New Randomized Controlled Trial Demonstrates the Efficacy of Daxor’s BVA Guided-Care in Heart Failure Patients

Rhea-AI Summary

Daxor Corporation (Nasdaq: DXR) Announces Positive Results from NIH-Sponsored Study at AHA Annual Meeting

Positive

• Successful pilot study validates the effectiveness of Daxor's BVA-100® diagnostic blood test in guiding treatment decisions for acute decompensated heart failure patients
• BVA-guided treatment protocol significantly improves volume-appropriate care for patients
• Data demonstrates the inaccuracy of clinical assessment in diagnosing volume status and anemia in ADHF patients

Negative

• None.

Data From Study Funded by NIH Presented at the American Heart Association Annual Meeting

Oak Ridge, TN, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces the presentation of data from a Phase I National Institute of Health (NIH) sponsored randomized control trial (RCT) from two Veterans Affairs Medical Centers (Boston , Minneapolis), validating treatment decisions guided by the Company’s BVA-100^® diagnostic blood test benefitted patients with acute decompensated heart failure (ADHF). Data were presented at the American Heart Association Scientific Sessions 2023 at the Pennsylvania Convention Center in Philadelphia, PA on November 11, 2023.

Key findings included:

• This successful pilot study paves the way for further funding opportunities tied to a Phase II project now that both the need for blood volume analysis (BVA) and the practicality of applying its results has been demonstrated
• Data showed that on average 7 out of 10 ADHF patients are not being accurately diagnosed. BVA was more accurate than clinical assessment which was correct only 53% for volume and 56% for anemia
• A BVA-guided treatment protocol was successfully incorporated into the clinical workflow for ADHF
• Volume-appropriate treatment was significantly more likely in patients who received BVA-guided care showing that the results of BVA can be applied by clinicians in real-time in the clinical setting

The study titled, “Clinical Assessment of Volume Status in Heart Failure is Inaccurate at Detecting Hypervolemia and Anemia as Quantified by Blood Volume Measurement,” prospectively compared the standard of care treatment decisions (n=16) to those in a BVA-guided fluid management protocol (n=16). Clinical assessments of volume status and anemia were collected for all patients prior to BVA measurement at hospital admission and post-discharge.

The results showed that the accuracy of volume status and anemia as determined by clinical assessment was only 53% and 56%, respectively, compared to BVA indicating that approximately 7 out of every 10 patients did not receive an accurate diagnosis of their volume condition. “Volume management of both plasma and red blood cell volume is the cornerstone of heart failure care, and that care must start with an accurate diagnosis of the underlying problem which this data indicates does not happen in the vast majority of cases. This data confirms other RCT pilot data that was independently presented by researchers from Duke University earlier this summer,” noted Jonathan Feldschuh, Daxor’s Chief Scientific Officer.

Patients in the BVA-guided arm received treatment informed by the BVA test results, in the blinded arm volume was only assessed using clinical tools and biomarkers absent the BVA results. “We successfully embedded a BVA-guided treatment protocol into the clinical workflow of ADHF,” said Jacob Joseph, M.D., and principal investigator. “We demonstrated that treatment decisions could be guided by BVA, with volume-appropriate treatment significantly more likely in the BVA arm than in the usual care arm.”

Michael Feldschuh, Daxor’s CEO and President said, “This study provides further evidence that our BVA technology is a practical and effective solution to the challenge of optimizing heart failure care and use of our diagnostic confirms that surrogate markers such a physical exam are not accurate or precise compared to direct and objective measurement with Daxor’s BVA system. We are grateful for the precise and capable work of the independent investigators who led this project and the support of the NIH who have recognized the significant opportunity that BVA represents to improve the care of heart failure patients.”

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

FAQ

What were the key findings of the study presented at the AHA Annual Meeting?

The study validated the effectiveness of Daxor's BVA-100® diagnostic blood test in guiding treatment decisions for acute decompensated heart failure patients. It also demonstrated the inaccuracy of clinical assessment in diagnosing volume status and anemia in ADHF patients.

How accurate was the BVA in comparison to clinical assessment?

BVA was more accurate than clinical assessment, which was correct only 53% for volume and 56% for anemia.

What were the implications of the study results for heart failure care?

The study provides evidence that BVA technology is a practical and effective solution to the challenge of optimizing heart failure care, offering a more accurate and precise measurement compared to traditional clinical tools and biomarkers.

What were the key outcomes of the BVA-guided treatment protocol?

The BVA-guided treatment protocol significantly improved volume-appropriate care for patients with acute decompensated heart failure, showing that treatment decisions could be guided by BVA, leading to better outcomes for patients.

How did the study findings impact the future of blood volume analysis?

The successful pilot study paves the way for further funding opportunities tied to a Phase II project, indicating the potential for continued advancements in blood volume analysis for heart failure care.