CryoLife's Stake in ValveXchange

Medical devices and tissue processing company CryoLife (CRY - Snapshot Report) recently revealed an equity investment of $3.5 million in ValveXchange Inc., a privately held device company hived out of Cleveland Clinic.

ValveXchange develops life-long heart valve replacement know-how including exchangeable bioprosthetic leaflets. It is an emerging tech company, based in Colorado, developing the first “serviceable” bio-prosthetic heart valve. By raising the probability of time-to-time, less invasive exchange of old leaflet set, younger patients may avoid the utilization of a mechanical valve and its life-long Coumadin anti-coagulation therapy.

Per the deal terms, CryoLife will be given about 19% initial equity in ValveXchange along with certain other rights, such as the ability to negotiate with ValveXchange for distribution rights in Europe. In addition, CryoLife will provide as much as $2 million in extra debt funding using a revolving credit facility.    

A spokesperson for CryoLife stated that the novel replaceable bioprosthetic leaflet design of ValveXchange heart valves may have the capability to obviate repeat open heart surgeries (due to long-term wear problems associated with present-day biological valves).

For its part, a senior official of ValveXchange stated that animal studies reveal encouraging data set with valve leaflet and second exchanges proceeding without hitches. The funding will assist first-in-man procedures of its Vitality Exchangeable Heart Valve System, expected later during the year, followed by an anticipated European clinical trial.

The Vitality Exchangeable Heart Valve System brings together the longevity and safety of frequently utilized surgical bioprosthetic valves with the capability to provide less invasive access for transapical valve exchange. Vitality, a two-part valve platform for patients of different ages, may beat the challenges from prolonged leaflet wear and the need for repeated invasive valve replacement operations.

The second generation system from ValveXchange, the Vanguard, is expected to permit implantation and also valve exchange procedures to be performed transapically, via a minor cut between the ribs and a small hole at the apex of the heart, which heal rapidly.

CryoLife is an early mover in the process and distribution of implantable human tissues for usage in cardiac and vascular operations across Canada and the U.S. Among other products, the company’s CryoValve SG pulmonary heart valve, based on its proprietary SynerGraft know-how, received FDA 510(k) clearance for replacement of defective natural or prosthetic pulmonary valves.

CryoLife possesses 10 patents covering heart valve and associated know-how with 10 more patent applications under process. The company competes, in certain niches, with St. Jude Medical (STJ - Analyst Report) and Edwards Lifesciences Corp. (EW - Analyst Report).

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