Cleveland Clinic's heart valve start-up nets $3.5M

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CryoLife, a tissue processing and medical device company focused on cardiac and vascular surgery, has gained a $3.5 million equity investment in ValveXchange, a private medical device company that was spun-off out of Cleveland Clinic to develop a heart valve replacement technology platform with exchangeable bioprosthetic leaflets.

Under the agreement, the Atlanta-based CryoLife will receive an approximate 19 percent initial equity ownership in ValveXchange, in addition to the right of first refusal to acquire ValveXchange during a period that extends through the completion of initial commercialization milestones, as well as the right to negotiate with ValveXchange for European distribution rights. Further, CryoLife will make available up to $2 million to ValveXchange in additional debt financing through a revolving credit facility.

Larry Blankenship, chair and CEO of ValveXchange, said, "This funding will support first-in-man procedures of our Vitality exchangeable heart valve system, anticipated to occur later this year, followed by a planned European clinical trial."

The Vitality exchangeable heart valve system uses surgical bioprosthetic valves that provide minimally invasive access for transapical valve exchange. Vitality is a two-part valve platform for patients that can potentially overcome the challenges of long-term leaflet wear and the requirement for repeat invasive valve replacement surgery. ValveXchange said its second generation system, the Vanguard, is designed to allow both the implantation and valve exchange procedures to be done transapically, through a small incision between the ribs and a small hole in the apex of the heart. With ValveXchange technology, off-pump MIS techniques can be applied to both the initial implant and subsequent exchanges later in life.