Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. In conjunction with its formation, Colibri has granted Colorado Therapeutics a license to develop and market innovative and disruptive xenogenic (sourced from different mammalian species) biologic tissue matrix products for a broad range of soft tissue reinforcement, regenerative, and vascular applications outside of structural heart. Colorado Therapeutics will initially target the soft tissue repair and reinforcement markets, and recently announced the filing of a 510(k) to commercialize a tissue matrix product for this application including the repair of hernia defects.

“The formation of Colorado Therapeutics allows Colibri to monetize the Company’s proprietary technology in applications outside of the heart, and focus on the development of structural heart products such as the Colibri TAVI System, which is preparing to enter a CE Mark clinical program,” commented Joseph B. Horn, Colibri’s president and chief executive officer.

The Colibri TAVI System has been successfully tested in a first-in-human study in patients with severe symptomatic aortic valve stenosis who are deemed very high risk for open-heart valve replacement surgery. Study participants have been followed for more than three years and have demonstrated consistent positive outcomes, including no observed stroke, no pacemaker implantations, virtually no paravalvular leak (PVL), and a high retained average effective orifice area (EOA) >2.2cm2. To support the planned CE Mark clinical program, Colibri announces the conversion of all outstanding Sr. Secured Notes and the opening of a Series C financing.

Mr. Horn continued, “With the formation of Colorado Therapeutics and the conversion of the Sr. Secured Notes, Colibri is well positioned to move forward in a debt free position to continue pre-clinical and clinical development of the Colibri TAVI balloon and self-expanding systems.”