Oak Ridge, TN, March 04, 2025 (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 04, 2025 from CEO & President, Michael Feldschuh.
Dear Fellow Shareholder:
"Behind every overnight success is a decade of relentless work that nobody saw." — Anonymous
As we forge ahead into this pivotal year, Daxor remains laser-focused on our mission, unwavering in our execution of strategic goals, and fueled by the relentless determination for transformative growth and adoption of our technology. 2024 was remarkable for the company, solidifying our position as the global leader in blood volume measurement technology. In every area during 2024 and the strong start of 2025, management is pleased to report the substantial progress for the company -- in revenue growth, new customer acquisitions, increasing utilization of our products by existing customers, strategic agreements to acquire a key supplier, next generation systems under Food and Drug Administration (FDA) review, positive clinical studies, new patents granted and pending, successful National Institutes of Health (NIH) grant awards, Department of Defense (DoD) contracts awarded, and further research and development for groundbreaking products set to launch in subsequent fiscal years. I will detail below more in these areas but first wish to review why our company’s vision is to commercialize the products that enable optimal blood volume for all patients.
Our Mission: Advancing Healthcare By Enabling Optimal Fluid Management With Blood Volume Analysis
Daxor is focused on profoundly improving outcomes for tens of millions of patients as well as the hospital systems and the payers which support the system, by solving a central problem of medicine – providing highly accurate, convenient, and rapid knowledge of patient blood volume. Managing blood volume is the cornerstone of care for some of the largest areas of patient care – heart failure, sepsis, post-surgical blood loss and syncope to name a few – but this urgent medical need has long been hampered using proxy or surrogate markers, and not direct measurement of the blood volume. Many of these markers are costly, some are invasive, and none are accurate in contrast to Daxor’s 98% accurate system. Care teams cannot effectively treat what they do not correctly diagnose, so our rapid,accurate diagnostic test is a game-changer. Every metric that matters is impacted from this first principle of accurate diagnosis. Patients receiving optimal care are treated more quickly with better outcomes,have a shorter length of stay in the hospital, suffer fewer costly readmissions, and have lower mortality and fewer complications overall. This leads to better results for patients, hospitals, and insurers on both a health and economic level.
As of December 31, 2024, Daxor’s net assets were $36,789,893 or $7.25 per share as compared to $34,010,384, or $7.08 per share on December 31, 2023. The 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 $3,500,000 to $35,500,000 on December 31, 2024. For the year ended December 31, 2024, Daxor had a net dividend income of $104,115, net realized gains on investment activity of $1,359,163. There was a net decrease in the unrealized appreciation on investments, options and securities borrowed of $1,148,350. As we sold positions during 2024, 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 $533,926 is non-cash stock-based compensation expense of $1,245,583, to provide incentive to employees, officers, agents, and consultants through proprietary interest in the company. There was an investment of $1,614,124 into 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 2025 product launch, ramping the commercial sales teams, as well as production facilities and inventory for our next generation blood volume analyzers.
The following financial highlights are from our Unaudited Operating Division:
Operating division met its goal of achieving cash-flow break even during Q1 of 2025, not including costs from stock-based compensation, depreciation, amortization, or capex
Revenue increased 116.5% year on year for 2024 versus 2023
Revenue in the first 2 months of 2025 has increased over 100% year on year versus 2024
Number of kits sold for our Diagnostic System rose 60.1% year on year for 2024 versus 2023
12 New Accounts signed in 2024, including five who purchased analyzers, the balance was a combination of sales, rentals, and ezBVA Lab services
3 New Accounts signed in the first 2 months of 2025, with a combination of placement agreements and ezBVA Lab services
The operating company increased revenues from the second half of 2024 through additional contracts from the DoD, receiving a 2 year, $2.5M contract as matching funds award from our capital raise in 2023, with monthly payouts for the duration of the contract
Additional funding awards from Launch Tennessee and the National Institutes of Health in the form of direct grants totaling more than $350K
FDA reviewed the 510(k) submission for our next-gen analyzer, Daxor has successfully completed additional testing data requested and will file a resubmission imminently
Daxor entered into an agreement to acquire the IP from its supplier to bring manufacturing entirely in-house for its Volumex product and to add Glo-fil in addition to its product offerings
The first two months of 2025 are off to an even faster pace of growth on all fronts versus 2024 as we see an acceleration of adoption and use of systems even prior to the launch of our next generation systems, February was a record-setting sale of monthly kit revenue.
