Oak Ridge, TN, March 03, 2023 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today issued a corporate update in a Letter to Shareholders filed in its certified shareholder report on Form N-CSR on March 1, 2023 from CEO & President, Michael Feldschuh.
Dear Fellow Shareholder:
Like most of us, I do not look forward to medical tests – needles, stethoscopes, the poking and prodding. Yet, I had the most thrilling test of my life a few months ago as I rolled up my sleeve to receive a dose of Daxor’s blood volume tracer Volumex as part of my participation in the validation of our ground-breaking next generation analyzer. In the testing room at our facility was our current device – a tabletop unit that has reliably computed tens of thousands of tests at leading medical centers, and next to it the new state-of-the-art portable unit, smaller than a shoe box, with an embedded touch screen and a cartridge slot running on battery power. The difference in size was such that you could almost miss the new unit, it being less than 1/10th the size of our current BVA-100. Once the test started, the difference between the two units continued, validating the new unit against our current approved device required my blood to be collected in timed samples and placed in both units. The new unit finished within 2 minutes of the blood collection process, the current unit would not have results for another half hour with additional lab benchwork. Not only was the new unit three times faster than the current unit, but as the results of the tests successfully matched at 99% I felt the admiration for the hard work of our team and the confidence of the U.S. Department of Defense (DOD) which awarded our contract to create this ruggedized, portable unit for combat casualty care as well as civilian use. For us, it is no exaggeration that this next generation analyzer is our most important product launch in twenty years and has the potential to deliver a level of speed, access, and accuracy to fluid management that can broadly change medicine. I will report more on this project below, but first some financial highlights.
It is my pleasure to report on Daxor’s results for the year ended December 31, 2022. For the fourth year in a row our operating business is experiencing continued growth and development — increasing revenues from commercialization, great progress in research and development for our next-generation systems set to launch this year, and a growing body of clinical evidence from leading research centers of the unique value of our diagnostic to save lives and vastly improve health and hospital economic outcomes. 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.
I have written in the past that 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 2022 we made important breakthroughs building on our focus in each of these key areas.
As of December 31, 2022, Daxor’s net assets were $28,969,469 or $6.75 per share as compared to $21,152,719, or $5.24 per share at December 31, 2022. This 36.95% increase in the net asset value is primarily due to the continued appreciation in value in the Operating Division. The valuation of the Operating Division increased $9,500,000 to $26,000,000 on December 31, 2022. For the year ended December 31, 2022, Daxor had net dividend income of $223,916, and net realized gains on investment activity of $2,679,421. There was a net decrease in the unrealized appreciation on investments, options and securities borrowed of $2,763,895 as we sold positions during the 2022 prior period’s significant unrealized gains unwound into the gains for the period. Included in the Net Increase in Net Assets Resulting from Operations of $5,178,133 is non-cash stock based compensation expense of $786,642, in an effort to provide incentive to employees, officers, agents and consultants through proprietary interest in the company. There was a net realized loss of $3,264,419 from the operating division relating to spending on research, development, sales and overhead as the Company continues to invest judiciously in research and development for our 2023 product launch, ramping the commercial sales teams, as well as production facilities for our next generation blood volume analyzers.
Focusing further on the operating division financial performance, the Company is pleased to report a 20.5 percent increase in the unaudited revenues of our blood volume diagnostic Operating Division for the year ended December 31, 2022 as compared to 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. The unaudited revenue from single-use test kits rose by 59.5% compared with 2021 driven by increasing usage at existing accounts as well as the addition of 18 new accounts for the year (as compared to 11 new accounts in 2021). Additionally, revenue accrued from the U.S. 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 for 2022 has sold, leased, placed devices for research, or opened new reference lab accounts with eighteen new clients and has installed or has orders to install an additional five accounts in Q1 of 2023. Many of these new accounts are just beginning to ramp up as they integrate the diagnostic into their treatment protocols and the need for our product has never been greater – heart failure patients are set to rise from the current 6 million to more than 8 million in the next six years as the baby boom generation ages and hospitals are under increasing pressure to improve outcomes and contain costs.
In 2023 Daxor plans on launching its program of new point-of-care blood volume analysis systems, developed under multiple contracts with the U.S. DOD as well as grants from the National Institutes of Health (NIH), a significant leap forward in our market-leading technology. Daxor developed this unit under contract from the U.S. DOD and successfully demonstrated in 2022 a manufacture-ready prototype that was specified to be equivalent to the current 510(k) cleared BVA-100 unit in terms of accuracy and capabilities. This new system has been measured to be three times faster, simpler, battery powered and capable of being a full point-of-care CLIA-waived device. Development for a model utilizing a novel fluorescing marker is also ongoing under U.S. DOD contract for use in new care settings beyond our current systems. Daxor met with the FDA in the fall of 2022 to discuss its pre-submission data for a 510(k)/CLIA dual pathway. Management was able to ask questions and receive guidance from the agency on a validation plan and application pathway to satisfy regulatory requirements. Daxor is currently executing on the validation of the prototype systems with clinical partners to satisfy FDA standards and intends to submit its application with a goal of receiving approval by the middle of 2023. Management feels that the requirements are straight-forward and the technology as demonstrated to the U.S. DOD meets the standard for approval, thus a careful validation study and thorough application to the civilian FDA has a promising trajectory. Driving this important project is our new Vice President of Project Management, Linda Cooper - she is a seasoned professional with a background in bio-engineering as well as extensive regulatory experience with the FDA.
