Pilot Randomized Controlled Trial Validates Daxor BVA-100® Diagnostic for Heart Failure Patients
Daxor Corporation (NYSE: DXR) has announced promising new data from a pilot randomized control trial validating the accuracy of its BVA-100 diagnostic in managing heart failure therapy. The study, conducted at Duke Heart, highlighted a potential reduction in hospital stay by 2.7 days (P<0.09) for patients receiving BVA-guided care. The results, presented at the Technology Heart Failure Therapeutics Conference, indicated a significant discrepancy between physician assessments and BVA results. Daxor aims to leverage this data to support larger-scale clinical studies, reinforcing the effectiveness of blood volume analysis in improving heart failure treatment outcomes.
- Pilot RCT indicates BVA-100 may reduce hospital stay by 2.7 days.
- Research suggests BVA-guided care is more accurate than standard assessments.
- Support for future funding of large-scale studies based on positive pilot results.
- Trial was not powered for clinical endpoints, limiting definitive conclusions.
BVA Feasibly Guides Fluid Management with Greater Accuracy than Traditional Means
Researchers Conclude that a Larger Powered RCT is Warranted
Oak Ridge, TN, March 23, 2023 (GLOBE NEWSWIRE) -- Daxor Corporation (NYSE: DXR), the global leader in blood volume measurement technology, today announces new pilot randomized control trial (RCT) data from Duke Heart validating the greater accuracy of the Company’s BVA-100 diagnostic in optimizing decongestion therapy for heart failure patients and pointed to a strong signal toward reducing hospital length of stay in a pilot cohort of 31 patients. Data were presented as a moderated featured abstract at the Technology Heart Failure Therapeutics Conference, which focuses on device and technology-based treatments in heart failure, held March 20-22, 2023 in Boston, Mass.
Blood volume analysis (BVA) was used in hospitalized heart failure patients to study the effects of BVA-guided care on decongestion therapy and outcomes versus standard of care. In both study arms, patients had BVA testing within a day of admission and one day prior to discharge, along with physician assessment for congestion. Study results showed little to no correlation between physician assessment of congestion on admission compared to BVA results, and those that received BVA-guided treatment had a strong trend toward lower total hospital length of stay (2.7 fewer days, P<0.09). “Until we measure blood volume, we really don't know if patients have a normal blood volume or not. BVA testing done early during hospitalization is feasible and helps clinicians get to the right treatment decision earlier,” said Marat Fudim, M.D., principal investigator and presenter.
Jonathan Feldschuh, Daxor’s Chief Scientific Officer continued, “This pilot study, which was not powered for clinical endpoints but rather feasibility and demonstration of clinical need, exceeded all expectations. Heart failure management is centered around precise volume and red cell management, and this first-of-its-kind RCT adds further validation that surrogate markers such a physical exam are not accurate for volume assessment in over
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 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
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