately 95% of Investors,
as well as in respect of the Placement Agent Warrants and the Series A Warrants held by Fountainhead. As a result, as of May 23,
2014 a total of 2,334,874 of the 2,397,931 Series A Warrants and Placement Agent Warrants issued in connection with or as a result
of the Private Placement are no longer subject to anti-dilution provisions. The Company continues to seek Waivers from the remaining
Investors.
Preferred Stock
Our board may, from time to time, authorize the issuance of one or more classes or series of
preferred stock without stockholder approval. Subject to the provisions of our certificate of incorporation and limitations prescribed by law, our board is
authorized to adopt resolutions to issue shares, establish the number of shares, change the number of
25
shares constituting any series, and provide or change the voting powers, designations,
preferences and relative rights, qualifications, limitations or restrictions on shares of our preferred stock, including dividend rights, terms of redemption,
conversion rights and liquidation preferences, in each case without any action or vote by our stockholders. One of the effects of undesignated preferred stock
may be to enable our board to discourage an attempt to obtain control of our company by means of a tender offer, proxy contest, merger or otherwise. The
issuance of preferred stock may adversely affect the rights of our common stockholders by, among other things:
|
|
|
Restricting dividends on the common stock;
|
|
diluting the voting power of the common stock;
|
|
impairing the liquidation rights of the common stock; or
|
|
delaying or preventing a change in control without further action
by the stockholders.
|
Series C Convertible Preferred Stock
At this time, the only issued and outstanding preferred stock is one (1) share of Series C
Convertible Preferred Stock. Each share of Series C Preferred Convertible Stock is convertible (at the Holders option or mandatorily upon the
occurrence of certain events) into 14,815 shares of the Companys Common Stock (at $3.75 per share).
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market Information
Beginning on July 20, 2009, our Common Stock was quoted on the OTC Bulletin Board under the
symbol VYCO.
The following table shows the high and low prices of our common shares on the OTC Bulletin
Board for each quarter for fiscal years 2012 and 2013 and the first quarter of 2014. The following quotations reflect inter-dealer prices, without retail
mark-up, markdown or commission and may not necessarily represent actual transactions:
|
|
|
|
Period
|
High
|
Low
|
January 1, 2012-March 31, 2012
|
$3.00
|
$2.10
|
April 1, 2012-June 30, 2012
|
$3.30
|
$1.50
|
July 1, 2012-September 30, 2012
|
$3.30
|
$1.65
|
October 1, 2012-December 31, 2012
|
$2.67
|
$1.12
|
January 1, 2013-March 31, 2013
|
$2.10
|
$1.14
|
April 1, 2013-June 30, 2013
|
$2.95
|
$2.00
|
July 1, 2013-September 30, 2013
|
$2.69
|
$1.80
|
October 1, 2013-December 31, 2013
|
$2.70
|
$1.90
|
January 1, 2014-March 31, 2014
|
$3.06
|
$1.76
|
All stock prices are adjusted for a one for 150 reverse stock split which became effective
January 15, 2013.
The market price of our common stock, like that of other technology companies, is highly volatile
and is subject to fluctuations in response to variations in operating results, announcements of technological innovations or new products, or other events or
factors. Our stock price may also be affected by broader market trends unrelated to our performance.
26
Holders
As of May 23, 2014, there were approximately 175 record holders of our common stock and there
were 10,703,494 shares of our common stock issued and outstanding. Please see SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT for information
related to the holdings of certain beneficial owners and management of the Company.
Transfer Agent and Registrar
Our transfer agent is Corporate Stock Transfer, Inc., 3200 Cherry Creek Dr. South, Suite 430,
Denver, CO 80209, tel. (303) 282-4800.
Dividend Policy
We have never paid any cash dividends on our Common Stock and do not
anticipate paying any cash dividends on our Common Stock in the foreseeable future. We intend to retain future earnings to fund ongoing operations and future
capital requirements of our business. Any future determination to pay cash dividends will be at the discretion of the Board of Directors and will be dependent
upon our financial condition, results of operations, capital requirements
and such other factors as the Board of Directors
deems relevant.
The Securities Enforcement and Penny Stock Reform Act of 1990
The Securities and Exchange Commission has also adopted rules that regulate broker-dealer
practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00 (other than securities
registered on certain national securities exchanges or quoted on the Nasdaq system, provided that current price and volume information with respect to
transactions in such securities is provided by the exchange or system).
A purchaser is purchasing penny stock which limits the ability to sell the stock. The shares
offered by this prospectus constitute penny stock under the Securities and Exchange Act. The shares will remain penny stocks for the foreseeable future. The
classification of penny stock makes it more difficult for a broker-dealer to sell the stock into a secondary market, which makes it more difficult for a
purchaser to liquidate his/her investment. Any broker-dealer engaged by the purchaser for the purpose of selling his or her shares in us will be subject to
Rules 15g-1 through 15g-10 of the Securities and Exchange Act. Rather than creating a need to comply with those rules, some broker-dealers will refuse to
attempt to sell penny stock.
The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not
otherwise exempt from those rules, to deliver a standardized risk disclosure document prepared by the Commission, which:
|
|
|
contains a description of the nature and level of risk in the
market for penny stocks in both public offerings and secondary trading;
|
|
contains a description of the broker’s or dealer’s
duties to the customer and of the rights and remedies available to the customer with respect to a violation to such duties or other requirements of the
Securities Act of 1934, as amended;
|
27
|
|
|
contains a brief, clear, narrative description of a dealer
market, including “bid” and “ask” prices for penny stocks and the significance of the spread between the bid and ask price;
|
|
contains a toll-free telephone number for inquiries on
disciplinary actions;
|
|
defines significant terms in the disclosure document or in the
conduct of trading penny stocks; and
|
|
contains such other information and is in such form (including
language, type, size and format) as the Securities and Exchange Commission shall require by rule or regulation;
|
The broker-dealer also must provide, prior to effecting any transaction in a penny stock, to the customer:
|
|
|
the bid and offer quotations for the penny stock;
|
|
the compensation of the broker-dealer and its salesperson in
the transaction;
|
|
the number of shares to which such bid and ask prices apply, or
other comparable information relating to the depth and liquidity of the market for such stock; and
|
|
monthly account statements showing the market value of each
penny stock held in the customer’s account.
|
In addition, the penny stock rules require that prior to a transaction in a penny stock not
otherwise exempt from those rules; the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser
and receive the purchasers written acknowledgment of the receipt of a risk disclosure statement, a written agreement to transactions involving penny
stocks, and a signed and dated copy of a written suitability statement. These disclosure requirements will have the effect of reducing the trading activity in
the secondary market for our stock because it will be subject to these penny stock rules. Therefore, stockholders may have difficulty selling their securities.
Equity Compensation Plan Information
Stock Option Plan
The Company adopted the Vycor Medical, Inc Employee, Director, and Consultant Stock Plan (the
Plan) as of February 13, 2008. The Plan provides for both incentive stock options and nonqualified stock options to be granted to employees,
officers, consultants, independent contractors, directors and affiliates of the Company. The board of directors establishes the terms and
conditions of all stock option grants, subject to the Plan and applicable provisions of the Internal Revenue Code. Incentive stock options must be
granted at an exercise price not less than the fair market value of the common stock on the grant date. The options granted to participants owning
more than 10% of the Companys outstanding voting stock must be granted at an exercise price not less than 110% of the fair market value of the common
stock on the grant date. The options expire on the date determined by the board of directors, but may not extend mare than 10 years from the grant
date, while incentive stock options granted to participants owning more than 10% of the Companys outstanding voting stock expire five years from the grant
date. The vesting period for employees is generally over three years. The vesting Period for non-employees is determined based on the services
28
being provided. The maximum number of shares of stock which may be delivered under the plan
shall automatically increase by a number sufficient to cause the number of shares covered by the plan to equal 10% of the total number of shares of stock then
outstanding on a fully diluted basis.
Under ASC Topic 718, the Company estimates the fair value of option awards on the date of
grant using an option pricing model. The grant date fair value is recognized over the option vesting period, the period during which an employee is required to
provide service in exchange for the award. No compensation cost is recognized for equity instruments for which employees do not render the requisite service.
Under these standards, compensation cost for employee cost for employee stock-based awards is based on the estimated grant-date fair value and recognized over
the vesting period of the applicable award on a straight-line basis. As of May 23, 2014, there were options to purchase 5,557 outstanding at an
average exercise price of $20.25 per share.
Stock appreciation rights may be granted either on a stand-alone basis or in conjunction with
all or part of any other stock options granted under the plan. As of May 23, 2014 there were no awards of any stock appreciation rights.
Reports
We are subject to certain reporting requirements and will furnish annual financial reports to
our stockholders, certified by our independent accountants, and will furnish unaudited quarterly financial reports in our quarterly reports filed electronically
with the SEC. All reports and information filed by us can be found at the SEC website, www.sec.gov.
INTEREST OF NAMED EXPERT AND COUNSEL
The Law Offices of Robert L. B. Diener, 56 Laenani Street, Haiku, HI 96708 was retained for
the purpose of preparing this registration statement, rendering the legal opinion, attached as an exhibit hereto, on the validity of the common stock to be
issued pursuant to this Registration Statement and for an opinion letter to the auditor which was required to complete the audit enclosed herein. As payment for
said service, the Law Office of Robert L. B. Diener was paid a total of $2,500.00. The Law Offices of Robert L. B. Diener is not receiving any contingent
interest, fee or shares in the Company.
The Law Office of Robert L. B. Diener may be retained for additional legal services in the
future at fees to be agreed upon.
The financial statements of Vycor Medical, Inc., as provided herein, have been audited by an
independent registered public accounting firm. The audit firm that has provided the audited financials is Paritz & Co., P.A., 15 Warren St., Hackensack NJ
07601. Paritz & Co., P.A. is not receiving any contingent interest, fee or shares in the Company.
INFORMATION WITH RESPECT TO THE REGISTRANT
ORGANIZATIONAL HISTORY
The Company was formed as a limited liability company under the laws of the State of New York on
June 17, 2005 as Vycor Medical LLC. On August 14, 2007, we converted into a Delaware corporation and changed our name to Vycor Medical,
Inc.. The Companys listing went effective on February 2009 and on November 29, 2010 Vycor completed the acquisition of substantially all of the
assets of NovaVision, Inc. (NovaVision) and on January 4, 2012 Vycor, through its wholly-owned NovaVision subsidiary, completed the acquisition of
all the shares of Sight Science Limited (Sight Science), a previous competitor to NovaVision.
BUSINESS OVERVIEW
Vycor is dedicated to providing the medical community with innovative and superior neurosurgical
and neurotherapeutic solutions and operates two distinct business units within the medical industry. Vycor Medical designs, develops and markets medical devices
for use in neurosurgery. NovaVision develops non-invasive, computer-based light stimulation therapies for those suffering from vision loss resulting from
neurological trauma.