Management anticipates that upon approval there will be significant interest and uptake of the new systems based upon preliminary discussions with clinicians helping to develop the technology as well as an increase in disposable kit sales driven by the speed and convenience of the new system. 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 as well as further development contracts. Daxor has several applications for contract work with the U.S. DOD pending or in the planning stage as well as grant proposals for substantial research studies under review with agencies at the NIH. These contracts provide important sources of non-dilutive funding, further technology development, and additional clinical validation which drives adoption of our diagnostic.
Accelerating commercialization is a priority for Company management, and in this area Senior Vice President Jean Oertel, a veteran from both Medtronic and Sensionics, has focused on recruiting top talent to the sales and clinical support team adding new territory managers/clinical support reps to the team to support the strong growth in accounts. In addition to building our internal team, Daxor has also entered into strategic partnerships with the Heart Failure Society of America and The Society for Nuclear Medicine and Molecular Imaging. These organizations are helping our team to connect to thought leaders and promising new accounts and research collaborators. To further drive adoption, Daxor has also been named an Industry Partner with the premier global cardiology consulting company MedAxiom, a wholly owned subsidiary of the American College of Cardiology. MedAxiom connects over 450 leading cardiovascular organizations to a select group of companies with novel solutions in the cardiac space. Daxor has been presenting at their premier events, benefiting from hosted webinars on our product that they produce, and benefited from their building awareness for the Company’s products with their important customer base as a result of this affiliation.
Our Company, like much of the world, has faced increased costs due to inflation. To offset this Daxor has announced an increase of 8.4% for our disposable Volumex kits to $385 per test starting at the end of Q1 of 2023. The current reimbursement for our product has also risen as we have updated our prices and we have worked with Medicare Administrative Contractors (MAC) to ensure that our new prices are reflected in their price guides.
Equally important is the progress that Daxor has made in the area of clinical outcomes utilizing our blood volume analyzer. The company anticipates the results of a pilot Randomized Control Trial (RCT) in heart failure patients with BVA guided treatment to be released at the end of Q1 of 2023 by researchers from the Duke Clinical Research Institute. This trial is in addition to ongoing Phase I RCT work at two Veterans Administrative hospitals under NIH funding as well as an outpatient prospective trial being conducted at Geisinger Medical Center. Over the course of 2022, over a dozen new research studies on BVA were published in peer-reviewed journals or at society conferences. These studies importantly highlighted that BVA can reduce hospital length of stay by 2.5 days on average for heart failure patients, a very significant savings while also improving clinical outcomes. Data on the value of BVA for use in LVAD patients and its superiority to pressure-based cardiac implantable devices are also highlights of data that researchers from a variety of institutions published. With regard to recognition and awareness of these developments, a landmark session at the Heart Failure Society of America 2022 Annual Meeting was attended by hundreds of physicians which posited that Daxor's BVA provided uniquely valuable data for congestion management, superior utility to existing standards of care of pressure-based measures, and that further study and adoption of it was supported by the growing body of evidence. A session of this nature — comparing volume versus pressure measures -- was never presented before, and Management was very pleased at the strong and supportive reception that our technology received at this event which was not sponsored by Daxor in any way.
The Company also announced in August 2021 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 launched a prospective multi-center trial on the back of that data which has been expanded to incorporate not only COVID patients but sepsis patients as well. The COVID arm has completed enrollment and the sepsis comparator arm should be completed in the coming quarter with publication to follow. Management looks forward to sharing the results of the multi-center trial when they become available. A substantial expansion of the Company's revenue in the area of critical care medicine could be driven by a combination of the new data, new funding opportunities the data will open up, as well as our next-generation analyzer which promises a speedy workflow that is compatible with the needs of this specialty.
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 (outpatient) or the hospitalized heart failure patient or in 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. In the competitive area of healthcare, having achieved reimbursement for our technology for both inpatient and outpatient use is a strong competitive advantage that will drive our adoption in step with our increasing clinical evidence and commercial teams. 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.
In order to sign up for electronic delivery of shareholder reports and prospectuses, please send an email to info@daxor.com. If you do not hold your account directly with Daxor, please contact the firm that holds your account about electronic delivery.
Cordially Yours,
Michael Feldschuh
CEO and President
About Daxor Corporation
Daxor Corporation (Nasdaq: DXR), is the global leader in blood volume measurement technology focused on blood volume testing innovation. 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. Over 60,000+ tests have been performed at leading hospital centers across the U.S., enhancing hospital performance metrics in a broad range of surgical and medical conditions, including significantly reducing mortality and readmissions in heart failure and critical care. Daxor has several ongoing multicenter trials in the areas of COVID-19 and heart failure treatment with support from the NIH and is under contract developing analyzers to improve combat casualty care with the U.S. Department of Defense. 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 Statements
Certain 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 Contact:
Bret Shapiro
Sr. Managing Partner
CORE IR 516-222-2560
brets@coreir.com
