Note
2 – Management’s Liquidity Plan
As
of September 30, 2022, the Company had a cash balance of $2.9 million, investments of $39.8 million and working capital of $39.4 million.
Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain
its operations, pursue its product development initiatives and penetrate markets for the sale of its products, Management believes that
our capital resources at September 30, 2022 are sufficient to meet our obligations as they become due within one year after the date
of this Quarterly Report, and sustain operations.
ENVVENO
MEDICAL CORPORATION
NOTES
TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note
3 – Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted
in the United States of America (“GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly,
they do not include all of the information and disclosures required by accounting principles generally accepted in the United States
of America for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only
of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of
the Company as of September 30, 2022 and December 31, 2021, and for the three and nine months ended September 30, 2022 and 2021. The
results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the operating results
for the full year. These unaudited condensed financial statements should be read in conjunction with the financial statements and notes
thereto for the year ended December 31, 2021 included in the Company’s Form 10-K filed with the SEC on March 28, 2022. The condensed
balance sheet as of December 31, 2021 has been derived from the Company’s audited financial statements.
Investments
We
consider all highly liquid interest-earning investments with a maturity of three months or less at the date of purchase to be cash equivalents.
The fair values of these investments approximate their carrying values. Investments with original maturities of greater than three months
and remaining maturities of less than one year are classified as short-term investments. Investments with maturities beyond one year
are classified as long-term investments.
Debt
investments are classified as trading securities and realized gains and losses are recorded using the specific identification method.
Changes in fair value, excluding credit losses and impairments, are recorded in unrealized gains (losses) from investments. Fair value
is calculated based on publicly available market information. If the cost of an investment exceeds its fair value, we evaluate, among
other factors, general market conditions, credit quality of debt instrument issuers, and the extent to which the fair value is less than
cost. We recognize interest income based on the stated coupon rate of the investments purchased.
Note
4 – Investments
The
components of investments were as follows at September 30, 2022:
Schedule of Investments
(In
thousands)
| | |
Cash
Equivalents | | |
Short-Term
Investment | | |
Long
Term Investment | |
| Fair Value Level 1 | |
| | | |
| | | |
| | |
| U.S. Government
securities | |
$ | 2,126 | | |
$ | 37,432 | | |
$ | 2,398 | |
| Total debt investments | |
$ | 2,126 | | |
$ | 37,432 | | |
$ | 2,398 | |
Unrealized
losses from fixed-income securities are primarily attributable to changes in interest rates. Management does not believe any remaining
unrealized losses represent impairments based on our evaluation of available evidence. There were no similar investments at December
31, 2021.
ENVVENO
MEDICAL CORPORATION
NOTES
TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note
5 – Concentrations
The
Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal
Deposit Insurance Corporation (“FDIC”) up to $250 at each institution. There were aggregate uninsured cash balances of $2.6
million and $54.5 million as of September 30, 2022 and December 31, 2021, respectively.
Note
6 – Accrued Expenses and Other Current Liabilities
As
of September 30, 2022, and December 31, 2021, accrued expenses and other current liabilities consist of the following:
Schedule of Accrued
Expenses and Other Current Liabilities
| | |
September
30, | | |
December 31, | |
| (In thousands) | |
2022 | | |
2021 | |
| Accrued compensation costs | |
$ | 394 | | |
$ | 525 | |
| Accrued professional fees | |
| 40 | | |
| 84 | |
| Accrued research and development | |
| - | | |
| 60 | |
| Other accrued expenses | |
| 61 | | |
| 60 | |
| Accrued
expenses | |
$ | 495 | | |
$ | 729 | |
Note
7 – Commitments and Contingencies
Litigations
Claims and Assessments
In
the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course
of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable
settlements.