Both businesses adopt a minimally or non-invasive approach. Both technologies have strong sales
growth potential, address large potential markets and have the requisite regulatory approvals. The Company has 40 granted patents and a further 15 pending. The
Company leverages joint resources across the divisions to operate in a cost-efficient manner
.
29
In addition to our existing products and products in development we actively seek acquisition,
joint venture and in-licensing opportunities in the medical device field which we believe are complementary, can benefit from our existing infrastructure and
will add shareholder value.
Vycor Medical
Introduction
Vycor Medical designs, develops and markets medical devices for use in
neurosurgery. Vycor Medicals ViewSite Brain Access System (VBAS) is a next generation retraction and access system that was fully
commercialized in early 2010 and is the first significant technological change to brain tissue retraction in over 50 years in contrast to significant
development in most other neuro-surgical technologies. Vycor Medical is ISO 13485:2003 compliant, and VBAS has U.S. FDA 510(k) clearance and CE Marking for
Europe (Class III) for brain and spine surgeries, full regulatory approvals in Australia, Canada, China, Korea and Japan and is seeking or has partial
regulatory approvals in Brazil, India, Russia, Taiwan and Vietnam.
Vycor Medicals Products
VBAS
To access a surgical site in the brain, a surgeon usually needs to
remove part of the skull (craniotomy) and then make an entry incision in the outer protective brain tissue (corticotomy); the soft brain tissue is then parted
(retracted) to access the targeted site. The current standard of care, the blade retractor, utilizes a metal blade retractor to pull the tissue apart; to
maintain the opening the blades are attached to a head frame and parting tension is applied to the tissue. In a typical procedure somewhere more than 2 blades
are used.
Many clinical studies have shown that retractors can cause excessive pressure on brain
tissues, resulting in damage and a prolonged patient recovery. The incidence of contusions (tissue injuries) or infarctions (blockage of blood supply) from
brain retraction is as great as 5-10% in cranial surgeries.
Vycors VBAS is a significant improvement over current technologies for accessing
regions within the brain. A disposable product that can be used with both endoscopic and neuro-navigation systems (IGS), the VBAS includes an introducer and
working channel. Available in multiple sizes, the current series consists of 12 disposable products, offered in four different port (working channel) diameters
of 12mm, 17mm, 21mm, and 28 mm and a choice of three lengths: 3cm, 5cm, and 7cm. The surgeon makes a smaller corticotomy, inserts the clear, elliptical-shaped
VBAS introducer through the brain tissue, removes the introducer and is left with a clear hollow working channel to provide access to the precise location
desired for surgery.
VBAS clinical advantages are supported by a number of leading peer-reviewed articles (see
Peer Review and Other Clinical Studies)
. Clinical benefits cited include: minimally invasive shape and less invasive procedure; resultant reduction of
pressure on the brain; improved visual field; improved working channel; and more accurate target access. Management also believes, from anecdotal surgeon
feedback, that although a disposable product VBAS offers potential cost savings from shorter operating theater time and reduced post-operative recovery time.
The Market For Vycor Medicals VBAS Product
VBAS is used for craniotomy procedures. Based on statistics from the American Association of
Neurological Surgeons (AANS), management estimates 700,000 such procedures were performed in the US in 2012. Of this, management believe approximately 200,000
(28 percent) are addressable by the VBAS range currently, with another 125,000 (total of 325,000 or 46 percent) addressable by an expanded future range.
Management estimates, for the global market, there exists a current addressable market of approximately 1,000,000 procedures with another 600,000 addressable by
an expanded VBAS range.
Competition
The VBAS device is both a brain access system and a retractor and is therefore unique with no
direct competitors. Competitive manufacturers of brain retractors include Cardinal Health (V. Mueller line), Aesculap, Integra Life Science and Codman (Division
of Johnson & Johnson). Nico Corporation has a brain access device specifically designed to work with its Myriad resection and suction product.
30
Sales and Marketing
Domestic
According to the American Board of Neorological Surgery (ABNS), there are approximately 3,500
neurosurgeons in the US, providing a well-defined target audience. Vycor Medicals sales channels are to stocking regional distributors and direct to
hospitals through independent representatives, all of whom have existing relationships with neurosurgeons and provide an experienced and efficient distribution
infrastructure without the need for a large and costly dedicated Vycor regional sales team. The distributors and representatives are supported by Vycor Medical
Sales, Marketing and Customer Service.
Vycor Medical has found that the learning curve is only 1-2 cases for surgeons, who like the
simplicity of design and ease of use after trialing the product. However, Hospital Administration is required to approve the purchase of a new product and
sometimes even a trial or evaluation of the product in the hospital by the neurosurgeon and this is one of the key barriers to the speed of adoption as this
process can take several months.
International Sales
Vycor Medical utilizes select medical device distributors with experience in neurosurgical
devices in their countries or regions. Vycor Medical has regulatory approvals for VBAS in Australia, Canada, China, Europe (Class III), Korea and Japan and is
seeking or has partial regulatory approvals in Russia, India, Vietnam and Taiwan with distribution agreements in place or being sought.
Peer Review and Other Clinical Studies
The publication of clinical papers in neurosurgery journals by surgeon-users of VBAS
regarding their experiences with the products (peer review papers), and the publication of other clinical data, is important for the Company as it continues to
evidence the clinical superiority of VBAS which in turn drives its adoption and accelerates the hospital approval process. During the last 3 years the following
papers were published:
|
|
|
Usage of a Minimally Invasive Tubular Retraction
System for Deep-Seated Tumors in Pediatric Patients in
Journal of Neurosurgery
in May 2011: Pediatrics. Co-authors Pablo Recinos, M.D., of the
Cleveland Clinic and George Jallo, M.D., of Johns Hopkins University conclude that while access to deep-seated, intra-axial tumors is challenging, the
ViewSite™ tubular retractor and frameless neuro navigation facilitated the surgical approach and the combination of these technologies adds to the
surgeons armamentarium to safely approach tumors in deep locations.
|
|
Vycor Viewsite TC: Endoscope-guided Intraparenchimal
Brain Tumor Resection, by Daniel Prevedello, M.D., Director of the Minimally Invasive Cranial Surgery Program at the Ohio State University. Dr Prevedello
reported on a case with a patient taking Avastin®, which delays surgical wound healing. He said the Viewsite TC was essential to the surgery; otherwise, no
procedure could have been performed on the patient.
|
|
Minimally Invasive Trans-Portal Resection of Deep
Intracranial Lesions in
Minimally Invasive Neurosurgery,
February 2011 a Johns Hopkins University paper by lead author A. Quinones Hinojosa. The
authors reported a case series of 9 adult and pediatric patients with a variety of pathologies, including colloid cyst, DNET, papillary pineal tumor, anaplastic
astrocytoma, toxoplasmosis and lymphoma. The locations of the lesions approached included: lateral ventricle, basal ganglia, pulvinar/posterior thalamus and
insular cortex. Post-operative imaging was assessed to determine extent of resection and extent of white matter damage along the surgical trajectory.
Satisfactory resection or biopsy was obtained in all patients. VBAS lends itself well to minimally invasive microsurgical approaches and can be used in
combination with modern navigational systems. The use of navigation permits not only the creation of a smaller craniotomy but also facilitates the creation of a
trajectory that provides efficient and safe means for splitting white fiber tracts, said the authors.
|
|
3D Endoscope-Assisted Transcallosal Approach to the
Third Ventricle Using a Minimally Invasive Tubular Retractor System A Feasibility Study by Alireza Shoakazemi, Alexander I. Evins, Philip E. Stieg,
Antonio Bernardo Published in J Neurol Surg B 2014; 75 - A047. Weill Cornell Medical Center.
Conclusion.
Though some authors have advocated the benefits
of retractorless microsurgical techniques in approaching the third ventricle, the use of routine retractors and their potential complications, in some cases,
cannot be avoided. An increased incidence of cortical damage has been reported in a rat model, wherein retractors were held in place for more than 15 minutes at
a pressure of 20 mmHg. We found the interhemispheric 3D endoscope-assisted trancallosal approach through tubular retractors to be feasible for the management of
pathologies of the third ventricle.
|
|
3D Endoscopic Transtubular Anterior Petrosectomy for
Petroclival Meningiomas: Assessment of Resection in Varying Tumor Volumes Utilizing a Synthetic Tumor Model Alexander I. Evins, Alireza Shoakazemi, Justin
C. Burrell, Rahul Kapoor, Philip E. Stieg, Antonio Bernardo Published J Neurol Surg B 2014; 75 - A036. Weill Cornell
31
Medical Center.
Conclusion.
The
application of 3D endoscopic transtubular anterior transpetrosal approaches in the treatment of medium and large petroclival meningiomas is both feasible and
effective. Despite the demonstrated efficacy on those tumor types, resection of specific giant petroclival meningiomas still necessitate the use of traditional
skull base microsurgical techniques. Further clinical studies are necessary to determine potential clinical complications
|
Manufacturing
Vycor Medical uses sub-contract manufacturers to manufacture, package, label and sterilize
its products. Lacey Manufacturing Company of Bridgeport, Connecticut manufactures 6 of the VBAS 12 different sizes, is FDA-registered and meets ISO standards
and certifications. C&J Industries, Meadville PA (C&J) manufactured the remaining 6 of the VBAS 12 different sizes. The sub-contract
agreement with C&J formally expired in 2014; Vycor Medical holds sufficient inventory for its foreseeable needs and is in discussions with selected
qualified sub-contract manufacturers to replace C&J.
Intellectual Property
Patents
Vycor Medical maintains a portfolio of patent protection on its methods and apparatus for its
Brain and Spine products and technology in the form of issued patents and applications, both domestically and internationally, with a total of 8 granted and 8
pending patents.
Vycor Medicals 8 granted patents are in the China (Brain), Hong Kong (Brain), Russia
(Brain), Japan (Brain and Spine) and US (Brain (2) and Spine).
Vycor Medicals 8 pending patents are in: Canada (Brain, Spine), Europe (Brain, Spine),
India (Brain, Spine), Hong Kong (Spine), US (Navigation Arm).
Trademarks
VYCOR MEDICAL
is a registered trademark and
VIEWSITE
is a common law
trademark.
Vycor Growth Strategy
Vycor Medicals growth strategy is centered around:
1.
Increasing U.S. market penetration
through broader hospital coverage and targeted direct physician
marketing.