Next Generation Blood Volume Analyzer System
Daxor completed a multi-center study to validate its next generation blood volume analyzer in Q4 of 2023 and submitted it for review with the FDA at year-end under a 510(k)/Clinical Laboratory Improvements Amendments (CLIA) - waiver dual submission pathway. Following the statutory six-month review for this dual submission, FDA requested additional information to supplement the application. Daxor elected to re-file this submission as a single 510(k) for a 90-day review pathway with the intention to file a separate CLIA study in the future. This pathway is simpler and significantly reduces the amount of supplemental information the company needs to produce to get an approved product. With the supplemental studies now complete, Daxor intends to file the new application imminently.
This point-of-care blood volume analysis system, developed under multiple contracts with the DoD, as well as grants from the NIH, is a significant leap forward in our market-leading technology, allowing for a blood volume determination at the bedside in as little as fifteen minutes. This new system has been validated in our study to be three times faster, simpler, battery powered, and capable of being a full point-of-care CLIA-waived device. Daxor intends to first secure 510(k) approval for the device to market at its current CLIA-designation of moderate complexity and to conduct further CLIA studies to show that it is approvable for a CLIA-waived designation in a second developmental phase later this year. 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 and find acceptance into workflows at a much greater level than our current lab-based system.
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. The speed and convenience of the new system will open additional points of use in both the hospital and outpatient settings. Indications such as critical care, where the speed of results is paramount, should see significant growth as a result. 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.
Strategic Acquisition and New Product Launch of an Additional Diagnostic Radiopharmaceutical
Daxor Corporation entered into a definitive agreement with our supplier in March of 2024 to acquire exclusive, worldwide rights and intellectual property to manufacture Volumex and Megatope from Iso-Tex Diagnostics, along with exclusive rights to Glofil, a drug that measures glomerular filtration rate (GFR). The acquisitions are expected to be immediately cash flow positive and accretive to earnings due to internalized production and higher margins. Daxor plans to bring the manufacturing of these diagnostics in-house to its Oak Ridge facility, which will increase margins on its blood volume analysis (BVA) test kits. Acquiring Glofil provides Daxor with a new product to cross-sell to its growing customer base, particularly in hospitals where Glofil is already used. The deals are structured with favorable seller-provided financing, with payments not due until the manufacturing transition is completed in 6-9 months, followed by monthly installments for two years. The transaction is subject to regulatory approvals and other customary conditions.
Further Research, Patents, and Clinical Outcomes
From Q1 of 2024 through the first two months of Q1 of 2025 research utilizing BVA has appeared in more than a dozen peer-reviewed conferences or publications. The data has highlighted the utility of BVA in cardiorenal syndrome, uncovering often-missed diagnosis of heart failure patients, and the superiority of BVA versus commonly used proxy measures. It is a key strategy of the company to continue our efforts to encourage not only clinical use, but also the academic study of the health and health economic outcomes from BVA. At the root of better outcomes is the best diagnosis of the patient – something which BVA has shown to be uniquely capable.
Summary
The strong trend in 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, 98% accurate diagnostic is achievable with our patented technology. In the competitive area of healthcare, having achieved reimbursement of our technology from both public and private payers 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 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 has increased significantly relative to the percentage of listed security assets owned, it will be eligible to file under its previous designation as an operating company. The goal for management is to secure this designation before the end of 2025.
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 acquisitions of our BVA technology by customers.
For more information, please visit our website Daxor.com. Sign up to receive news on Daxor’s innovative technology and investor announcements HERE.
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 only 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 65,000+ 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 trials in the areas of 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. Sign up to receive news on Daxor’s innovative technology HERE.
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
