Tel – Aviv, November 14, 2011 – BSP
Biological Signal Processing Ltd. (BSP) (TASE: BSP), which develops and
manufactures products for the non-invasive, accurate diagnosis of Coronary
Artery Disease (CAD), recently announced the successful completion of a
comprehensive clinical research study evaluating the performance of the
companys HyperQ technology in diagnosing CAD. An article describing the study
and its results was accepted for publication in the prestigious American
Journal of Cardiology.
The study recruited 996 patients and compared the clinical
performance of HyperQ vs. conventional ECG for the detection of Coronary Artery
Disease (CAD), using nuclear imaging as the gold standard. The study was
conducted in two major medical centers in Israel
– Assuta Medical
Center and Sheba Medical
Center, and was headed by
Dr. Tali Sharir and Prof. Pierre Chouraqui. The major finding reported by the
researchers is a 30% improvement in the sensitivity of the HyperQ analysis in
the detection of CAD when compared to conventional stress ECG. HyperQ analysis
also had a lower false alarm rate compared to conventional stress ECG.
“This comprehensive study significantly deepens
clinical knowledge accumulated so far by our company and substantiates the
evidence that HyperQ improves the ability to diagnose ischemic heart disease,”
says Nissim Greisas, CEO of BSP. He added, “We believe that the results of
this study will have a major impact on the decision of cardiologists to
clinically implement the use of HyperQ products in their routine workup for
diagnosing and assessing ischemic heart disease.”
The results of this study were also recently presented,
together with additional HyperQ related clinical evidence, at a meeting and
hearing of the Medicare Evidence Development & Coverage Advisory Committee
(MEDCAC) in the US.
The MEDCAC meeting on November 9th was convened in order to consider and make
recommendations on the use of new ECG signal analysis technologies to detect CAD,
and regarding their inclusion in the coverage policies. MEDCAC is an advisory
committee, commissioned by to CMS (Centers for Medicare & Medicaid
Services) – the organization responsible for the determination of the services
and medical products that will be reimbursed by Medicare and Medicaid, also
heavily weighing in on the coverage policies of private insurers in the US. The
MEDCAC committee concluded its discussions with a recommendation encouraging
the CMS to include new signal analysis technologies, that are FDA cleared and
have shown sufficient clinical evidence, in the coverage policies for cardiac
care and diagnosis.
“Appearing before MEDCAC committee is an important
milestone in the process of obtaining reimbursement for our products in the U.S.,”
says Dr. Amir Beker, Chairman of BSP, who presented at the hearing. He added,
“This endeavor is also backed by a HyperQ large-scale clinical study in
three leading US medical
centers, The Cleveland Clinic, University
of Virginia medical center and
Minneapolis Heart Institute Foundation, to collect clinical and economic data
in support of BSP’s reimbursement campaign in the US”.
About Biological Signal Processing Ltd.
Founded in 2000, BSP develops the most accurate stress ECG equipment for
diagnosing Coronary Artery Disease (CAD) for men and women. HyperQ, BSPs
proprietary signal processing technology, focuses on a brand new component of
the ECG signal, significantly improving the accuracy of the stress ECG test and
making HyperQ technology- the new standard for the early detection of coronary
artery disease. BSP is a public company, traded on the Tel Aviv Stock Exchange
since 2006 (TASE:BSP). The companys headquarters are located in Tel Aviv, Israel with offices in Boston, US.