Robert
Rankin Complaints
On
July 9, 2020, the Company was served with a civil complaint filed in the Superior Court for the State of California, County of Orange
by a former employee, Robert Rankin, who resigned his employment on or about March 30, 2020. The case is entitled Rankin v. Hancock Jaffe
Laboratories, Inc. et al., Case No. 30-2020-01146555-CU-WR-CJC and was filed on May 27, 2020. On September 3, 2020 the Company and its
Chief Executive Officer were served with a second complaint filed in the Superior Court for the State of California, County of Orange
by Mr. Rankin. The case is entitled Rankin v. Hancock Jaffe Laboratories, Inc. et al., Case No. 30-2020-01157857 and was filed on August
31, 2020. The complaints assert several causes of action including a cause of action for failure to timely pay Mr. Rankin’s accrued
and unused vacation and three months’ severance under his July 16, 2018 employment agreement, defamation, unlawful labor code violations,
sex-based discrimination, and unfair competition, and seeks damages for lost wages, emotional and mental distress, consequential damages,
punitive damages and attorney’s fees and costs. The Company has denied all claims in both matters (which have now been consolidated)
and has filed a counterclaim asserting that Rankin has breached his employment agreement with the Company to the Company’s damage.
The Company continues to believe it has meritorious defenses to both matters which are currently set for trial on June 12, 2023.
As of
the date of these financial statements, the amount of loss associated with these complaints, if any, cannot be reasonably estimated.
ENVVENO
MEDICAL CORPORATION
NOTES
TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note
8 –Stockholders’ Equity
Stock
Options
From
time to time, the Company issues options for the purchase of its common stock to employees and others. During the nine-months ended September
30, 2022, the Company granted options to employees for the purchase off forty-three thousand shares with a weighted average exercise
price of $6.76 per share.
The Company recognized $6.6 million and $0.7 million of share-based compensation related to stock options during
the nine months ended September 30, 2022 and 2021, respectively.
As of September 30, 2022, there was $8.6 million of unrecognized stock-based
compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period
of 1.6 years.
Note
9 – Net Loss per Share
The
following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss
per common share as of September 30, 2022 and 2021:
Schedule
of Dilutive Net Loss Per Common Share
| | |
2022 | | |
2021 | |
| | |
September
30, | |
| (In thousands) | |
2022 | | |
2021 | |
| Shares of common stock issuable upon exercise of
warrants | |
| 4,570 | | |
| 4,554 | |
| Shares of common stock issuable upon exercise
of options | |
| 3,438 | | |
| 485 | |
| Potentially dilutive
common stock equivalents excluded from diluted net loss per share | |
| 8,008 | | |
| 5,039 | |
Item
2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion should be read in conjunction with our unaudited condensed financial statements and notes thereto included herein.
In connection with, and because we desire to take advantage of, the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995, we caution readers regarding certain forward-looking statements in the following discussion and elsewhere in this
report and in any other statement made by, or on our behalf, whether or not in future filings with the Securities and Exchange Commission.
Forward-looking statements are statements not based on historical information and which relate to future operations, strategies, financial
results or other developments. Such forward-looking statements involve significant risks and uncertainties. Forward looking statements
are necessarily based upon estimates and assumptions that are inherently subject to significant business, economic and competitive uncertainties
and contingencies, many of which are beyond our control and many of which, with respect to future business decisions, are subject to
change. These uncertainties and contingencies can affect actual results and could cause actual results to differ materially from those
expressed in any forward-looking statements made by, or on our behalf. Words such as “anticipate,” “estimate,”
“plan,” “continuing,” “ongoing,” “expect,” “believe,” “intend,”
“may,” “will,” “should,” “could,” and similar expressions are used to identify forward-looking
statements. Such forward-looking statements also involve other factors which may cause our actual results, performance or achievements
to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and
to vary significantly from reporting period to reporting period. Although management believes that the assumptions made and expectations
reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove
to be correct or that actual future results will not be different from the expectations expressed in this Quarterly Report. We undertake
no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise,
except as required by applicable law.