Vycor Medicals sales and marketing strategy is to penetrate a well defined target market
of 3,500 neurosurgeons by trade shows, significantly increased direct marketing with VBAS samples and existing clinical data, and through its existing
distributors which it is continually evaluating and upgrading as well as adding additional distributors in regions where it has little to no presence. In
marketing to these hospitals and surgeons, Vycor Medical leads with those neurosurgical procedures where VBAS competitive advantages are most easily
understood deep seated tumors and other complicated deep procedures. The focus is both on adding new hospitals and expanding to additional surgeons in
hospitals where VBAS is already approved and to expand usage to a broader range of procedures. Vycor Medical prioritizes its attention on teaching hospitals,
which not only carry out more relevant procedures but also provide a natural way to drive adoption through the conversion of new surgeons.
2.
Provision of more Clinical and Scientific Data
supporting the products superiority
over the current standard of care blade retractors and to demonstrate the products potential for cost savings.
Clinical and scientific data (in the form of peer reviewed articles, clinical studies and other
reports and case studies) are critical in driving adoption further and faster by demonstrating VBAS' superiority as a minimally invasive access system which
helps VBAS move further up the hospital cost/benefit curve. To this end an animal comparative study is currently underway. This study is intended to demonstrate
greater ease of access, faster surgery time and reduced tissue damage. The second area Vycor Medical will address is MRI compatibility. Increasingly, intra
operative MRI is increasingly being used in neurosurgery, further playing to VBAS' competitive edge over the traditional non MRI-compatible metal blade
retractor. Vycor Medical intends to commission a brief technical study so that VBAS can be formally certified as MRI compatible. Vycor Medical is also aware of
two additional studies in peer-reviewed journals anticipated to be published during 2014 by the Weill Cornell Medical Center, and additional studies are also
underway and should be published during 2014 and 2015.
32
3.
International Market Growth
Vycor Medical utilizes select medical device distributors with experience in neurosurgical
devices in their countries or regions. In Europe, the Company currently only has a limited number of distributors and is only now turning its focus to this
geographic region. VBAS has full regulatory approvals in Australia, Canada, China, Europe (EU Class III), Korea and Japan and is seeking or has partial
regulatory approvals in Brazil, India, Russia, Taiwan and Vietnam. Vycor Medical plans on focusing on the international markets and is actively pursuing new
distribution agreements.
4
. New Product Development
New Product Development is targeted at both driving the use of its existing VBAS product range
through ancillaries that will facilitate the products use and through new product extensions to broaden VBAS applicability to procedures currently not
addressed by the existing product line.
Vycor Medical has launched in the US a universal non-disposable extension arm to VBAS, as a
result of surgeon feedback, which further increases the ease of use of its disposable VBAS product and, management believes, will augment VBAS adoption.
Vycor Medical has prototyped and is now implementing manufacturing of two new smaller VBAS
devices that will facilitate endoscopic work within the ventricles including the placement of catheters, with particular relevance for the pediatric
neurosurgical market. Vycor Medical developed this with a leading neurosurgeon and anticipates the product being available by the end of 2014.
Vycor Medical is also working on a new set of VBAS devices that will be targeted at being
completely compatible with selected Image Guided Systems. Management strongly believes that the existing VBAS rigid structure lends itself well to being
incorporated into the increasing trend of IGS surgery and anticipates having compatible devices finalized for production during 2014.
NovaVision, Inc.
Introduction
NovaVision provides non-invasive, computer-based vision solutions targeted
at a substantial and largely un-addressed market of people who have lost their sight as a result of Stroke or Traumatic Brain Injury (neurological brain
damage). NovaVision addresses a significant target market, estimated at approximately $2 billion in the U.S. and over $13 billion globally.
NovaVision has a family of therapies that both restore lost vision and address other
neurologically-induced vision issues:
·
Restoration of vision: NovaVisions VRT and Sight Sciences Neuro-Eye Therapy (NeET), aim
to improve visual sensitivity. VRT delivers a series of light stimuli along the border of the patients visual field loss. These programmed light sequences
stimulate the border zone between the seeing and blind visual fields, repetitively challenging the visual cortex in the border zone with
multiple stimuli over the course of time. NeET targets deep within the blind area by repeated stimulation, allowing patients to detect objects within the blind
field.
·
Compensation and Re-training: NeuroEyeCoach™ provides a complementary therapy to VRT and NeET,
which re-trains ability of a patient to move their eyes, re-integrate left and right vision and to make the most of their remaining visual field.
NovaVision operates in the US through our wholly-owned subsidiary, NovaVision, Inc., in Germany
through our wholly-owned subsidiary, NovaVision GmbH and in the UK through our wholly-owned subsidiary, Sight Science Limited.
NovaVisions VRT is the only medical device aimed at the restoration of vision for
neurologically induced vision loss which has FDA 510(k) clearance to be marketed in the U.S; VRT and NeET both have CE Marking for the EU and
NeuroEyeCoach™ is registered in the US as a Class I 510(k) exempt device. NovaVision has 32 granted and 7 pending patents worldwide.
33
NovaVision’s Products
VRT and NeET
VRT and NeET are aimed at those suffering from vision loss resulting from neurological trauma
such as stroke and traumatic brain injury (TBI). It is estimated that approximately 16% of these patients experience a visual field deficit, reducing mobility
and other activities of daily living. NovaVisions VRT and NeET target market is this subset of patients who have suffered a visual field deficit.
Both VRT and NeET work on the basis that repeated stimulation of the blind or transition areas by
either bright patches of light (VRT) or the specific spatial patterns (NeET) which can lead to increases in sensitivity of the blind areas. Patients progress
after VRT appears to be initiated at the blind and sighted borders whereas NeET results in changes deep within the blind field. Both therapies are able to
demonstrate improvements in both visual sensitivity and activities of daily living. The Company believes that these therapies are complementary.
VRT and NeET are patient-specific diagnostic and therapeutic platforms with extensive clinical
data supporting their ability to increase a patients visual field. The diagnostic algorithm first maps the visual field and defines the areas of defect in
patients suffering vision loss. The therapeutic algorithm is then specifically designed for each patient based upon the results of the diagnostic program and it
repetitively challenges the visual cortex with thousands of stimuli over the course of time. The therapies are delivered through a computer device in the
patients home and are generally performed over a four to six month period, twice a day for approximately an hour total, six days a week.
With VRT therapy, the patient first focuses on a fixation point on a display screen. Then, a
series of light stimuli are presented along the border of the patients visual field loss. These programmed light sequences stimulate the border zone
between the seeing and blind visual fields, repetitively challenging the visual cortex in the border zone with thousands of stimuli over
the course of time. With NeET, the patient responds to the images that appear on the screen, initially in the border area of the patients visual
field loss and over time deeper within the damaged field of vision.
Vycor acquired NovaVision at the end of 2010. While its VRT was clinically supported to be
effective, was underpinned by 15 years of clinical research and 20 studies evidencing that 70% of patients benefited from the therapy further development was
required in order: to ensure that all patients received benefit; to make it cost effective and affordable; and to make it scalable. As not all patients benefit
from VRT, management concluded that a new complementary eye training therapy should be introduced into the NovaVision therapy suite to provide broader benefits
to patients than the delivery of VRT on its own, and has recently soft-launched NeuroEyeCoach™ in the U.S.
NeuroEyeCoach™
NovaVision’s recently soft-launched NeuroEyeCoach™ in the U.S. This is also a
computer based program providing eye-movement training to those who have suffered a visual field loss as a result of neurological.
The program is supported by more than four decades of scientific findings and was developed
as collaboration between NovaVision and Josef Zihl, a NovaVision Scientific Advisor who is a world thought leader in saccadic training and the pioneer of this
computer based training technique. The program is designed to result in a meaningful improvement in the patients visual search performance resulting in
improvements in their navigation and object finding skills. Given that NeuroEyeCoach™ addresses the patients difficulty with their eye movements and their
ability to integrate visual information while VRT and NeET focuses on the restoration of lost vision the two therapy types are highly complementary.
NeuroEyeCoach™ is delivered to patients’ computers in their homes and also provided
as a clinic-based version to enable healthcare professionals to provide the therapy to patients under supervision. NovaVision has commenced marketing
NeuroEyeCoach™ as a standalone therapy; in addition to benefitting patients in VRT’s target market, those suffering non-permanent defects or those
otherwise unsuited to VRT can benefit from NeuroEyeCoach™. Upon completion of the VRT web based development it will be marketed with NeuroEyeCoach™
in one therapy suite providing broad benefits to all patients.
The Market For NovaVision’s Therapies
The market for NovaVision’s therapies comprises those suffering from vision loss resulting
from neurological trauma such as Stroke and Traumatic Brain Injury (TBI). The U.S. Centers for Disease Control (CDC) estimates there are 8 million Americans who
have previously had a stroke incident, with 740,000 additional cases occurring annually. Additionally, approximately 5.3 million Americans live with long-term
effects of a TBI. Based on published reports of industry specialists, A. Pambakian and C. Kennard, it is estimated that approximately 30% experience some visual
impediment and 16% of these patients experience a permanent visual field deficit, reducing mobility and other activities of daily living. The target market for
NeET and VRT is this 16% subset of patients who have suffered a
34
permanent visual field deficit. Management estimates that the addressable target market is
approximately 1.5 million people in the US, approximately 1.4 million people in Europe and approximately 6.4 million people throughout the rest of the world.
The market potential is further increased by the introduction of NeuroEyeCoach™ which addresses all 30% of patients who experience visual impediments and
therefore adds an additional 3.6m people in the US and Europe and 8m in the rest of the world.
Competition
NovaVision provides restitution or restoration therapies (with VRT and NeET) and compensation or
saccadic therapies (with NeuroEyeCoach™) for those suffering neurologically-induced vision loss. The other therapy type for this condition is substitution
(optical aids such as prisms) and is not considered by NovaVision as competition.
In restitution, competition has been reduced through NovaVisions acquisition of Sight
Science and really only leaves two small companies, Teltra and Visiontrainer in Germany. Within compensation, competitors include RevitalVision, PositScience,
Rehacom and NVT Systems.
Clinical Data
VRT
NovaVision has accumulated significant amounts of clinical data as a result of company-sponsored
trials as well as studies conducted by independent third parties, of which some of the key findings can be summarized as:
|
|
|
|
|
Approximately 70% of patients experience positive outcome
reflected by an increase in their visual field and studies have indicated an average increase of 4.9 degrees (Mueller I, Mast H, Sabel BA (2007), Romano JG
2008).
|
|
|
Elapsed time since injury does not seem to impact VRT and NeET
therapies success. Therefore, a large historical backlog of patients can potentially be treated (Romano JG, Schulz P, Kenkel S, Todd DP (2008)).
|
|
|
Improvements are permanent and do not appear to be age or
gender dependent.
|
|
|
Age at the onset of the injury is not a critical factor,
allowing access to the therapy by both young and older adults with brain injuries (Romano JG, Schulz P, Kenkel S, Todd DP (2008)).
|
NeuroEyeCoach
The PC-based treatment approach was originally developed by Prof. Zihl (1988, 1990) and has since
been used with various modifications in 14 studies on a total of 591 patients with homonymous visual field loss and persistent visual disabilities.
