Full Press Release Details
NEW YORK, NY--(Marketwire - July 28, 2009) - Daxor Corporation (NYSE Amex: DXR), a medical
instrumentation and biotechnology company, today announced the undertaking
of the TEAM-HF multi-center heart failure treatment clinical study.
The Treatment to Euvolemia (normal blood volume) by Assessment and Measured
Blood Volume in Heart Failure or "TEAM-HF" study protocol is a
multi-center prospective randomized trial to compare heart failure
management strategies based on the current standard of clinical assessment
of a patient's blood volume status versus the direct blood volume
measurement through the use of Daxor's Blood Volume Analyzer BVA-100. The
objectives of TEAM-HF are to determine the decrease of re-hospitalizations,
all cause mortalities, cardiovascular mortalities and any improvement in
the exercise capacity and quality of life in patients being treated for
heart failure when a blood volume analysis is incorporated in their
standard diagnosis and treatment. Leading heart failure diagnostic and
treatment centers in New York, NY, Pittsburgh, PA, Winston-Salem, NC and
Honolulu, HI have already confirmed their participation.
The current Heart Failure Society of America, American College of
Cardiology and American Heart Association treatment goals and practice
guideline recommendations emphasize that it is critical to evaluate and
treat a patient's blood volume to a normal status. Current practices rely
solely on various signs and symptoms, along with various surrogate
laboratory tests, to determine a patient's blood volume. These surrogate
measures are often inaccurate. Daxor's BVA-100 is the only FDA approved
instrument which accurately measures a patient's volume status. Recent
published studies from Columbia Presbyterian Medical Center have
demonstrated that the assessment of a patient's blood volume status is only
correct 51% of the time compared to a measured blood volume analysis. The
Heart Failure Society of America states that "clinical experience suggests
it is difficult to determine that congestion has been adequately treated in
About 5 million people in the United States have been diagnosed with heart
failure and over 300,000 die from it every year. The total estimated
direct and indirect cost for treatment of heart failure is approximately
$28 billion. In 2005, approximately 37% of all Medicare spending and 50%
of inpatient hospital costs were attributed to Medicare beneficiaries being
treated for heart failure. Heart failure is a life-threatening condition
where the heart muscle cannot pump enough blood to the rest of the body.
The most common causes of heart failure are hypertension and coronary heart
"It is our hope that this 300 patient study involving at least 9 medical
centers will demonstrate the clinical utility of a blood volume analysis in
the treatment of heart failure patients," noted Daxor's Chief Scientific
Officer and CEO, Dr. Joseph Feldschuh. Dr. Feldschuh noted that "Previous
studies have shown that heart failure patients who have been treated to a
normal blood volume, as determined by the BVA-100, had a 100% survival rate
over a two year period versus patients who remained volume overloaded who
had a 55% death rate. These early published findings are extremely
significant, especially since hospitals are now losing their reimbursement
for repeated hospitalizations within a 30-day period for the treatment of
Unpublished studies from two heart failure centers have shown that some
heart failure patients cannot be treated by medications alone, but also
require adjunct therapies such as phlebotomy, the removal of excess blood.
Therapeutic phlebotomy was once a mainstay for the treatment of heart
failure, but is currently only used in limited instances. A Blood Volume
Analysis (BVA) can identify which patients may be compromised by
inappropriate medical treatments and which would benefit from the removal
of excess blood. Without a BVA it is extremely difficult to identify
patients who may be anemic and would be harmed from the removal of blood by
phlebotomy. The current administration's efforts to improve the efficiency
of medical treatments are consistent with the main goals of the
TEAM-HF study. If it can be determined that a BVA leads to more
appropriate treatments and better outcomes, the BVA-100 may become a
standard of care in heart failure.
TEAM-HF study is anticipated to begin sometime within the third quarter of
2009 and will complete its enrollment and study of patients within 12
Daxor Corporation manufactures and markets the BVA-100, a semi-automated
Blood Volume Analyzer. The BVA-100 is used in conjunction with Volumex,
Daxor's single use diagnostic kit. For more information regarding Daxor
Corporation's Blood Volume Analyzer BVA-100, visit Daxor's website
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