Unless
the context requires otherwise, references in this document to “NVNO”, “we”, “our”, “us”
or the “Company” are to EnVVeno Medical Corporation
Overview
enVVeno
Medical Corporation is a late clinical-stage med-tech company focused on the advancement of innovative bioprosthetic (tissue-based) solutions
to improve the standard of care for the treatment of venous disease. The Company’s lead product, the VenoValve®, is a first-in-class
surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is
also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe™.
CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling
in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult
to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up
the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal study and the company is
currently waiting for regulatory approval to begin the TAVVE first-in-human trial for enVVe. Our team of officers and directors has been
affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful.
We develop and manufacture our products in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO
13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.
VenoValve
The
VenoValve is a porcine based replacement venous valve developed at enVVeno Medical to be implanted in the deep venous system of the
leg to treat severe CVI. By reducing reflux and lowering pressure (venous hypertension) within the deep venous system of the leg,
the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal
recurring venous leg ulcers. The VenoValve is implanted into the femoral vein of the patient
in an open surgical procedure via a 5-to-6-inch incision in the upper thigh.
There
are presently no FDA approved medical devices to address valvular incompetence in the deep venous system, or effective treatments for
deep venous CVI. Current treatment options include compression garments, or constant leg elevation, and wound care for venous ulcers.
These treatments are generally ineffective, as they attempt to alleviate the symptoms of CVI without addressing the underlying causes
of the disease. In addition, we believe compliance with compression garments and leg elevation is extremely low, especially among the
elderly. The premise behind the VenoValve is that by reducing the underlying causes of CVI, reflux and venous hypertension, the debilitating
symptoms of CVI will decrease, resulting in improvement in the quality of the lives of CVI sufferers.
We
estimate that there are approximately 2.4 million people in the U.S. who would be candidates for the VenoValve.
VenoValve
Clinical Status
After
consultation with the FDA, and as a precursor to the U.S. pivotal trial, we conducted a small first-in-human study for the VenoValve
in Colombia which included eleven (11) patients. Endpoints for the VenoValve first-in-human
study included safety (device related adverse events), reflux, measured by doppler, an rVCCS score, which is used by the clinician to measure disease
regression and progression, a VAS score used by the patient to measure pain, and a quality of life measurement.
Final
results from the one (1) year first-in-human study were presented at the Charing Cross International Symposium in April of 2021. Among
the eleven (11) patients in the study, reflux improved an average of 54%, Venous Clinical Severity Scores (“VCSSs”) improved
an average of 56%, and visual analog scale (VAS) scores, which are used by patients to measure pain, improved an average of 76%, all
at one (1) year when compared to pre-surgery levels. VCSS scores are commonly used by clinicians in practice and in clinical trials to
objectively assess outcomes in the treatment of venous disease, and include ten characteristics including pain, inflammation, skin changes
such as pigmentation and induration, the number of active ulcers, and ulcer duration. The improvement in VCSS scores is significant and
indicates the VenoValve patients who had severe CVI pre-surgery, had mild CVI or the complete absence of disease at one-year post surgery.
There
were no device related safety incidences during the one (1) year first-in-human study. Non-device related safety incidences were minor
and included one (1) fluid pocket (which was aspirated), intolerance from Coumadin anticoagulation therapy, three (3) minor wound infections
(treated with antibiotics), and one occlusion due to patient non-compliance with anti-coagulation therapy.
An
IDE from the FDA is required before a medical device company can proceed with a pivotal trial for a class III medical device. On April
1, 2021, we received notification from the FDA that our IDE application for the VenoValve U.S. pivotal trial was approved. We have named
the U.S. pivotal trial for the VenoValve the SAVVE (Surgical Anti-reflux Venous Valve
Endoprosthesis) study. It is a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients
to be enrolled at up to twenty (20) U.S. sites.