The main outcome is a significant improvement in visual search performance accompanied by more
efficient oculomotor strategies, and a reduction in visual disability as assessed with standardized questionnaires and behavioral measures. The efficacy of this
treatment approach for the improvement of visual overview and visual exploration is superior to practice with reading (Schuett et al., 2012), non-specific
visual training (Roth et al., 2009), standard occupational therapy (Mödden et al., 2012) or counseling with regards to coping strategies (Zihl, 2011).
Importantly, time since brain injury (Zihl, 2011) and age of hemianopic patients (Schuett & Zihl, 2012) do not play a significant role for the treatment
effect. In conclusion, there is convincing scientific empirical evidence for the efficacy of the visual search treatment method. It is important to note, that
visual field borders did not change after the treatment, indicating that visual search training represents a compensatory technique and not a restorative
approach.
Intellectual Property
Patents
NovaVision maintains a portfolio of patent protection on its methods and apparatus in the form of
issued patents and applications, both domestically and internationally, with a total of 32 granted and 8 pending patents (including Sight Science).
NovaVisions 32 granted patents are in the U.S. (13), Canada (3), Europe (7), Australia (2),
China (2), Hong Kong (1), Singapore (1), India (1) and Japan (2).
NovaVisions 7 pending patents are in Canada (2) and Europe (5).
35
Trademarks
NovaVision maintains a portfolio of registered trademarks for
NOVAVISION, NOVAVISION VRT
and
VRT VISION RESTORATION THERAPY
amongst others, both in the US and internationally.
NovaVisions Growth Strategy
Prior to Vycors acquisition in late 2010, NovaVision previous
management had already invested more than $50 million largely on developing the businesss core VRT therapy, gaining significant patent protection and
validating the therapy through significant clinical research.
While its VRT was clinically supported to be effective, being underpinned by 15 years of clinical
research and 20 studies evidencing that 70% of patients benefited from the therapy, further development was required in order to: ensure that all patients
received a benefit; to make it cost effective and affordable; and to make it scalable.
Following the acquisition, Vycor put in place a world class Scientific Advisory Board and
acquired Sight Science in the UK, NovaVisions only sizeable competitor, thereby also gaining a highly regarded Chief Scientific Officer. Leveraging this
scientific team, NovaVisions strategy is centered around driving the adoption of its therapies, through:
1. Reduced Cost and Greater scalability;
enabled by a completely new therapy delivery
mechanism moving away from hardware based to an asset light software solution allowing significant cost savings, which will be passed onto the patients. This
different delivery mechanism and significant business process streamlining of currently largely manual tasks will enable NovaVision to provide an affordable and
much more scalable therapy and thus be in a position to service a much larger number of patients.
2. Introduction of a new therapy module
into the NovaVisions overall visual
rehabilitation therapy regime that will provide additional functional benefits to patients who undergo the regime. This new therapy program,
NeuroEyeCoach™, is a saccadic training program which is highly complementary to VRT and will ensure that patients will receive greater benefit from the
overall NovaVision therapy regime. NeuroEyeCoach™ is internet-delivered and is targeted at the same patients as VRT. Stroke patients, in addition to
losing their sight, typically also have difficulty moving their eyes and integrating visual information. These conditions lead patients to need specific
re-training to make effective use of their eyes and get the most out of their remaining vision. NeuroEyeCoach™ will be sold as a standalone therapy; in
addition to benefitting VRT patients, those suffering non-permanent defects or those otherwise unsuited to VRT can benefit from NeuroEyeCoach™. Upon
completion of the VRT web based development it will be marketed with NeuroEyeCoach™ in one therapy suite providing broader benefit to patients.
3. New Potential Licensing model targeted at Rehabilitation Centers
. Management is
also in the advanced stages of exploring a licensing model under which NovaVision would license a diagnostic-only VRT device to a rehabilitation center for a
monthly fee. The center, be it in-patient or out-patient, would be able to efficiently screen its patients on their own for visual field deficits. NovaVision
would receive licensing fees and benefit from incremental patient flow from center referrals.
OTHER
Employees
We currently have 17 employees.
Websites
The Company operates websites at
www.vycormedical.com,
www.novavision.com, www.neuroeyecoach.com and www.sightscience.com
36
LEGAL PROCEEDINGS
We are subject from time to time to litigation, claims and suits arising in the ordinary
course of business. As of May 23, 2014, we were not a party to any material litigation, claim or suit whose outcome could have a material effect on our
financial statements.
DESCRIPTION OF PROPERTY
The Company leases approximately 10,000 sq. ft located at 6401 Congress Ave., Suite 140, Boca
Raton, FL 33487 from Catexor Limited Partnership for a gross rent of $14,260 plus sales tax per month. The term of the lease is 5 years and 6 months
terminating July 2017.
37
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operation for the years
ended December 31, 2013 and 2012 and the three month periods ended March 31, 2014 and 2013 should be read in conjunction with the financial statements and the
notes to those statements that are included elsewhere in this report. Our discussion includes forward-looking statements based upon current expectations that
involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially
from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth under the Risk Factors,
Cautionary Notice Regarding Forward-Looking Statements and Our Business sections in this Form S-1. We use words such as
anticipate, estimate, plan, project, continuing, ongoing, expect,
believe, intend, may, will, should, could, and similar expressions to identify
forward-looking statements.
Critical Accounting Policies and Estimates
Uses of estimates in the preparation of financial statements
The preparation of consolidated financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and
accompanying notes. Actual results could differ from those estimated. To the extent managements estimates prove to be incorrect, financial
results for future periods may be adversely affected. Significant estimates and assumptions contained in the accompanying consolidated financial
statements include managements estimate of the allowance for uncollectible accounts receivable, amortization of intangible assets, and the fair values of
options and warrant included in the determination of debt discounts and share based compensation.
Cash and cash equivalents
The Company maintains cash balances at various financial institutions. Accounts at each
institution are insured by the Federal Deposit Insurance Corporation up to $250,000. Cash balances may at times exceed the FDIC insured limits. Cash also
includes a US investment account in a money market backed by government securities up to 105% of the account balance. The Company considers all highly liquid
investments with maturity of three months or less when purchased to be cash equivalents. Included within cash are deposits paid by patients, held by
the Company until the patient returns the VRT device at the end of therapy. At December 31, 2013 and 2012 patient deposits amounted to $25,467 and $35,000,
respectively, and are reserved against in Other Current Liabilities.
Fixed assets
The Company records fixed assets at cost and calculates depreciation using the straight-line
method over the estimated useful life of the assets, which is estimated to be between three and seven years. Maintenance, repairs and minor renewals are charged
to expense when incurred. Replacements and major renewals are capitalized
Income taxes
The Company accounts for income taxes in accordance with the current authoritative guidance.
Deferred income tax assets and liabilities are determined based upon differences between financial reporting and tax basis of assets and liabilities and
are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are
established, when it is more likely than not that such benefit will not be realized.
Patents and Other Intangible Assets
The Company capitalizes legal and related costs associated with the establishment and enhancement
of patents for its products once patents have been applied for. Costs associated with the development of the patented item or processes are charged to research
and development costs as incurred. The capitalized costs are amortized over the life of the
38
patent. The Company reviews intangible assets on an annual in accordance with the authoritative
guidance. Trademarks have an indefinite life and are reviewed annually by management for impairment in accordance with the authoritative guidance.
Software Development Costs
The authoritative accounting guidance
requires software development costs to be
capitalized upon completion of the preliminary project stage. Accordingly, direct internal and external costs associated with the development of the
features and functionality of the Companys software, incurred during the application development stage, are capitalized and amortized using the
straight-line method of the estimated life of five years.
Revenue Recognition
Vycor Medical generates revenue from the sale of its surgical access system to hospitals and
other medical professionals. Vycor Medical records revenue when a completed contract for the sale exists, the product is invoiced and shipped to the
customer. Vycor Medical does provide for product returns or warranty costs.
NovaVision generates revenues from various programs, therapy services and other sources such as
license sales. Therapy services revenues represent fees from NovaVisions vision restoration therapy software, diagnostic software, medical devices, clinic
set up and training fees, and the professional and support services associated with the therapy. NovaVision recognizes revenue for providing the vision
restoration therapy as the Companys work effort is expended. NovaVision provides vision restoration therapy directly to patients. The typical vision
restoration therapy consists of six modules, performed on average over 6 months in the U.S. and U.K. and 10 months in Germany. A patient contract comprises
set-up fees and monthly therapy fees. Set-up fees are recognized at the outset of the contract and therapy revenue is recognized ratably over the therapy
period. Patient therapy is restricted to being completed by a patient within a specified time frame.
Deferred revenue results from patients paying for the therapy in advance of receiving the
therapy.
Accounts Receivable
The Companys accounts receivable are due from the hospitals and distributors in the case of
Vycor Medical, and from patients directly therapy or physicians for diagnostic products in the case of NovaVision. Accounts receivable are due once
products have been delivered or at the time the therapy is initiated; however, for NovaVision therapy patients sometimes credit is extended through various
payment plans based on individual financial conditions, generally not to exceed the 9 or 10 month therapy period. The outstanding balances are stated net
of an allowance for doubtful accounts. The Company determines its allowance by considering a number of factors, including the length of time accounts
receivable are past due, and the customers ability to pay its obligations. The Company writes off accounts receivable when they become
uncollectible.
Inventory
Inventories are comprised of Vycor Medical VBAS devices, components ancillary to
NovaVisions medical device provided to patients and centers and diagnostic products, and are stated at the lower of cost or market, determined under the
first-in, first-out method. The inventory is charged to cost of revenue at the time that a device is shipped to a customer or patient.
Foreign Currency
The Euro is the local currency of the country in which NovaVision GmbH conducts its operations
and is considered the functional currency of this entity; the GB Pound is the local currency of the country in which Sight Science Limited conducts its
operations and is considered the functional currency of this entity. All balance sheet amounts are translated to U.S. dollars using the U.S. exchange rate
at the balance sheet date except for the equity section which is translated at historical rates. Operating statement amounts are translated using an
average exchange rate for the period of operations. Foreign currency translation effects are accumulated as part of the accumulated other comprehensive
income (loss) and included in shareholders (deficit) in the accompanying Consolidated Balance Sheet.
Educational marketing and advertising expenses
The Company may incur costs for the education of customers on the uses and benefits of its
products. The Company will include education, marketing and advertising expense as a component of selling, general and administrative costs as such costs are
incurred.
