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 company's 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".
BSP - Biological Signal Processing Ltd