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Redwood City, CA -- November 21, 2005
Genesis Medical Interventional, Inc. (Genesis) today announced that the Polish Government has granted full approval to begin the F.A.S.T. coronary clinical study. The trial is a prospective, multi-center study designed to demonstrate safety and effectiveness of F.A.S.T.™ Proximal Occlusion System for embolic protection in Percutaneous Coronary Interventions (PCI's) as an adjunct to coronary stenting. Embolic liberation can be a serious complication of arterial stenting procedures that occurs during three phases of the intervention: (1) Crossing the lesion with a guidewire, balloon or filter; (2) During the balloon dilatation or stenting; and (3) Upon removal of the interventional tools.
"This approval in Poland is a nod to the efforts the entire Genesis team is making. The fact that the Polish Government as well as the individual ethics groups in Krakow sanctions our efforts is further proof that what we are doing is important. This study will continue progress toward limiting embolic 'showering' during PCI's and hopefully lead to improvement in patient safety. With the addition of Dr. Dariusz Dudek and his team in Krakow, we will indeed help determine the importance of our Proximal Occlusion Embolic Protection endeavors," said William Dubrul, CEO, of Genesis.
"The approval to begin this study of F.A.S.T.™ represents a major milestone for the company and we are excited to begin the trial immediately in Krakow with Dr. Dudek and his team." Dubrul continues.
About Genesis Medical Interventional, Inc.
Genesis Medical Interventional, Inc. (Genesis) is a privately held company developing products, based on its minimally invasive Funnel Catheter™ platform technologies, to remove thrombi and emboli from the vasculature. The company believes its technologies will have applications in many major medical markets.
The Genesis F.A.S.T.™ Funnel Catheter™ system is a simple funnel catheter that occludes blood flow and stops blood pressure prior to entering the interventional site. Before entering the lesion with even a small guide wire, the Genesis F.A.S.T.™ Funnel Catheter™ system temporarily occludes proximally with the funnel catheter . By temporarily stopping blood flow, emboli that are loosened cannot travel downstream because there is no downstream. The funnel gently deploys against the inner wall of the vessel using the patient's own blood pressure to create the occlusion in the vessel. The device also allows the physician to use the funnel to remove emboli and thrombi from the treated vessel by using simple aspiration from a syringe.
For additional information, please contact William R. Dubrul, Genesis CEO at will@genesismedical.net or visit the Genesis website at www.genesismedical.net
This press release contains forward-looking statements that are based upon management's current expectations and are inherently uncertain. Forward-looking statements are based upon information available to us as of the date of this press release and we assume no obligation to revise or update any such forward-looking statement to reflect any event or circumstance after the date of this release. Actual results and timing of events could differ materially from current expectations and from any forward-looking statements made by the company.
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