39
RESULTS OF OPERATIONS
Comparison of the Year Ended December 31, 2013 to the Year Ended December 31, 2012
Revenue and Gross Margin:
|
|
|
|
|
2013
|
2012
|
% Change
|
Revenue:
|
|
|
|
Vycor Medical
|
$724,367
|
$770,676
|
(6)%
|
NovaVision
|
$365,007
|
$434,587
|
(16)%
|
Total Revenue
|
$1,089,374
|
$1,205,263
|
(10)%
|
Gross Profit
|
|
|
|
Vycor Medical
|
$628,839
|
$668,729
|
(6)%
|
NovaVision
|
$306,703
|
$357,004
|
(14)%
|
Total Gross Profit
|
$935,542
|
$1,025,733
|
(9)%
|
Vycor Medical recorded revenue of $724,367 from the sale of its products for the year ended
December 31, 2013, a decrease of $46,309 from 2012. Management believes that a decline in sales during February 2013 may have partially been the result of the
posting by the FDA in late January 2013 of a Class 1 classification to the recall which the Company had completed in November 2012, and which created some
short-term customer instability. Notwithstanding, for the period commencing March 1, 2013 and continuing through December 2013, Vycor Medical's sales returned
to pre-February 2013 levels. Gross margin of 87% was achieved in 2013 and 2012.
NovaVision recorded revenues of $365,007 for the year ended December 31, 2013, a decrease of
$69,581 from 2012, and gross margin of 82%, compared to 87% for 2012. $10,730 of the revenue decrease was due to the sale of HMP-200 units in 2012, a legacy
pre-acquisition product; NovaVision has ceased sales of this unit pending further development. NovaVisions therapy suite has been undergoing significant
development to: substantially reduce costs of delivery; as a result drive down the price of VRT therapy to make it affordable; streamline business processes to
make the therapy scalable; add a new saccadic program to broaden the range of benefits to patients from the therapy suite. As a result the Company is not
intensively marketing its existing VRT program model and this, together with NovaVisions intense focus on development particularly in the second half of
2013, impacted revenues.
Research and Development Expense:
Research and development expenses were $53,451 in 2013 compared to $126,042 for 2012. The
expense reduction partly reflects the capitalization of costs related to NeuroEyeCoach once it passed commercial feasibility.
General and Administrative Expenses:
General and administrative expenses decreased by $599,963 to $2,813,041 in 2013 from
$3,413,004 in 2012. Included within General and Administrative Expenses are non-cash charges for share based compensation as the result of amortizing employee
and non-employee shares, warrants and options which have been issued by the Company over various periods. The charge for 2013 was $450,447, an increase of
$153,443 over $297,004 in 2012. Also included within General and Administrative Expenses are Sales Commissions, which increased by $15,849 to $90,552 reflecting
higher levels of sales.
The remaining General and Administrative decrease of $769,255 reflects:
reduced investor relations, public relations and related costs, including video production ($100,239); reduced scientific
advisory costs, in part due to capitalization
costs related to NeuroEyeCoach once it passed commercial feasibility ($96,529);
reduced professional and consulting fees ($32,848); reduced legal costs including patent ($25,753); reduced premises costs
($71,363); reduced payroll costs ($382,071); reduced sales, marketing and travel costs ($65,741); and increased other costs ($5,289). The reduced payroll cost
is as a result of the outsourcing of software development activities, the reassignment of executive responsibilities and general rationalization and staffing
efficiency improvements
.
40
Interest Expense:
Interest comprises expense on the Companys debt and insurance policy financing. Related
Party Interest expense for 2013 increased by $44,132
to $131,400 from $87,268
for 2012. Other Interest expense
for 2013 increased by $9,234
to $59,897 from $50,663
for 2012.
.
Liquidity and Capital Resources
Liquidity
The following table shows cash flow and liquidity data for the periods ended December 31, 2013 and December
31, 2012:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2013
|
|
|
|
December 31,
2012
|
|
|
|
$
Change
|
|
Cash
|
|
$
|
31,303
|
|
|
$
|
59,821
|
|
|
$
|
(28,518
|
)
|
Accounts receivable, inventory and other current assets
|
|
$
|
627,649
|
|
|
$
|
863,957
|
|
|
$
|
(236.308
|
)
|
Total current liabilities
|
|
$
|
(5,430,493
|
)
|
|
$
|
(4,018,810
|
)
|
|
$
|
(1,411,684
|
)
|
Working capital (deficit)
|
|
$
|
(4,771,541
|
)
|
|
$
|
(3,095,032
|
)
|
|
$
|
(1,676,510
|
)
|
Cash provided by financing activities
|
|
$
|
1,089,071
|
|
|
$
|
728,368
|
|
|
$
|
360,703
|
|
As of December 31, 2013 we had $31,303 cash, a working capital deficit of $4,771,541 and an
accumulated deficit of $17,032,405. The Stockholders deficit at December 31, 2013 was $3,315,243, compared to a deficit of $1,457,649 at December 31,
2012, a change of $1,857,594. Debt at December 31, 2013 was $2,951,742 compared to $2,195,502 at December 31, 2012.
Comparison of the Three Months Ended March 31, 2014 to the Three Months Ended March 31, 2013
Revenue and Gross Margin:
|
|
|
|
|
|
|
|
|
2014
|
|
2013
|
|
%
Change
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Vycor Medical
|
|
$
|
263,711
|
|
|
$
|
130,665
|
|
|
|
102
|
%
|
NovaVision
|
|
|
94,411
|
|
|
|
101,009
|
|
|
|
(7
|
)%
|
Total Revenue
|
|
$
|
358,122
|
|
|
$
|
231,674
|
|
|
|
55
|
%
|
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
Vycor Medical
|
|
$
|
233,408
|
|
|
$
|
116,279
|
|
|
|
101
|
%
|
NovaVision
|
|
|
81,757
|
|
|
|
85,377
|
|
|
|
(4
|
)%
|
Total Gross Profit
|
|
$
|
315,165
|
|
|
$
|
201,656
|
|
|
|
56
|
%
|
Vycor Medical recorded revenue of $263,711 from the sale of its products in for the three
months ended March 31, 2014, an increase of $133,046, or 102%, over the same period in 2013, reflecting increased activity in the US and internationally. Gross
margin of 89% was achieved in both 2014 and 2013.
NovaVision recorded revenues of $94,411 for the three months ended March 31, 2014, a decrease
of $6,598 over the same period in 2013, and gross margin of 87%, compared to 85% for the same period in 2013. NovaVisions therapy suite has been
undergoing significant development to: substantially reduce costs of delivery; as a result drive down the price of VRT therapy to make it affordable; streamline
business processes to make the therapy scalable; add a new
41
saccadic program to broaden the range of benefits to patients from the therapy suite. As a
result the Company is not intensively marketing its existing VRT program model and this, together with NovaVisions intense focus on development
particularly, impacted revenues.
Research and Development Expense:
Research and development (R&D) expenses were $15,356 for the three months
ended March 31, 2014, as compared to $31,350 for the same period in 2013. The expense reduction partly reflects the capitalization of costs related to
NeuroEyeCoach and VRT. Capitalized software development costs for the three months ended March 31, 2014 and 2013 were $29,633 and $0, respectively. During the
period the Companys VRT 7.0 program completed the preliminary project stage, following which there was a capitalization of $8,171 of software development
costs. Additional costs of $21,463 were capitalized for the Companys NeuroEyeCoach program prior to being brought into service in March 2014 with a total
capitalized value of $119,106.
General and Administrative Expenses:
General and administrative expenses increased by $514,594 to $1,198,252
for the three months ended
March 31,
2014 from $683,658 for the same period in 2013. Included within General
and Administrative Expenses are non-cash charges for share based compensation as the result of amortizing employee and non-employee shares, warrants and options
which have been issued by the Company over various periods. The charge for the three months ended
March 31,
2014 was $168,655, an increase of $80,530 over $88,125 in 2013. Also included within General and Administrative Expenses are Sales Commissions, which increased
by $18,718 to $46,383. The remaining General and Administrative expenses increased by $415,346 from $567,868 to $983,214, of which the Offering costs
comprised $444,539.
An analysis of the change in cash and non-cash G&A is shown in the
table below:
|
|
|
|
Cash G&A
|
Non-Cash G&A
|
Offering costs
|
$444,539
|
$
-
|
Investor relations costs
|
(790)
|
26,532
|
Board, financial and scientific advisory
|
(131,167)
|
53,998
|
Legal, professional and other consulting
|
49,338
|
-
|
Sales, marketing and travel
|
19,075
|
-
|
Payroll
|
16,260
|
-
|
Other
|
18,091
|
-
|
Total change
|
$415,346
|
$80,530
|
Interest Expense:
Interest comprises expense on the Companys debt and insurance policy financing. Related
Party Interest expense for the three months ended March 31, 2014 increased by $4,862
to $33,829 from $28,867
for 2013. Other Interest expense for 2014 increased by $368
to $14,294 from $13,926
for 2013.
42
Liquidity and Capital Resources
Liquidity
The following table shows cash flow and liquidity data for the periods ended March 31, 2014
and December 31, 2013:
|
|
|
|
|
March 31,
2014
|
December 31,
2013
|
$
Change
|
Cash
|
$2,707,089
|
$31,303
|
$2,675,786
|
Accounts receivable, inventory and other current assets
|
$755,428
|
$627,649
|
$127,779
|
Total current liabilities
|
$(2,710,183)
|
$(5,430,493)
|
$2,720,310
|
Working capital/(deficit)
|
$752,334
|
$(4,771,541)
|
$5,523,875
|
Cash provided by financing activities
|
$3,845,223
|
$1,089,071
|
$2,756,152
|
In January to March 2014 the Company held four separate closings (the Closings)
of the sale of $4,070,140 in Units under the Private Placement. These Closings raised net proceeds, after expenses, of $3,638,651. As of March 31, 2014 we had
$2,707,089 cash, working capital of $752,334 and an accumulated deficit of
$17,820,415. Total Stockholders Deficit at March 31, 2014 was $247,332. Total current debt at March 31, 2014, included in working capital above, was
$328,338. Long-term debt at March 2014 was $2,398,487.
Effective May 15, 2014 the Company and the Investors entered into the Waivers under which the
investors agreed to waive their anti-dilution rights in consideration of the Companys agreement not to sell any securities at a price below $2.05 within
the same one-year period (described in more detail in
Description of the Securities To Be Offered
above). As a result of the Waivers received as of May 23, 2014 the Company is no longer required
to record the Series A Warrants and Placement Agent Warrants (“Warrants”) as a derivative liability in respect of the
actual number of Warrants for which the Waivers have been executed. On an adjusted basis, taking received Waivers as of May 23,
2014 into account, as of March 31, 2014 Working Capital was $2,217,260 and total Stockholders’ Equity was $1,217,595.
On April 25, 2014 the Company held a final closing of the Private Placement of $929,860 in
Units raising net proceeds of $837,190 which was added to adjusted Working Capital and adjusted Shareholders Equity.