No
product modifications for the VenoValve were necessary following the first-in-human study and the SAVVE trial is evaluating the same
device that was used in the first-in-human study. Endpoints for the SAVVE trial mirror those endpoints used for the first-in-human
study. The primary safety endpoint for the pivotal trial is a material adverse safety event (mortality, deep wound infection, major
bleeding, ipsilateral deep vein thrombosis, pulmonary embolism) in no more than twenty six percent (26%) of the patients at one (1)
month post implantation, and the primary effectiveness endpoint for the pivotal trial is improvement in reflux of at least thirty
percent (30%), measured at six (6) months post VenoValve implantation in at least fifty five percent (55%) of the patients. In the first-in-human study there were no reported material
adverse safety events at one (1) month post implantation, and reflux improved an average of fifty six percent (56%) at six (6)
months post implantation. At least a thirty percent (30%) improvement in reflux occurred in ninety
percent (90%) of the patients. rVCSS scoring to measure disease manifestations, VAS scores to measure pain, and quality of life
measurements will also be monitored in the study.
On
August 3, 2020, we announced that the FDA granted Breakthrough Device Designation status to the VenoValve. The FDA’s Breakthrough
Devices Program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening
or irreversibly debilitating diseases or conditions. The goal of the FDA’s Breakthrough Devices Program is to provide patients
and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving
the FDA’s mission to protect and promote public health.
At
the end of the VenoValve first-in-human study, eight (8) study participants agreed to additional monitoring. In August of 2021,
longer-term two (2) year follow-up data was presented at the Society of Vascular Surgery Conference in San Diego, for the cohort of
eight (8) patients. That data indicated no recurrences of the severe CVI that was present pre-VenoValve, including no ulcer
recurrences for those patients whose venous ulcers had healed following VenoValve surgery. There were no reported safety issues from
the end of one (1) year first-in-human study to the end of the two (2) year reporting period. In addition, the patients continued to
improve, reporting 63%, 60%, and 93%, average improvements in reflux, VCSS, and VAS scores, respectively, at an average of two (2)
years post VenoValve surgery compared to pre-VenoValve levels.
In
October of 2021, we announced that the first patient in the SAVVE pivotal trial underwent successful VenoValve implantation surgery and
had been discharged from the hospital. During April 2022 our twentieth site in the SAVVE study became active and is eligible to enroll
patients.
COVID
continues to have indirect consequences on the SAVVE clinical trial. As reported
in the media, the effects of COVID COVID have resulted in an exodus of health care providers leaving the profession. These staffing issues continue
to put an enormous strain on all hospital resources including clinical staffs. This lack of available clinical personnel continues to slow enrollment at our clinical
sites.
COVID
also impacts our patient population. Patients with COVID or who are unwilling to get vaccinated, are currently excluded
from our study. In addition, concerns about getting COVID impact the patients’
willingness to undergo an elective surgical procedure with a one-night hospital stay. Our goal continues to be to fully enroll the SAVVE pivotal trial by the end of the first quarter of 2023. We continue to monitor
patient enrollment and will change our enrollment guidance for SAVVE, if necessary, when we have sufficient information
to do so.
enVVe
On
September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe™,
for the treatment of CVI of the deep veins of the leg. Preliminary bench testing and animal testing for enVVe have already been
successfully completed and the Company has filed an application seeking approval to begin first-in-human (FIH) testing in Columbia, which we
expect to receive by the end of 2022.
The
enVVe first-in-human trial, which will take place in Colombia, will be known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis
(TAVVE) FIH study. The initial phase of the TAVVE-FIH study will seek to enroll 3 to 5 patients across multiple sites. Several parameters
will be evaluated over the course of the study including safety and technical success of the enVVe venous valve delivery system, and
the safety and clinical performance of the enVVe venous valve.
enVVe
is delivered into the femoral vein of the patient via a minimally invasive procedure requiring no general anesthesia and no overnight
hospital stay. Due to the minimally invasive nature of the procedure, we estimate the U.S. market for enVVe to be approximately 3.5 million
patients.
