Daxor Corporation (NYSE: DXR), the global leader in blood volume
measurement technology, announces today it issued a corporate
update in a Letter to Shareholders filed in its certified
shareholder report on form N-CSR on August 30, 2021, from CEO &
President, Michael Feldschuh:
Dear Fellow Shareholder:
I have never been more excited about the
progress of our company or the prospects for our business in the
time ahead. Daxor has been working hard for years as the global
leader in blood volume measurement technology to drive sales and
adoption of our novel FDA-cleared diagnostic in the healthcare
system. The opportunity for our customers is the promise of smart
individualized volume care which substantially improves health
outcomes for patients and the financial and quality outcomes for
hospital systems. The opportunity for our business is to scale into
the total serviceable market of more than ten million tests per
year in the United States alone through organic growth,
partnership, and joint ventures. In 2022, Daxor plans on launching
its new point-of-care blood volume analysis systems, developed
under multiple contracts by the US Department of Defense (US DOD),
a significant leap forward in our market-leading technology and the
most important product launch in 20 years for the company. Our new
systems are planned to be three times faster, simpler, and as
announced in March of this year will have an option for a novel
fluorescing marker as well as a nuclear tracer for use in new care
settings beyond our current systems.
To realize that promise and the enormous market
potential for our products requires the company to execute on three
key areas of performance: strong commercialization, next-generation
product development, and continued clinical outcomes. I am pleased
to report that in the first half of 2021 we have made important
breakthroughs building on our focus in each of these key areas.
Beginning with financial performance, the
Company is pleased to report a 26.5 percent increase in the
unaudited revenues of our blood volume diagnostic operating
division for the six-month period ended June 30, 2021, as compared
to the same period in the prior year. Revenue growth was driven by
a combination of the sale and leasing of our capital equipment to
hospitals and orders for our single-use blood volume diagnostics
kits for heart failure management, critical care use, as well as
other indications. Additionally, revenue accrued from the US DOD
orders as well as third-party companies contracting with Daxor to
conduct blood volume analysis on their products. As of this date,
the Company year-to-date has sold, leased, placed devices for
research, or opened new reference lab accounts with eight new
clients in addition to focusing on growing business at the existing
install base. Many of these new accounts are just beginning to ramp
up as they integrate the diagnostic into their treatment
protocols.
At June 30, 2021, Daxor had net assets of
$14,493,285 or $3.59 per share. For the six-month period ended June
30, 2021, Daxor had net dividend income of $120,878, net realized
gains on investment activity of $41,822 There was a net change in
the unrealized appreciation on investments, options and securities
borrowed of $279,396 as markets improved from the beginning of the
recovery from the COVID-19 pandemic. There was a net realized loss
from the operating division relating to spend on research,
development, sales and overhead of $1,546,987 as the Company
continues to invest judiciously in research and development for our
2022 product launch, to ramp commercial sales teams, as well as
production facilities for our next generation blood volume
analyzers.
Accelerating commercialization is a priority for
Company management, and in this area Jean Oertel, has been promoted
to Senior Vice President of Commercialization in recognition of the
strong program to build our sales organization. Jean, a veteran
from both Medtronic and Sensionics, has focused on recruiting top
talent to the sales and clinical support team. Importantly, Daxor
entered into agreements in the first half of this year with two
distributors to amplify the reach of our products at hospitals not
covered by Daxor’s own reps. Management anticipates that there will
be sales force of over 50 composed of Daxor’s territory managers,
clinical support team, and third-party distributor reps backed by
Daxor’s internal marketing team. The Company has never had a
capability of this size before, and the highly efficient hybrid
internal team/distributor model allows us to scale without the
capital investment and overhead that such a large sales force would
otherwise entail.
Equally important is the progress that Daxor has
made in the area of clinical outcomes utilizing our blood volume
analyzer systems. In May of this year Management announced a
landmark grant from the National Institutes of Health (NIH) awarded
to Daxor and investigators at the VA Hospital system for a
prospective randomized multi-center blood volume trial for the
treatment of heart failure (HF) with Daxor’s systems. This
multi-phase study has already begun and will add to the significant
evidence of the impact of blood volume guided care in reducing HF
readmissions and mortality. Receiving funding from the NIH and
partnering with the VA system is just one of the many ways that
Daxor is advancing its business in a capital-efficient and
effective manner, these grants are extremely competitive, and
Management sees this award as significant validation of its
technology and blood volume’s clinical significance.
The Company also announced in August that a
promising research letter on the use of Daxor’s BVA-100 analyzer on
six COVID-19 patients at NYU Medical center had been published in
the prestigious Journal of Critical Care. Daxor’s prospective
multi-center trial has enrolled more than 50% of its goal and
results are expected later this year. The research letter showed a
strong need for the BVA-100 to help manage COVID-19 optimally.
Management looks forward to sharing the results of the multi-center
trial when they become available.
Other research published in the first half of
2021 was presented at the Society for Critical Care meeting showing
the value of blood volume analysis in transfusion practice. Data in
the use of blood volume for measuring the impact of salt and volume
adjustment to treat postural orthostatic hypertension (POTS) was
published in the Journal of the American College of Cardiology, —
syncope and POTS are significant additional growth areas for the
Company in the future. Previously announced research trials with
Duke University in HF treatment and collaborations with Nuwellis
Corporation are on track after suffering delays related to COVID
last year as conditions at hospitals allowed enrollment to
continue.