Off-Balance Sheet Arrangements
As of December 31, 2013 and March 31, 2014, we had no off-balance sheet arrangements.
Seasonality
Our operating results are not affected by seasonality.
Inflation
Our business and operating results are not affected in any material way by inflation.
Critical Accounting Policies
The Securities and Exchange Commission issued Financial Reporting Release No. 60,
"Cautionary Advice Regarding Disclosure About Critical Accounting Policies" suggesting that companies provide additional disclosure and commentary on
their most critical accounting policies. In Financial Reporting Release No. 60, the Securities and Exchange Commission has defined the most critical
accounting policies as the ones that are most important to the portrayal of a company's financial condition and operating results, and require management to
make its most difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. See Uses of
estimates in the preparation of financial statements
above.
CHANGES AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Since inception until the present time, the principal independent accounting firm for the
Company has not resigned, declined to stand for reelection or been dismissed. We have no disagreements with our independent registered public accounting firm on
any matter of accounting principles or with any financial statement disclosures.
43
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
Our Directors and Executive Officers
Set forth below is certain biographical information concerning our current
executive officers and directors. We currently have two executive officers as described below.
|
|
|
|
|
Directors and Executive Officers
|
|
Position/Title
|
|
Age
|
Peter C. Zachariou
|
|
Chief Executive Officer and a
Director
|
|
52
|
David Marc Cantor
|
|
President and a Director
|
|
47
|
Adrian Christopher Liddell
|
|
Chairman of the Board and a
Director
|
|
55
|
Steven Girgenti
|
|
Director
|
|
68
|
Oscar Bronsther, M.D.
|
|
Director
|
|
61
|
Lowell Rush
|
|
Director
|
|
57
|
Pascale Mangiardi
|
|
Director
|
|
41
|
Peter C. Zachariou,
52, was appointed a
Director of the Company in May 2010, Executive Vice President in September 2010 and Chief Executive Officer on January 2, 2014. He is an investment manager for
Fountainhead Capital Management Limited, an investment company based in Jersey, Channel Islands, which invests in, raises capital for and provides strategic
advice to growth companies in healthcare and other sectors. For the past 20 years, Mr. Zachariou has been an active investor in a variety of companies and
industries, both public and private, specializing in workouts and capital formation. Mr. Zachariou's investments and activities have predominantly been in
U.S. emerging and growth companies across a broad range of industry sectors. He has also been proprietor and operator of several businesses in the U.K.
and U.S. in the manufacturing, retail and leisure industries.
David Marc Cantor,
47, has been President of
the Company since September 2010 and a Director since January 2010. He is an investment manager of Fountainhead Capital Management Limited, an investment
company based in Jersey, Channel Islands, which invests in, raises capital for and provides strategic advice to growth companies across a broad range of
sectors. Mr. Cantor has over 22 years experience in Investment Banking with a focus on Mergers and Acquisitions and Equity Capital Raisings. Prior to
Fountainhead from 2001 2005 he was at Citigroup Capital Markets where he was Co-head of its European Business Development Group and subsequently European
Head of its Diversified Industrials and Aerospace activities. Prior to Citigroup he was a Managing Director in M&A at Donaldson Lufkin & Jenrette and
worked at Lehman Brothers both in New York and London in both the Equity Capital and M&A groups. Mr. Cantor has a BSc with Honours from City Business
School, London.
Adrian Christopher Liddell,
55, has been
Chairman of the Board and a Director of the Company since January 2010, and serves as the Companys CFO. He is an advisor to Fountainhead Capital
Management Limited, an investment company based in Jersey, Channel Islands, which invests in, raises capital for and provides strategic advice to growth
companies in healthcare and other sectors. Mr. Liddell has 30 years of strategic, corporate and financial advisory and company investment. From 2003-2006, Mr.
Liddell was an investment advisor at Phoenix Equity Partners, a European private equity fund. From 1998 to 2003, Mr. Liddell served as Managing Director,
Mergers & Acquisitions at Donaldson Lufkin & Jenrette and then Citigroup in London. From 1984 to 1998, Mr. Liddell held various positions at Samuel
Montagu & Co, Lehman Brothers and Erik Penser Corporate Finance in London. Mr. Liddell qualified as a Chartered Accountant in 1984 and holds an MA from
Christs College, Cambridge University.
Steven Girgenti
, 68, has been a director since November 2008 and
is Chairman of the Nominating and Governance Committee and of the Compensation Committee. He is presently the Managing Partner of Medi-Pharm Consulting,
LLC providing strategic services to a number of medical device, pharmaceutical and diagnostic businesses. Steve was formerly President, CEO, Director
and Co-Founder of DermWorx, a specialty pharmaceutical company dedicated to solutions for dermatological conditions. Steve was also the Worldwide Chairman of
Ogilvy Healthworld, a leading global healthcare communications network with 55 offices in 36 countries. The network has more than 1,000 brand assignments
from nearly 200 clients worldwide, providing strategic marketing and communications services to many of the world's leading healthcare companies. Mr.
Girgenti founded Healthworld in
44
1986 and, under his leadership, the company made numerous acquisitions to expand and
diversify the business. Healthworld went public in 1997. In 1998, and again in 1999, Business Week named Healthworld one of the "Best Small
Corporations in America". In 1999, Forbes listed Healthworld as one of the "200 Best Small Companies". Mr. Girgenti was
recognized as "Entrepreneur of the Year" by NASDAQ in 1999, and was named Med Ad News' first "Medical Advertising Man of the Year" in
2000. In 2010 he was inducted into the Medical Advertising Hall of Fame. In addition to Vycor Medical, Mr. Girgenti is a Director of bioAffinity
Technologies, Inc. and has served as a Director of Burren Pharmaceuticals and Pharmacon International. He is also Vice Chairman of the Board of Governors
for the Mt. Sinai Hospital Prostate Disease and Research Center in New York City, and is on the Board of Directors for Jack Martin Fund, a Mt. Sinai Hospital
affiliated charitable organization devoted to pediatric oncology research. He graduated from Columbia University and has worked in the pharmaceutical
industry since 1968 for companies such as Bristol-Myers Squibb, Carter Wallace and DuPont, as well as advertising agencies that specialize in healthcare. During
his career, Steve has held positions in marketing research, product management, new product planning and commercial development.
Oscar Bronsther, M.D., F.A.C.S,
61, has been a director since
November 2011. Dr. Bronsther is Chief Executive Officer of MetaStat, Inc. (OTCBB: MTST), a development stage life sciences company that develops and
commercializes diagnostic products and novel therapeutics for the early and reliable prediction and treatment of systemic metastasisis. Dr Bronsther is also
currently Clinical Professor at George Washington University, Washington, DC and has served in that capacity since 2002. He had previously served as an
Associate Professor at the University of Rochester, Rochester, NY (1994-2001), University of Pittsburgh, Pittsburgh, PA (1989-1994) and University of California
San Diego (1984), and Chairman, Section of General Surgery at Inova Fairfax Hospital. Since 2002, he has served as a Board Member, National Board Member
and Director of Transplant Services of Kaiser Permanente Medical Group. Dr. Bronsther is a graduate of the University of Rochester (B.A. 1973) and
Downstate Medical Center, Brooklyn, N.Y. (M.D. 1978). He did post-graduate work at Downstate Medical Center (Research Assistant 1975; Kidney Transplant
Fellowship 1983-1984), Mount Sinai Medical Center, New York, N.Y (Residency 1978-1983) and Childrens Hospital Medical Center, Boston, MA (Research
Fellowship 1980-1981). He resides in Potomac, MD.
Lowell Rush
, 57, was appointed a Director in April 2013 and is
Chairman of the Audit Committee. Mr. Rush has extensive experience in financial management and operational development, and since December 2013 has been Chief
Financial Officer of Ft. Lauderdale-based Direct Insite Corp (OTCQB:DIRI)., a leading provider of cloud-based e-invoicing solutions. Previously, he was Chief
Operating Officer of Miami-based Cosmetic Dermatology, Inc., and held positions as: CFO of Bijoux Terner, LLC (2008-2010); CFO of Little Switzerland, Inc.
(2006-2008); and VP Sales Operations of Rewards Network, Inc. He is a CPA with an MBA in International Business, who has also held financial management roles at
multi-national companies Sunglass Hut International, Burger King Corporation and Knight-Ridder, Inc. He began his career with the accounting
firms Ernst & Young and Deloitte & Touche.
Pascale Mangiardi
, 41, has been our director since October 2007.
She is presently the founder and President of Rougemont Management Services LLC. From 2002-2006, she was a financial officer for John R. Mangiardi, MD, PC and
from 2001 - 2002, she was the Assistant CEO at Hirslanden-Group Management AG, Zurich. Ms. Mangiardi holds a Diploma from the Swiss Business
Administration School.
All of our directors hold office until the next annual meeting of stockholders
and until their respective successors have been elected or qualified. Officers serve at the discretion of the board of directors. There are no family
relationships among our directors or executive officers. There is no arrangement or understanding between or among our officers and directors pursuant to which
any director or officer was or is to be selected as a director or officer, and there is no arrangement, plan or understanding as to whether non-management
stockholders will exercise their voting rights to continue to elect the current board of directors.
None of our directors and executive officers have during the past five years:
|
|
|
had any bankruptcy petition filed by or against any business of
which he was a general partner or executive officer, either at the time of the bankruptcy or within two years prior to that time;
|
|
been convicted in a criminal proceeding and is not subject to a
pending criminal proceeding;
|
|
been subject to any order, judgment or decree, not subsequently
reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his
involvement in any type of business, securities, futures, commodities or banking activities;
|
|
or been found by a court of competent jurisdiction (in a civil
action), the Securities Exchange Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and
the judgment has not been reversed, suspended or vacated.
|
45
Committees of the Board of Directors
Our Company has three committees of its Board of Directors(a) a
Nominating and Governance Committee (b) a Management Compensation Committee and (c) an Audit Committee. The Board of Directors has approved charters for
each committee. Steven Girgenti is Chairman of the Nominating and Governance Committee and the Management Compensation Committee, and Lowell Rush is a member.
Lowell Rush is Chairman of the Audit Committee and Steven Girgenti and Adrian Liddell are members. The Committees are intended to operate consistent with
applicable NASDAQ governance requirements.
Compensation Committee Interlocks and Insider Participation
None of our executive officers serves as a member of the Board of Directors or
compensation committee of any other entity that has one or more of its executive officers serving as a member of our Board of Directors.
There are no family relationships between our officers and
directors. Each director is elected at our annual meeting of stockholders and holds office until the next annual meeting of stockholders, or until
his successor is elected and qualified.
At the date of this prospectus, the Company is not engaged in any
transactions, either directly or indirectly, with any persons or organizations considered promoters.
