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Colibri Heart Valve Announces Issuance of Patent for New Method of Making Replacement Heart Valves

Thursday, February 02, 2012

Broomfield, CO -- Colibri Heart Valve, LLC, a privately held medical device company, received an Issue Notification from the U.S. Patent and Trademark Office regarding the forthcoming granting of its U.S. Patent No. 8,109,995 titled, "Percutaneously Implantable Replacement Heart Valve Device And Method Of Making Same." The patent will issue on February 7, 2012 and is directed to a method of making a percutaneously implantable replacement transcatheter aortic heart valve using a folding technique covering both bovine and porcine pericardium. The associated patent application (12/228,192) has priority claims with content dating back to January 4, 2002. It is expected that the patent will provide Colibri with broad protection to prevent others from producing or distributing valves based on this folding technique through January 4, 2022.

"We believe that replacement heart valves that use the unique folded tissue design will have meaningful benefits over currently available valves, including a reduced profile and increased resistance to wear," said Joseph B. Horn, Colibri's president and chief executive officer. "With this IP in place, and with additional patents pending directed to a pre-packaged, sterilized, percutaneous heart valve delivered through a 14 French sheath, we believe Colibri is well positioned to initiate first-in-human clinical trials with the Colibri valve later this year."

Colibri recently completed a $5M Series B financing by a consortium of angel and high-net-worth private investors. This capital will be used to commence a first-in-human clinical trial of the Colibri valve replacement system in patients with a symptomatic stenotic aortic valve who are candidates for Transcatheter Aortic Heart Valve Implantation (TAVI). This study will seek to enroll 5-10 patients in pre-identified centers in Western Europe.

About the Colibri Valve Replacement System for TAVI

TAVI has become an important treatment option in the U.S. for heart valve replacement due to its minimally invasive nature, clinical efficacy, extensive patient experience as an approved procedure in the U.S. and Europe, and reduced procedural costs. Colibri's heart valve device incorporates advantages not available in any other valve either currently available or in known development. These advantages are realized through unique features including a significant profile reduction compared to other currently available devices, a folded valve construct using minimal sutures, thin and durable low-profile tissue leaflets, a dry valve which is pre-mounted at manufacture and pre-packaged with the valve fully integrated on its delivery system. The proprietary double balloon technology allows stabilized valve deployment and adjustment capabilities for accurate valve placement. Colibri's proprietary tissue preparation process makes the Colibri replacement heart valve highly biocompatible and resistant to calcification.

About Colibri Heart Valve, LLC

Colibri Heart Valve, LLC is a privately held medical device company committed to the research and development of novel heart valve technologies, including the Company's dry, pre-mounted, low profile, "package-to-patient" percutaneous transcatheter heart valve (THV). The unique features of this valve replacement system include its delivery technology and durable valve tissue, potentially providing major benefit by decreasing procedural vascular complications and improving overall TAVI outcomes. Colibri Heart Valve was founded by R. David Fish, MD, and David Paniagua, MD, pioneering interventional cardiologists. Colibri's corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado with R&D located in Houston, Texas. For more information, visit:

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