Daxor receives FDA clearance for next-gen blood volume analyzer

NEW YORK - Daxor Corporation (NASDAQ:DXR), a $49.6 million market cap medical technology company trading near its 52-week high of $10.49, announced Thursday that it has received FDA 510(k) clearance for its next-generation blood volume analyzer (BVA), a compact, hand-held device designed for laboratory use. According to InvestingPro data, the company’s stock has shown remarkable strength with a 34% gain over the past six months.

The newly cleared device measures a patient’s blood volume against patient-specific norms to enable precise fluid management across various clinical conditions. According to the company, the analyzer is three times faster than its predecessor, weighs just 7 pounds, and maintains laboratory-grade diagnostic precision. With a solid financial health score rated as "GOOD" by InvestingPro, Daxor appears well-positioned to support the commercialization of this new technology.

"This critical knowledge gap has impacted treatment decisions across numerous medical specialties," said Michael Feldschuh, Daxor’s President and CEO, referring to the limitations of traditional methods for estimating blood volume status.

The technology uses tracer dilution technique to measure blood volume, which the company describes as the gold standard for accuracy. The device is intended for use in multiple medical fields including cardiology, nephrology, critical care, and emergency medicine.

Daxor cited peer-reviewed studies showing that blood volume analysis guided care was associated with reduced heart failure one-year mortality by 86% and demonstrated shorter hospital stays and 56% fewer readmissions. A separate randomized control trial in ICU patients reportedly showed 66% lower mortality in a cohort of predominantly septic/ARDS patients.

The analyzer was developed under contract with the U.S. Department of Defense, specifically the U.S. Army and the Defense Health Agency.

Daxor’s blood volume measurement technology aims to address fluid management challenges in conditions such as heart failure, critical care, sepsis, dialysis, and traumatic injury.

Based on a company press release, the device builds upon Daxor’s previous BVA-100 analyzer and is designed to enable broader clinical adoption in resource-limited settings. While the company maintains a high P/E ratio of 90.25 and analysts anticipate some near-term sales challenges, detailed analysis and additional insights are available through InvestingPro’s comprehensive research reports, which provide in-depth coverage of over 1,400 US stocks.

In other recent news, Daxor Corporation received FDA 510(k) clearance for its next-generation blood volume analysis system. This device, known as the Daxor BVA™, is a compact, hand-held tool designed to improve fluid management in clinical settings. The system is notable for processing results three times faster than its predecessor while maintaining laboratory-grade diagnostic precision. This advancement is expected to provide critical data for precise fluid management across various medical conditions. Additionally, Daxor held its annual meeting of shareholders, where six directors were elected to serve until the next annual meeting. The elected directors include Henry D. Cremisi, MD; Edward Feuer; Joy Goudie, Esq.; Michael Feldschuh; Jonathan Feldschuh; and Caleb DesRosiers, Esq. The shareholders also ratified the company’s auditor during this meeting.

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