Healthcare Industry News: ultrasound imaging
News Release - January 9, 2006
POINT Biomedical Submits New Drug Application (NDA) for CARDIOsphere(R) for the Assessment of Coronary Artery DiseaseSAN CARLOS, Calif.--(HSMN NewsFeed)--Jan. 9, 2006--POINT Biomedical Corp. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market CARDIOsphere (PB127) for the detection and localization of obstructive coronary artery disease. CARDIOsphere is a myocardial perfusion agent used with ultrasound imaging.
"The submission of this NDA is an important milestone for POINT," said POINT CEO Dr. Jerry Griffin. "This is the first NDA submission for a myocardial perfusion imaging agent used with ultrasound. This NDA submission not only represents the dedicated efforts of our team but also that of an outstanding group of clinical investigators who were involved in the clinical development of CARDIOsphere. We are now looking forward to working with the FDA to ultimately be able to bring this procedure to patients as a non-invasive, non-radioactive means of assessing coronary artery disease."
The NDA submission is based on the results of 11 clinical trials, involving more than 1300 patients and subjects including two multi-center Phase 3 clinical trials conducted in the United States. The Phase 3 trials were designed to evaluate the performance of CARDIOsphere for the assessment of myocardial perfusion using ultrasound imaging compared to radionuclide imaging, the current standard of care. If approved, CARDIOsphere will allow cardiologists to diagnose coronary artery disease in the office or hospital using standard ultrasound equipment and without the need for radioactive isotopes.
More than 13 million Americans suffer from coronary artery disease and an even larger number of individuals have risk factors or symptoms that make them potential candidates for coronary artery disease assessment by non-invasive means. Over 10 million non-invasive imaging procedures were performed to diagnose coronary artery disease in the U.S. last year.
About POINT Biomedical Corp.:
POINT Biomedical Corp., based in San Carlos, CA is an emerging pharmaceutical company. The Company discovers and develops novel products for diagnostic, molecular imaging and drug delivery applications based on its patented biSphere technology. For additional information, please visit the POINT Biomedical website at www.pointbiomedical.com.
The matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory approvals, results of product development programs, and clinical efficacy of and market demand for products, among other matters, may differ significantly from the discussion of such matters in the forward-looking statements.
CONTACT INFORMATION: POINT Biomedical Corporation, 887L Industrial Road, San Carlos, CA 94070, 650-596-1400 phone; 650-596-1402 fax.
Source: POINT Biomedical
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