Healthcare Industry News: Artificial Heart
News Release - January 9, 2008
ThromboVision's T-Guide(R) Clinical Trials Under WayCompany partners with four key research institutes to garner patient data
ThromboVision, Inc., a Houston-based biomedical diagnostics company, has initiated clinical trials of its ThromboGuide® (T-Guide®) Platelet Function Monitor. Enrollment and data collection are under way at four key research institutes.
The facilities and principal investigators are:
- The Methodist Hospital Research Institute, Houston – Neil S. Kleiman, MD, medical director, Cardiac Catheterization Laboratories, The Methodist DeBakey Heart Center, The Methodist Hospital and The Methodist Hospital Research Institute; professor of medicine, Weill Medical College, Cornell University
- University of Arizona, Tucson – Marvin J. Slepian, MD, clinical professor of medicine; director of interventional cardiology, The University of Arizona College of Medicine
- LDS Hospital (Intermountain Healthcare), Salt Lake City – Jeffery L. Anderson, MD, associate chief of cardiology, LDS Hospital; co-director of cardiac research and professor of internal medicine, University of Utah; chair, ThromboVision scientific advisory board
- Houston Institute for Clinical Research, Dale Halter, MD, co-director.
“These clinical studies will build on knowledge obtained through studies completed as part of our early NIH grants and will provide the foundation of our 510(k) application to the FDA, expected in early 2008,” he continued. “We will follow with an additional study leading to a CLIA waiver application.”
A successful 510K application results in FDA clearance to market the device. A CLIA waiver enables nontechnical staff to run the tests in settings such as physicians' offices and clinics.
The T-Guide® consists of a disposable test kit and a point-of-care base unit. The system will help physicians improve their cardiac patients’ lives by individualizing antiplatelet therapy that they use to prevent heart attacks, strokes and stent occlusions.
ThromboVision has licensed the patented technology developed by scientists affiliated with the Utah Artificial Heart Institute, Brigham Young University and the University of Utah.
ThromboVision, Inc. is a biomedical company committed to enabling people to lead longer and healthier lives. ThromboVision provides easy-to-use, rapid-response, cost-effective, and versatile point-of-care clinical diagnostic discoveries that advance medical diagnosis. The company’s products will improve medical care by assisting physicians in diagnosing and managing critical cardiovascular risk factors, especially those related to platelet function and antiplatelet drug therapy. www.thrombovision.com
SAFE HARBOR STATEMENT
This release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Statements in this release regarding ThromboVision’s business that are not historical facts are “forward-looking statements,” which involve risks and uncertainties that could cause actual results to differ materially from any future results, performance, or achievements expressed or implied by such statements.
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