Capital
In
February of 2021, we raised $41.4 million of capital in a public offering of our common stock. In September of 2021, we raised $20
million dollars of capital in a registered direct offering priced at the market under Nasdaq rules and purchased by a fund managed
by Perceptive Advisors, a leading life sciences investment firm. We finished 2021 with approximately $55 million of cash and had
approximately $2.9 million of cash and $39.8 million of investments at September 30, 2022. At our existing cash burn rate of
approximately $4 million per quarter, we should have sufficient cash to fund operations through the end of 2024 and into 2025.
Comparison
of the three months ended September 30, 2022 and 2021
Overview
We
reported net losses of $6.1 million and $2.4 million for the three months ended September 30, 2022 and 2021, respectively, representing
an increase in net loss of $3.7 million or 154%, due to an increase in operating expenses of $3.4 million, and a net decrease in other
income and expense of $0.3 million.
Revenues
As
a developmental stage Company, we are not currently generating revenue and our future revenue, if any, is expected to be diminutive
and dependent on our ability to commercialize our product candidates.
Selling,
General and Administrative Expenses
For
the three months ended September 30, 2022, selling, general and administrative expenses increased by $2.1 million or 140%, to $3.6 million
from $1.5 million for the three months ended September 30, 2021. Of this increase, $1.9 million was due to share-based compensation from
grants made during 2021, which increased share-based compensation cost to $2.2 million in 2022 from $0.3 million in 2021. The remaining
$0.2 million increase reflects higher legal expenses related to building the Company’s patent portfolio.
Research
and Development Expenses
For
the three months ended September 30, 2022, research and development expenses increased by $1.3 million or 108%, to $2.5 million from
$1.2 million for the three months ended September 30, 2021. This increase primarily resulted from $0.8 million in costs related the SAVVE
study, $0.3 million in lab costs to support the SAVVE study and VenoValve continued development, and $0.2 million increase in personnel
costs due to additional staff.
Gain
on Extinguishment of Note Payable
For
the quarter ended September 30, 2021 the Company recorded a one-time $0.3 million gain on extinguishment of note payable due to the forgiveness
of the loan it had obtained under the PPP program authorized by the CARES act.
Comparison
of the nine months ended September 30, 2022 and 2021
Overview
We
reported net losses of $18.5 million and $7.5 million for the nine months ended September 30, 2022 and 2021, respectively,
representing an increase in net loss of $11.0 million, or 147%, due to an increase in operating expenses of $10.6 million, and a
decrease in other income and expense of $0.4 million.
Revenues
As
a developmental stage Company, we are not currently generating revenue and our future revenue, if any, is expected to be diminutive
and dependent on our ability to commercialize our product candidates.
Selling,
General and Administrative Expenses
For
the nine months ended September 30, 2022, selling, general and administrative expenses increased $7.3 million or 183%, to $11.3 million
from $4.0 million for the nine months ended September 30, 2021. Of this increase, $6.1 million was due to share-based compensation from
grants made during 2021, which increased share-based compensation cost to $6.7 million in 2022 from $0.6 million in 2021.
The
remaining $1.2 million increase in expenses is attributable to $0.4 million from higher legal costs mainly related to building the Company’s patent portfolio,
$0.3 million of consulting costs for reimbursement codes for the Company’s product to be used once the product is commercially
approved, if ever, $0.3 million from higher information technology and other office expense to support increases in staff, $0.1 million
from higher compensation cost, and $0.1 million from higher insurance costs related to increased coverages for cyber risks and higher
D&O insurance premiums.
Research
and Development Expenses
For
the nine months ended September 30, 2022, research and development expenses increased by $3.1 million or 78%, to $7.1 million from $4.0
million for the nine months ended September 30, 2021.
This
increase primarily resulted from $2.8 million in costs related the SAVVE study, $0.2 million in lab costs to support the SAVVE study
and VenoValve continued development, and $0.1 million in travel costs
to support the SAVVE study.
Gain
on Extinguishment of Note Payable
For
the nine months ended September 30, 2021 the Company recorded a $0.3 million gain on extinguishment of note payable due to the forgiveness
of the loan it had obtained under the PPP program authorized by the CARES act.
