ThromboVision Completes T-Guide® Clinical Trials; Files with the FDA for Clearance to Market
HOUSTON, July 29, 2008 – Having completed clinical trials of its ThromboGuide® (T-Guide®) Platelet aggregation system, ThromboVision, Inc., a Houston-based biomedical diagnostics company, has filed a 510(k) application with the Food and Drug Administration for clearance to market the T-Guide.
Clinical trial data were gathered through independent studies at four research facilities: The Methodist Hospital Research Institute, Houston; University of Arizona, Tucson; Intermountain Medical Center, Salt Lake City; and Houston Institute for Clinical Research. The principal investigators at the sites were Drs. Neal Kleiman, Marvin Slepian, Jeffrey Anderson, and Dale Halter, respectively.
“With nearly 50 million patients on medications like aspirin and clopidogrel (Plavix®) to modify the aggregability of their platelets, we are anxious to be able to offer our technology to doctors who treat patients for heart attacks, strokes, and stents occlusion prevention,” said ThromboVision President & CEO Edward R. Teitel, MD, JD.
“Our 510(k) application is the culmination of research that began at the Utah Artificial Heart Institute, Brigham Young University, The University of Utah, and Thrombodyne, Inc. in 1998 and was supported by multiple NIH grants. After obtaining the worldwide, exclusive rights to the technology, ThromboVision did a great deal of design and engineering work to advance it to this point,” Teitel continued. “We are hopeful that when the FDA reviews our data and other materials, they will respond positively.”
A successful 510(k) application results in FDA clearance to market the device.
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 providing additional information as they assess an individual patient’s anti-platelet therapy used to prevent heart attacks, strokes and stent occlusions.
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
ThromboVision is a Houston Technology Center (HTC) client company. HTC is a business accelerator that assists Houston-based emerging technology companies in key sectors such as Energy, Information Technology, Life Sciences, Nanotechnology and NASA-originated technologies. www.houstontech.org
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.