The third area of focus of the company has been
the vital research and development of next generation Blood Volume
Analyzers (BVA). In March of this year Daxor announced that the US
DOD had awarded an additional $750,000 contract for BVA systems for
both military and civilian use utilizing a novel patent-pending
fluorescent tracer under development by Daxor since 2018. The US
DOD and the Center for Advancing Point of Care Technology (funded
by NIH) have awarded the Company an additional four contract awards
for Daxor’s next generation blood volume analyzer. The next
generation device is designed to be portable, three times faster,
simpler, and able to operate in areas where a test requiring a lab
to analyze results is just not practical. Daxor was awarded these
highly competitive contracts on the basis of its proposals showing
not only revolutionary technology but also our ability to
successfully develop and commercialize diagnostics in this area
where the company has over 40 years of experience as the global
leader in Blood Volume analysis technology. The company applied for
6 new patents in 2020 covering aspects of the new system as well as
further applications of blood volume measurement and its treatment
paradigms. Management anticipates that a similar number of new
patents will also be filed in 2021 as R&D accelerates and new
technologies are being developed based upon contracts that have
been awarded and partnerships with 3rd party technology
accelerators have been signed. The Company has added engineering,
scientific, and production personnel to accelerate the development
of new products at its highly-cost effective Oak Ridge, Tennessee
facility instead of out-sourcing to expensive and slower contract
research organizations and anticipates that investment in this area
will accelerate this fiscal year as we develop highly valuable,
patentable technology to drive growth and partnerships in years to
come.
Management anticipates that there will be
significant interest and uptake of the new systems based upon
preliminary discussions with clinicians helping to develop the
technology. Daxor’s next generation devices will also be eligible
for Phase III funding awards and acquisition by branches of the
military for their deployment to aid in combat casualty care.
The strong trend of healthcare is toward
individualized care and cost-effectiveness. Our BVA diagnostic is a
non-invasive, inexpensive, and rapid blood test which allows care
teams to solve the significant challenge of accurately managing the
fluid levels of patients, whether it is in the heart failure clinic
or the ICU, and studies published and presented are proving just
how exciting the potential for this approach is. Reducing
mortality, lowering complications, reducing hospital resource use
and length of stay with a non-invasive and 98% accurate test is
achievable with our patented technology. Just as exciting is the
next generation of products that are in our development pipeline
slated for completion this year which should further enhance the
accessibility of our test and open it up to both government as well
as civilian hospital systems on an international scale.
Daxor has been reporting as an investment
company under the Investment Company Act of 1940 since January 1,
2012. See the Notes to the Financial Statements of Form N-CSR for
further information on Daxor’s strategies and goals regarding its
investments in publicly traded securities, to help fund its
diagnostic operations. Because of its significant holding of
publicly traded securities, the SEC currently classifies Daxor as a
closed-end investment management company with a fully owned medical
operating division; however, the primary focus of management is on
our operational objectives. Daxor anticipates that as the value of
the operating company continues to increase as a percentage of
assets owned, it will be eligible to file under its previous
designation as an operating company and report as an operating
company and will take steps to accomplish this result.
Any shareholder who is interested in learning
more about our medical instrumentation and biotechnology operations
should visit our website at www.daxor.com or contact our
investor relations representative Bret Shapiro of CORE IR at
516-222-2560 for more detailed information. We periodically issue
press releases regarding research reports and placements of the
BVA-100 Blood Volume Analyzer in hospitals.
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Cordially Yours,
Michael FeldschuhCEO and President
About Daxor
CorporationDaxor Corporation (NYSE: DXR) is the
global leader in blood volume measurement technology focused on
blood volume testing innovation (organized as an investment company
with fully owned innovative medical instrumentation and
biotechnology operations). We developed and market the BVA-100®
(Blood Volume Analyzer), the first diagnostic blood test cleared by
the FDA to provide safe, accurate, objective quantification of
blood volume status and composition compared to patient-specific
norms. The BVA technology enhances hospital performance metrics in
a broad range of surgical and medical conditions, including heart
failure and critical care, by informing treatment strategies,
resulting in significantly improved multiple measures of patient
outcomes. Daxor's mission is to advance healthcare by enabling
optimal fluid management with blood volume analysis. Daxor’s vision
is optimal blood volume for all. For more information, please visit
our website at Daxor.com.
Forward-Looking
StatementsCertain statements in this release may include
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including without
limitation, statements regarding the impact of hiring sales staff
and expansion of our distribution channels. Forward-looking
statements are predictions, projections and other statements about
future events that are based on current expectations and
assumptions and, as a result, are subject to risks and
uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
release, including, without limitation, those risk associated with
our post-market clinical data collection activities, benefits of
our products to patients, our expectations with respect to product
development and commercialization efforts, our ability to increase
market and physician acceptance of our products, potentially
competitive product offerings, intellectual property protection,
FDA regulatory actions, our ability to integrate acquired
businesses, our expectations regarding anticipated synergies with
and benefits from acquired businesses, and additional other risks
and uncertainties described in our filings with the SEC.
Forward-looking statements speak only as of the date when made.
Daxor does not assume any obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor Relations ContactBret
ShapiroSr. Managing Partner, CORE
IR516-222-2560brets@coreir.com
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