Oak Ridge, TN, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: 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 25, 2022, from CEO & President, Michael Feldschuh.
August 25, 2022
Dear Fellow Shareholder:
It is my pleasure to report on Daxor’s first six months results for the period ended June 30, 2022. I have written to shareholders in the past, that for the company to realize the tremendous potential of its paradigm-shifting medical technology, we need to execute well in several key areas. Clinical results showing strong outcome improvement must be accompanied by commensurate health economic outcomes to justify adoption. New research milestones showing the value of our unique diagnostic systems must be paired with next-generation equipment that offers the ability to easily adopt our technology into the clinical workflow. The promise of our systems must be supported by engagement with our customers through clinical support, medical education, and a well-run sales support team. I am pleased to report that in the past 6 months, we have made important breakthroughs building on our focus in each of these key areas – balancing our growth in commercialization with strategic investment fueling the development of our next generation systems in preparation for the most important technology launch for the company in twenty years.
Starting with the unaudited parent company results as of June 30, 2022, Daxor’s net assets increased 35.3% to $19,615,712 or $4.85 per share as compared to $14,493,285, or $3.59 per share at June 30, 2021. Daxor’s net assets decreased 7.3% to $19,615,712, or $4.85 per share as compared $21,152,719 or $5.24 per share at December 31, 2021 – however these numbers do not reflect any change of the valuation of the Operating Division at June 30, 2022. The valuation of the Operating Division remained at $16,500,000 at June 30, 2022, the same value as December 31, 2021 as the valuation of the Operating Division is traditionally performed on an annual basis at the conclusion of the fiscal year. For the six-month period ended June 30, 2022, Daxor had net dividend income of $130,943, net realized gains on investment activity of $1,370,610. There was a net decrease in the unrealized depreciation on investments, options and securities borrowed of $1,367,276 as we sold positions during the second quarter of 2022 prior period’s significant unrealized gains unwound into realized gains for the period. Included in the Net Decrease in Net Assets Resulting from Operations of $1,812,497 is non-cash stock-based compensation expense of $275,490, 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 $1,535,071 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 2022/2023 product launches, ramping the commercial sales teams, as well as production facilities for our next generation blood volume analyzers.
Our net asset value (NAV) has risen strongly in the last year and the operating business is experiencing exciting growth and development — increasing revenues from commercialization, great progress in research and development for our next-generation systems set to launch at the end of Q4 and beginning of Q1 2023, and the growing body of clinical evidence from leading research centers on 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.
At the operating division level, the past 12 months have been pivotal in the growth of the company and its business prospects. Our operating division has been experiencing strong growth in sales, revenue, and new customer acquisition while our research and development efforts have been accelerating the development of our next generation blood volume analyzer systems. The Company is pleased to report a 92.6 percent increase in the unaudited revenues of our blood volume diagnostic operating division for the six-month period ended June 30, 2022 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 along with a 9.2% price increase that was well received by the market. Additionally, revenue growth was driven by the United States Department of Defense (DOD) orders as well as third-party companies contracting with Daxor to conduct blood volume analysis on their products.
The Company also reported that the number of Volumex diagnostic kits sold rose 49.4% in the first half of 2022 compared to the first half of 2021. Growth is being driven both by an increase in sales at existing accounts as well as acquisition of new accounts. The company feels that there are still substantial growth opportunities at existing accounts as there is room for growth from winning a higher percentage of patients within existing departments as well as expanding to other departments within the hospital where devices are present.
As of this date, the Company for 2022 has sold, leased, placed devices for research, or opened new reference lab accounts with twelve new clients. Many of these new accounts are just beginning to ramp up as they integrate the diagnostic into their treatment protocols. 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.
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 and we anticipate significant benefit in building awareness for the Company’s products with this important customer base as a result of this affiliation.
The Company is also pleased to report that it successfully completed its US DOD Phase II ARMY contract to develop a next-generation portable point-of-care blood volume analyzer on time and to expectations. This contract specified the creation of a device that is now undergoing evaluation by the FDA for 510(k) approval. Daxor has already submitted preliminary data design questions to FDA and anticipates a full 510(k) package for submission in Q4 with an expected 90-day review period by the agency. Importantly, Daxor’s own currently approved BVA-100 predicate device is the basis for this submission and our engineers have verified and presented to the US DOD that the new unit fully meets their specifications for accuracy, speed, reliability, and capabilities while matching the results of our existing cleared system. Testing has shown that this new system is more than three times faster than our current unit, is capable of giving full results at the bedside without the need for lab services and is the size of a tissue box while weighing about the same as a laptop computer. Management anticipates a commercial launch of the product promptly from notification of clearance and is preparing production to make units available accordingly.
The Company also continues to execute on its AIR FORCE/DOD SBIR Phase II contract which calls for the creation of our next generation non-isotopic tracer. This contract is slated for completion over the next several months (it started later than the USDOD/ARMY contract) and is on-track for successful completion based upon preliminary lab data collected to date. This novel fluorescing marker will extend new care settings beyond our current systems and complement existing product lines.
Management anticipates that there will be significant interest and potential for 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.
To supplement the commercialization of the above products, Daxor also received new support from the National Institutes of Health (NIH) for participation in the 2022 I-CORPS program to facilitate clinical decision support systems for our next generation analyzers. This grant, in addition to offering funding to the company, also gave industry-specific independent management consultancy and offered valuable connections for development of our software systems. These clinical decision support systems will be protected by a patent awarded to the company in January of 2022 covering their novel insights in applying blood volume analysis to optimal treatment pathways and has also resulted in support from the NIH through grants from the Center for Advancing Point of Care Technology.
Equally important is the progress that Daxor has made in the area of clinical outcomes utilizing our blood volume analyzer systems. Institutional Review Board (IRB) approval has been granted and enrollment is underway for two studies of heart failure management (in-patient and outpatient) announced in May 2021 backed by landmark grants from NIH. Investigators at the Geisinger Medical System have completed enrollment in their study and are analyzing data while investigators at the VA Hospital System are actively enrolling patients in their trial. The VA trial of a prospective randomized multicenter blood volume trial for the treatment of heart failure with Daxor’s systems is supported by a clinical decision support system for which Daxor received a landmark method patent in January of 2022. This multi-phase study will add to the significant evidence of the impact of blood volume guided care in reducing heart failure 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 NIH has selected Daxor BVA-100 diagnostic as a metric to track patient health in its COVID long-hauler study in March of this year. This multi-year study will augment the existing data regarding volume derangement and COVID complications and add further to the Critical Care world’s understanding of the virus and its impact on blood volume. 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’s prospective multi-center trial has completed enrollment of COVID patients, and the study has been expanded to include patients with sepsis as well. Management looks forward to sharing the results of the multi-center trial when they become available. One thing we as a society have learned is that COVID-19 and its variants are here for the foreseeable future, and that neither universal vaccination nor social distancing will end the pandemic. If a more deadly and transmissible variant were to emerge, understanding how BVA can reduce mortality in critically ill patients would be urgent.
The first half of 2022 has been another very active period for new research publications highlighting the value and effectiveness of Daxor’s BVA technology to diagnose and improve outcomes in a variety of areas. Several studies highlighting the use of BVA for helping to manage LVAD patients as well as those with implantable hemodynamic devices were presented by clinicians from Duke University Hospital System as well as Methodist Hospital System. We view our technology as giving the key volume data that complements hemodynamic measures and that when used together leads to optimal patient care. Hemodynamics measures pressure, BVA measures volume – these two metrics taken together offer a comprehensive clinical picture.
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.
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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
1-516-222-2560
brets@coreir.com