Identification of Significant Employees
The Company does not presently have any significant employees other than the named
officers and directors.
Corporate Code of Conduct and Ethics
On September 25, 2007, the Company adopted a Code of Conduct and Ethics
applicable to the Board of Directors, management and all employees of the Company.
Officers and Directors Indemnification
Under our Certificate of Incorporation and Bylaws of the corporation, the
Company may indemnify an officer or director who is made a party to any proceeding, including a lawsuit, because of his or her position, if he or she acted in
good faith and in a manner he or she reasonably believed to be in the Companys best interest. The Company may advance expenses incurred in defending a
proceeding. To the extent that the officer or director is successful on the merits in a proceeding as to which he or she is to be indemnified, the Company must
indemnify the officer or director against all expenses incurred, including attorneys fees. With respect to a derivative action, indemnity may be made only
for expenses actually and reasonably incurred in defending the proceeding, and if the officer or director is judged liable, then only by a court order. The
indemnification coverage is intended to be to the fullest extent permitted by applicable laws.
Regarding indemnification for liabilities arising under the Securities Act
of 1933, which may be permitted to officers or directors under applicable state law, the Company is informed that, in the opinion of the Securities and Exchange
Commission, indemnification is against public policy, as expressed in the Act and is, therefore, unenforceable.
46
EXECUTIVE COMPENSATION
The following is a summary of the compensation we paid for each of the last two
years ended December 31, 2013 and 2012, respectively (i) to the persons who acted as our principal executive officer during our fiscal year ended December 31,
2013 and (ii) to the person who acted as our next most highly compensated executive officer other than our principal executive officer who was serving as an
executive officer as of the end of our last fiscal year.
|
|
|
|
|
|
|
|
|
|
Name and
Principal
Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Non-Equity
Incentive Plan
Compensation
|
Non-Qualified Deferred
Compensation Earnings
($)
|
All other
Compensation
($)
|
Total
($)
|
Kenneth T. Coviello
|
2013
|
$
|
|
|
|
|
|
|
|
(Chief Executive Officer*)
|
2012
|
$115,817
|
$70,643
|
|
|
|
|
|
$186,460
|
Richard P. Denness
|
2013
|
$
|
|
|
|
|
|
|
|
(Chief Executive Officer**)
|
2012
|
$57,500
|
|
|
|
|
|
|
$57,500
|
David Cantor
|
2013
|
$
|
|
|
|
|
|
|
|
(President)
|
2012
|
$
|
|
|
|
|
|
|
|
*Resigned effective August 3, 2012
**Resigned effective December 31, 2012
OUTSTANDING EQUITY AWARDS
Grants of Plan-Based Awards
Initial grants under the 2008 Stock Plan were to Kenneth T. Coviello and Heather N. Vinas of options to
purchase 1,000,000 shares in the aggregate. There were no option exercises by or stock vested any holder in fiscal 2013 or 2012. Following the resignation of
Heather N. Vinas, 1,111 options were cancelled.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option Awards
|
Name
|
Grant Date
|
Number of Securities Underlying Unexercised Options (#)
Exercisable
|
Equity Incentive Plan Awards: Number of Securities Underlying
Unexercised Unearned Options (#)
|
Number of Securities Underlying Unexercised Options (#)
Unexercisable (1)
|
|
Option
Exercise Price
($)
|
Option
Expiration Date
|
Kenneth T. Coviello
|
2/15/2008
|
|
-
|
3,334
|
|
$20.25
|
2/12/2018
|
|
|
|
|
|
|
|
|
Heather N. Vinas
|
2/15/2008
|
|
-
|
2,223
|
|
$20.25
|
2/12/2018
|
47
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Compensation Plan Information
|
Plan category
|
|
Number of securities to be issued upon exercise of
outstanding options, warrants and rights
(a)
|
|
Weighted-average exercise price of outstanding options,
warrants and rights
|
|
Number of securities remaining available
for future issuance under equity compensation plans (excluding securities
reflected in column (a)
|
Equity compensation plans approved
by security holders
|
|
6,667
|
|
$20.25
|
|
17,676
|
Equity compensation plans not approved by security holders
|
|
3,333
|
|
28.50
|
|
–
|
Total
|
|
7,000
|
|
$20.70
|
|
17,676
|
(1) As of December 31, 2013
Warrants Issued to Management
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Grant Date
|
|
Number of Securities Underlying Unexercised Exercisable
Warrants
|
|
Number of Securities Underlying Unexercised Exercisable
Warrants
|
|
Warrant Exercise Price
($)
|
|
Warrant Expiration Date
|
None
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
Employment Agreements
Effective as of January 2, 2014 (the “Effective Date”), the Company entered into separate, but
largely identical Employment Agreements with Messrs. Zachariou, Adrian Liddell and David Cantor. Mr. Zacharious Employment Agreement commences on the
Effective Date and terminates six months following the appointment of a successor Chief Executive Officer; Mr. Liddells Employment Agreement commences on
the Effective Date and terminates upon the appointment of a successor Chief Financial Officer; and Mr. Cantors Employment Agreement commences on the
Effective Date and terminates upon the appointment of a successor President of the Company. Each of the aforementioned Employment Agreements provides for annual
compensation of $110,000, payment of which is deferred for 12 months from the Effective Date and is subject to the achievement of certain enumerated milestone
conditions. Each of these Employment Agreements supersedes any prior employment agreements or arrangements between the respective parties.
Compensation of Directors
Each of our independent directors is entitled to receive $5,000 in cash or
stock at the option of the company per quarter. No other directors of the Company receive compensation for their service to the Company other than described
under
Employment Agreements
above.
48
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
OWNERS AND MANAGEMENT
The following table sets forth certain information with respect to the
beneficial ownership of our voting securities by (i) any person or group owning more than 5% of any class of voting securities, (ii) each director, (iii) our
chief executive officer and president and (iv) all executive officers and directors as a group as of May 23, 2014. Unless noted, the address for the
following beneficial owners and management is 6401 Congress Ave., Suite 140, Boca Raton, FL 33487.
|
|
|
|
|
|
|
Title of Class
|
|
Name and Address of Beneficial Owner
|
|
Amount and Nature of
Beneficial Owner (1)
|
|
Percent of
Class (2)
|
Common Stock
|
|
Steven Girgenti
|
|
33,613
|
|
*
|
Common Stock
|
|
Oscar Bronsther, M.D
|
|
20,960
|
|
*
|
Common Stock
|
|
Lowell Rush
|
|
6,834
|
|
*
|
Common Stock
|
|
Pascale Mangiardi
|
|
|
|
0.00%
|
Common Stock
|
|
Adrian Liddell
|
|
|
|
0.00%
|
Common Stock
|
|
David Cantor
|
|
|
|
0.00%
|
Common Stock
|
|
Peter Zachariou
|
|
|
|
0.00%
|
Common Stock
|
|
All executive officers and directors as a group
|
|
61,407
|
|
*
|
Common Stock
|
|
Fountainhead Capital Management Limited (3)
|
|
4,345,752
|
|
40.60%
|
* Less than 1%
|
|
(1)
|
In determining beneficial ownership of our common stock, the number
of shares shown includes shares which the beneficial owner may acquire upon exercise of debentures, warrants and options which may be acquired within 60 days.
In determining the percent of common stock owned by a person or entity on May 23, 2014, (a) the numerator is the number of shares of the class beneficially
owned by such person or entity, including shares which the beneficial ownership may acquire within 60 days of exercise of debentures, warrants and options, and
(b) the denominator is the sum of (i) the total shares of that class outstanding on May 23, 2014 (10,703,494 shares of common stock) and (ii) the total number
of shares that the beneficial owner may acquire upon exercise of the debentures, warrants and options. Unless otherwise stated, each beneficial owner has sole
power to vote and dispose of its shares.
|
(2)
|
In addition, in determining the percent of common stock owned by a
person or entity on May 23, 2014, (a) the numerator is the number of shares of the class beneficially owned by such person and includes shares which the
beneficial owner may acquire within 60 days upon conversion or exercise of a derivative security, and (b) the denominator is the sum of (i) the shares of that
class outstanding on May 23, 2014 (10,703,494 shares of common stock) and (ii) the total number of shares that the beneficial owner may acquire upon conversion
or exercise of a derivative security within such 60 day period. Unless otherwise stated, each beneficial owner has sole power to vote and dispose of the shares.
|
(3)
|
The address of Fountainhead Capital Management Limited is Portman
House, Hue Street, St. Helier, Jersey JB4 5RP. Carole Dodge, for and on behalf of Berwin Limited, and Eileen OShea, for and on behalf of Moulton
Limited, in their capacity as corporate directors of Fountainhead Capital Management Limited, hold voting and dispositive power over shares of the
Companys Common Stock held by Fountainhead Capital Management Limited.
|
49
TRANSACTIONS WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS AND DIRECTOR INDEPENDENCE
Related Party Transactions
During July 2012, the Company issued unsecured, subordinated loan notes to Fountainhead for a total of
$100,000. The loan notes are subordinated to the Companys secured debentures, bear interest at a rate of 6% are due on demand or by July 9, 2013.
During January to December 2013, the Company issued unsecured, subordinated loan notes to:
Fountainhead for a total of $415,744; to Peter Zachariou, a director of the Company, for a total of $210,000; and to David Cantor, a director of the Company,
for a total of $15,000. The loan notes are subordinated to the Companys secured debentures and Preferred C Stock of the Company, bear interest at a rate
of 6% are due on demand or by their one-year anniversary.
During April to September 2013, Fountainhead Capital Management sold 177,439 warrants to purchase
Vycor Common Stock at an exercise price of $1.88 per share. These warrants were granted to Fountainhead by the Company in February 2010 and were sold by
Fountainhead to 7 investors at a price of $0.10 per warrant. The warrants were immediately exercised by the investors.
Under the terms of the Private Placement, there were certain agreements with Related Parties:
(a)
Debt Amendment and Repayment
. Fountainhead and Peter
Zachariou agreed to extend the maturity of all of the Companys debt obligations due to them due to as of August 9, 2013 (aggregating $2,247,037) to
January 2, 2017, subject to the earlier repayment of such debt upon the occurrence of certain specified conditions. Fountainhead and Peter Zachariou
further released all security interests associated with any of the obligations and agreed to forebear declaring any event of default under the obligations for a
period of 24 months following the date of the Initial Closing. During January and February 2014, also under the terms of the Offering, debt obligations arising
since August 9, 2013 were repaid as follows: Fountainhead - $91,519; Peter Zachariou - $20,000; David Cantor - $15,000.
(b)
Employment of Chief Executive Officer and Employment Agreements.
Effective as of January 2,
2014, our board of directors appointed Peter C. Zachariou, our Executive Vice President, to the additional role as the Companys Chief Executive Officer.