Liquidity
and Capital Resources
For
the nine-months ended September 30, 2022, the Company incurred losses from operations of $18.5 million and used $11.7 million cash in
operating activities. The net cash used in operating activities during the 2022 period increased by $3.0 from $8.7 million for the nine-months
ended September 30, 2021.
The
losses and the uses of cash are primarily due to the Company’s administrative and product research and development activities.
Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as
internal administrative functions. Research and development activities are for continued product development and clinical trials for
the VenoValve, currently primarily the SAVVE study. The Company will continue to incur these costs to complete its clinical trials, enhance
products, develop new products, and operate as a public company. Although we have discretion in how we use the Company’s cash resources,
we expect to continue these activities for the foreseeable future as we seek to obtain regulatory approval for our lead product candidate.
We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate.
Our
cash flows from investing activity have historically consisted of purchases of property and equipment for our lab and offices. However,
during the period ending September 30, 2022, we commenced a program to invest excess cash in US Treasury bills. In the nine months ended
September 30, 2022, we purchased $42.2 million of these investments and expect to continue investing as the treasury bills mature and
as allowed by the cash requirements of our operations. Also, during the nine months ending September 30, 2022, we purchased $0.1 million
of property and equipment consisting primarily of lab and test equipment.
We
do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment
of $0.4 million per year. However, we expect a modest increase in purchases of property and equipment as we continue SAVVE and plan for
commercialization of the VenoValve.
The
Company has historically funded its operations through financing activities such as the capital raises completed in 2021. During 2021,
the Company raised an aggregate of $57.4 million in net proceeds in private and public placements of its securities. Our cash balance
as of September 30, 2022, is $2.9 million. In addition, we have $39.8 million in investments, for total cash and investments of $42.7
million.
Our
future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials
and related product development costs and our ability to successfully bring products to market. At our existing cash burn rate of approximately
$4 million per quarter, we should have sufficient cash to fund operations through the end of 2024 and into 2025. With primary endpoints
following full enrollment in the SAVVE pivotal trial of thirty (30) days for safety, and six (6) months for effectiveness, we expect
to have primary endpoint data well in advance of the need to raise additional capital. Any inability to raise additional financing would
have a material adverse effect on us.
Based
upon our cash and working capital as of September 30, 2022, we have sufficient capital resources to meet our obligations as they become
due for at least one year after the date of this Report and sustain operations.
As
of October 25, 2022, our cash balance was $2.0 million and our investment balance was $39.9 million.
The
COVID-19 pandemic continues to disrupt the global economy and has negatively impacted large populations including people and businesses
that may be directly or indirectly involved with the operation of our Company and the manufacturing, development, and testing of our
product candidates. COVID with its variants continues to have both direct and indirect consequences on our clinical trial. Several of
our clinical sites put elective surgeries on hold and prohibited potential study subjects from coming to the hospital for screening.
Further COVID resurgences put an enormous strain on all hospital resources including clinical staffs. The lack of available clinical
personnel both slows enrollment and impacts the speed at which we can activate clinical sites.
COVID
has also impacted our patient population. Patients with COVID or who have had COVID within ninety (90) days of their screening, are excluded
from our study until after the ninety (90) day period has passed. In addition, concerns about getting COVID impact the patients’
willingness to undergo an elective surgical procedure with a one-night hospital stay. As hospital clinical operations return to more
normal levels, our goal is to fully enroll the SAVVE pivotal trial by the end of 2022 or the beginning of 2023. We continue to monitor
the ongoing overall impact of COVID on the SAVVE clinical trial and will issue updates when appropriate.
Off-Balance
Sheet Arrangements
None.
Contractual
Obligations
As
a smaller reporting company, we are not required to provide the information requested by paragraph (a)(5) of this Item.
Critical
Accounting Policies and Estimates
For
a description of our critical accounting policies, see Note 4 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly
Report on Form 10-Q.