New Randomized Controlled Trial Demonstrates the Efficacy of Daxor’s BVA Guided-Care in Heart Failure Patients
November 13 2023 - 8:00AM
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 ShapiroSr.
Managing Partner, CORE IR1-516-222-2560brets@coreir.com
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