Also effective as of the January 2, 2014 the Company entered into separate, but largely identical Employment Agreements with Mr. Zachariou, Adrian Liddell and
David Cantor. Mr. Zacharious Employment Agreement commences on the Effective Date and terminates six months following the appointment of a successor Chief
Executive Officer; Mr. Liddells Employment Agreement commences on the Effective Date and terminates upon the appointment of a successor Chief Financial
Officer; and Mr. Cantors Employment Agreement commences on the Effective Date and terminates upon the appointment of a successor. The aforementioned
Employment Agreements provide for annual compensation of $110,000, payment of which is deferred for 12 months from the Effective Date and is subject to the
achievement of certain enumerated milestone conditions. Each of these Employment Agreements supersedes any prior employment agreements or arrangements between
the respective parties.
(c)
Amendment to Consulting Agreement.
Effective as of January 2, 2014, the Company and
Fountainhead amended their Consulting Agreement to extend the term of the Consulting Agreement to the date which is one (1) year following the date of the
Initial Closing. As of the date of the Amendment, the monthly retainer payable to Fountainhead was reduced to $10,000 per month, payable $5,000 in cash
and the remainder accrued or payable in Company Common Stock until the occurrence of specified milestones.
(d)
Conversion Agreement.
Effective as of January 2, 2014, the Company and Fountainhead entered
into a Conversion Agreement whereby Fountainhead agreed to convert all amounts accrued as of the date of the Initial Closing into an investment in that amount
in the Offering. Pursuant to the terms of this agreement, Fountainhead converted $1,426,542 of accrued consulting fees into the Units. Effective May 15,
2014 Fountainhead entered into an Amendment and Waiver Agreement to waive their anti-dilution rights on the Series A Warrants received in respect of this
conversion (which arose in the event the Company sold securities at a price below $2.05 within one year of the date that the initial Registration Statement has
been declared effective by the SEC) in consideration of the Companys agreement not to sell any securities at a price below $2.05 within such one-year
period.
50
On March 31 2014, in accordance with the terms the Consulting Agreement, the Company issued
6,276 shares of Common Stock (valued at $15,000) to Fountainhead.
Other
The officers and directors for the Company are involved in other business activities and may,
in the future, become involved in other business opportunities. If a specific business opportunity becomes available, such persons may face a conflict in
selecting between the Company and their other business interest. The Company has not formulated a policy for the resolution of such conflicts.
Director Independence
The Company has four independent directors within the meaning of Nasdaq
Marketplace Rule 4200Steven Girgenti, Lowell Rush, Pascale Mangiardi and Oscar Bronsther, M.D.
EXPERTS
Our financial statements for the fiscal years ended December 31, 2013 and December 31, 2012
along with the related consolidated statements of operations, stockholders equity and cash flows in this prospectus have been audited by Paritz & Co
P.C., of Hackensack, New Jersey, independent registered public accounting firm, to the extent and for the periods set forth in their report, and are set forth
in this prospectus in reliance upon such report given upon the authority of them as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
Our filings are available to the public at the SECs web site at
www.sec.gov. You may also read and copy any document with the SEC at the SECs Public Reference Room at 100 F Street, NE, Washington, D.C.
20549. Further information on the Public Reference Room may be obtained by calling the SEC at 1-800-SEC-0330.
We have filed a registration statement on Form S-1 with the SEC under the Securities Act for
the common stock offered by this prospectus. This prospectus does not contain all of the information set forth in the registration statement, certain
parts of which have been omitted in accordance with the rules and regulations of the SEC. For further information, reference is made to the
registration statement and its exhibits. Whenever we make references in this prospectus to any of our contracts, agreements or other documents, the
references are not necessarily complete and you should refer to the exhibits attached to the registration statement for the copies of the actual contract,
agreement or other document.
INCORPORATION OF CERTAIN MATERIAL BY REFERENCE
The Company does not elect to incorporate any material by reference.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
The Securities and Exchange Commissions Policy on Indemnification
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers, and controlling persons of the company pursuant to any provisions contained in its Articles of Incorporation, Bylaws, or
otherwise, the registrant has been advised that, in the opinion of the Securities and Exchange Commission,
51
such indemnification is against public policy as expressed in the Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or
paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director,
officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of registrants legal counsel
the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether indemnification is against public
policy as expressed in the Act and will be governed by the final adjudication of such issue.
FINANCIAL STATEMENTS
Our consolidated financial statements are included with this
prospectus. These financial statements have been prepared on the basis of accounting principles generally accepted in the United States and are
expressed in US dollars.
Index to Financial Statements
|
|
|
Fiscal years ended December 31, 2013 and December 31, 2012 (audited)
|
|
Three months ended March 31, 2014 and March 31, 2013 (unaudited).
|
|
52
REPORT OF INDEPENDENT REGISTERED ACCOUNTING FIRM
Board of Directors
Vycor Medical Inc. and
Subsidiaries
Boca Raton, Florida
We have audited the accompanying consolidated balance
sheets of Vycor Medical Inc. and Subsidiaries as of December 31, 2013 and 2012 and the related consolidated statements of comprehensive loss, changes in
stockholders equity (deficit) and cash flows for the years then ended. These financial statements are the responsibility
of the Companys management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of
the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable
assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform
an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Companys internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements
referred to above present fairly, in all material respects, the financial position of Vycor Medical Inc. and Subsidiaries as of December 31, 2013 and
2012 and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the
United States of America.
Hackensack, New Jersey
April 7, 2014
F-1
VYCOR MEDICAL, INC.
Consolidated Balance Sheets
|
|
|
|
December 31,
2013
|
|
December 31,
2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
31,303
|
|
|
$
|
59,821
|
|
Trade accounts receivable, net of allowance for doubtful accounts of $6,474 and $2,754
|
|
|
|
|
212,660
|
|
|
|
144,347
|
|
|
|
|
|
|
206,926
|
|
|
|
290,508
|
|
Prepaid expenses and other current assets
|
|
|
|
|
208,063
|
|
|
|
429,102
|
|
|
|
|
|
|
658,952
|
|
|
|
923,778
|
|
|
|
|
|
|
|
706,197
|
|
|
|
827,389
|
|
|
Intangible and Other assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
251,157
|
|
|
|
251,157
|
|
Patents, net of accumulated amortization
|
|
|
|
|
444,095
|
|
|
|
502,895
|
|
Website, net of accumulated amortization
|
|
|
|
|
1,680
|
|
|
|
2,772
|
|
|
|
|
|
|
53,169
|
|
|
|
53,169
|
|
Total Intangible and Other assets
|
|
|
|
|
750,101
|
|
|
|
809,993
|
|
|
|
|
|
|
$
|
2,115,250
|
|
|
$
|
2,561,160
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIENCY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
254,024
|
|
|
$
|
187,789
|
|
Accrued interest: Related Party
|
|
|
|
|
238,299
|
|
|
|
107,176
|
|
|
|
|
|
|
147,984
|
|
|
|
87,962
|
|
|
|
|
|
|
1,776,867
|
|
|
|
1,198,463
|
|
Other current liabilities
|
|
|
|
|
61,576
|
|
|
|
241,918
|
|
Notes payable: Related Party
|
|
|
|
|
2,373,556
|
|
|
|
1,732,812
|
|
|
|
|
|
|
578,186
|
|
|
|
462,690
|
|
|
TOTAL CURRENT AND TOTAL LIABILITIES
|
|
|
|
|
5,430,492
|
|
|
|
4,018,810
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 16.2 and 39.3 issued and outstanding as at December 31, 2013 and 2012
respectively
|
|
|
|
$
|
1
|
|
|
$
|
1
|
|
Common Stock, $0.0001 par value, 25,000,000 shares authorized at December 31, 2013 and 2012, 6,757,225 and
6,020,555 shares issued and outstanding at December 31, 2013 and 2012 respectively
|
|
|
|
|
675
|
|
|
|
602
|
|
Additional Paid-in Capital
|
|
|
|
|
13,762,689
|
|
|
|
13,141,489
|
|
Treasury Stock (103,334 and 68,889 shares of Common Stock as at December 31, 2013 and 2012 respectively, at cost)
|
|
|
|
|
(1,033
|
)
|
|
|
(1,033
|
)
|
|
|
|
|
|
(17,032,405
|
)
|
|
|
(14,587,914
|
)
|
Accumulated Other Comprehensive Income
|
|
|
|
|
(45,170
|
)
|
|
|
(10,795
|
)
|
Total Stockholders Deficiency
|
|
|
|
|
(3,315,243
|
)
|
|
|
(1,457,650
|
)
|
|
TOTAL LIABILITIES AND STOCKHOLDERS DEFICIENCY
|
|
|
|
$
|
2,115,250
|
|
|
$
|
2,561,160
|
|
See accompanying notes to financial
statements.
F-2
VYCOR MEDICAL, INC.
Consolidated Statement of
Comprehensive Loss
|
|
|
|
For the year ended
December 31,
|
|
|
|
|
|
2013
|
|
2012
|
|
|
|
|
$
|
1,089,374
|
|
|
$
|
1,205,263
|
|
|
|
|
|
|
153,832
|
|
|
|
179,530
|
|
|
|
|
|
|
935,542
|
|
|
|
1,025,733
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53,451
|
|
|
|
126,042
|
|
Depreciation and Amortization
|
|
|
|
|
350,526
|
|
|
|
328,890
|
|
General and administrative
|
|
|
|
|
2,813,041
|
|
|
|
3,413,004
|
|
Negative Goodwill on Acquisition of Subsidiary
|
|
|
|
|
|
|
|
|
(66,394
|
)
|
Costs related to Acquisition of Subsidiary
|
|
|
|
|
|
|
|
|
18,285
|
|
|
|
|
|
|
3,217,018
|
|
|
|
3,819,827
|
|
|
|
|
|
|
|
(2,281,476
|
)
|
|
|
(2,794,094
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
719
|
|
Interest expense: Related Party
|
|
|
|
|
(131,400
|
)
|
|
|
(87,268
|
)
|
|
|
|
|
|
(59,897
|
)
|
|
|
(50,663
|
)
|
Total Other Income (expense)
|
|
|
|
|
(191,297
|
)
|
|
|
(137,212
|
)
|
|
|
|
|
|
$
|
(2,472,773
|
)
|
|
$
|
(2,931,306
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment
|
|
|
|
|
28,282
|
|
|
|
5,096
|
|
|
|
|
|
$
|
(2,444,491
|
)
|
|
$
|
(2,926,210
|
)
|
|
Comprehensive Loss Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(0.39
|
)
|
|
$
|
(0.52
|
)
|
|
Weighted Average Number of Shares Outstanding
|
|
|
|
|
6,324,175
|
|
|
|
5,637,690
|
|