Daxor Unveils New FDA-Cleared BVA Analyzer Amid Strong Market Demand and Pivotal Clinical Data at HFSA

Rhea-AI Summary

Daxor Corporation (Nasdaq: DXR) unveiled its newly FDA-cleared next-generation Blood Volume Analysis (BVA) analyzer at the Heart Failure Society of America (HFSA) Annual Scientific Meeting. The new system features enhanced ease of use, speed, and over 95% accuracy.

Three pivotal studies from leading institutions validated BVA technology's effectiveness: Banner University Medical Center reported zero unplanned hospital admissions for optimally managed patients, Wellstar Health System demonstrated improved LVAD outcomes with increased survival rates and reduced readmissions, and Geisinger Medical Center confirmed BVA's utility in diagnosing Cardiac Amyloidosis.

Insights

Medical Device & Healthcare Market Analyst

Daxor's new FDA-cleared BVA analyzer shows strong clinical validation with zero readmissions in optimally managed patients, positioning for significant market capture.

Daxor's newly FDA-cleared blood volume measurement analyzer represents a significant commercial advancement for the company, addressing a multi-billion-dollar market opportunity in fluid management for heart failure patients. The system's enhanced ease of use, speed, and over 95% accuracy directly addresses clinical workflow barriers that typically slow medical device adoption.

The three clinical studies presented at HFSA provide compelling validation across high-cost patient populations where fluid management is critical. Most notably, the Banner University Medical Center study revealed that patients with optimal blood volumes had zero unplanned hospital readmissions versus 57-77% readmission rates in patients with imbalances. This represents potential for significant cost savings, as heart failure readmissions remain one of healthcare's most expensive recurring costs.

The Wellstar study demonstrates meaningful clinical outcome improvements in LVAD patients, with increased survival rates (30-day survival from 90.3% to 93.6% and 1-year survival from 79.6% to 87.8%) and reduced 30-day readmissions (from 28.6% to 18.5%). The 1.5-day reduction in length of stay represents direct cost savings for hospitals, aligning with value-based care initiatives.

The Geisinger data on cardiac amyloidosis expands the potential use cases beyond standard heart failure patients, suggesting broader applicability of the technology across specialized cardiac conditions. This multi-indication validation strengthens the overall value proposition for hospital adoption.

The combination of FDA clearance, enhanced technology, and strong clinical outcomes data creates a compelling commercial inflection point for Daxor's technology adoption in the heart failure management space, where reducing readmissions remains a critical unmet need with significant financial implications for healthcare systems.

Three Studies Validate BVA-Guided Care Significantly Cuts Hospital Readmissions and Boosts Survival in High-Cost Heart Failure Segments

OAK RIDGE, TN, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces significant commercial momentum and clinical validation following the Heart Failure Society of America (HFSA) Annual Scientific Meeting. The company’s successful debut of its newly FDA-cleared, next-generation BVA analyzer signals a new era of data-driven fluid management for a multi-billion-dollar market.

The initial response from clinicians confirmed robust market demand for the new system, driven by its enhanced ease of use, speed, and over 95% accuracy.

New Clinical Data Validates Commercial Opportunity

During the meeting, new clinical data presented from three leading institutions further validated Daxor’s BVA technology across critical, high-cost patient populations:

• Banner University Medical Center (Heart Failure Care): New data confirms the urgent need for a focus on "volume re-calibration" in heart failure care. Patients with optimal total blood and red cell volume as measured by Daxor's BVA test had zero unplanned hospital admissions, versus 57-77% for those with imbalances in either total blood or red blood cell volume. These findings prove objective BVA measurement reveals patients needing additional treatment to prevent readmissions

• Wellstar Health System (Left-Ventricular Assist Device (LVAD) Implantation): The use of BVA-guided care pre- and post-LVAD implantation led to remarkable outcome improvements. The study showed substantially reduced severe acute kidney injury, one of the leading complications from LVAD procedures. Quantified results demonstrated this approach boosted 30-day survival from 90.3% to 93.6% and 1-year survival from 79.6% to 87.8%; cut 30-day readmissions from 28.6% to 18.5%; and decreased post-operative length of stay by 1.5 days

• Geisinger Medical Center (Cardiac Amyloidosis): New data confirms that patients with Cardiac Amyloidosis (CA) have significantly higher total blood and plasma volumes. BVA can help diagnose this unique CA phenotype, assisting clinicians with accurate diuretic dosing for better patient function

“The data presented at HFSA, particularly the clinical findings showing zero unplanned readmissions for optimally managed patients, provides undeniable evidence that BVA is an essential diagnostic for improving care and reducing costs,” said John L. Jefferies, MD, MPH, MBA, Chief Medical Officer of Daxor Corporation. “Coupling this overwhelming clinical validation with our faster, more accessible analyzer means Daxor is now ideally positioned to capture a significant commercial share of this multi-billion-dollar market.”

About Daxor Corporation

Daxor Corporation (NASDAQ: DXR) is tackling healthcare's "multi-billion-dollar silent crisis", the inability to precisely measure blood volume. This often results in suboptimal care, prolonged hospital stays, and increased readmissions for many high-cost medical conditions like heart failure and those requiring ICU care. With 50 years of experience and innovation, Daxor is proud to manufacture and distribute its patented, FDA-cleared Blood Volume Analysis (BVA) diagnostic which offers unmatched, real-time, precise data via its rapid, hand-held, lab-based system. This empowers clinicians to make individualized treatment decisions that significantly improve patient outcomes and deliver substantial efficiencies in value-based healthcare. Daxor is ISO certified and operates a U.S.-based, 20,000-square-foot state-of-the-art manufacturing facility, positioning the company for accelerated market expansion.

For more information, please visit our website at Daxor.com.

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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 risks 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
COO – Head of Capital Markets
COREIR
(561)-479-8566-Cell
brets@coreir.com|www.coreir.com

FAQ

What are the key features of Daxor's new FDA-cleared BVA analyzer?

The next-generation BVA analyzer features enhanced ease of use, faster processing, and over 95% accuracy in blood volume measurement.

How effective is Daxor's BVA technology in reducing hospital readmissions?

According to Banner University Medical Center data, patients with optimal blood volume showed zero unplanned hospital admissions, compared to 57-77% readmission rates for those with volume imbalances.

What improvements did Daxor's BVA-guided care show in LVAD patient outcomes?

BVA-guided care improved 30-day survival from 90.3% to 93.6%, 1-year survival from 79.6% to 87.8%, reduced 30-day readmissions from 28.6% to 18.5%, and decreased post-operative stay by 1.5 days.

How does Daxor's BVA technology help in Cardiac Amyloidosis treatment?

BVA helps diagnose the unique Cardiac Amyloidosis phenotype by identifying significantly higher total blood and plasma volumes, enabling clinicians to optimize diuretic dosing for better patient outcomes.

What is the market opportunity for Daxor's BVA technology?

Daxor is positioned to capture a significant share of a multi-billion-dollar market, supported by strong clinical validation and the new, more accessible analyzer.