ValveXchange

ValveXchange, Inc. was a medical device company focused on developing a novel two-part bioprosthetic heart valve system. Founded in 2005 by Dr. Ivan Vesely, a noted heart valve scientist with research roots at the Cleveland Clinic, the company aimed to address the limitations of existing tissue and mechanical valves. Dr. Vesely, a biophysicist, dedicated his work to creating healthier heart valve solutions. The management team also included Larry Blankenship, a seasoned executive with a 40-year career in the medical device industry, having held leadership roles at multiple startups and divisions of major corporations like Pfizer and Eli Lilly.

The company's core product, the Vitality Heart Valve System, featured a patented two-part design. This system consisted of a permanent docking station surgically implanted in the heart and a separate, replaceable set of tissue leaflets. The primary benefit of this configuration was to allow for future replacements of the leaflets—the part of the valve that wears out over time—through a minimally invasive procedure, potentially avoiding repeat open-heart surgeries. This was particularly aimed at younger patients who often face the choice between a durable mechanical valve requiring lifelong anticoagulation therapy or a tissue valve that will likely need a high-risk replacement surgery in 10-15 years. The system, which included the VXi Vitality for surgical implantation and the VXi Vanguard for transapical procedures, was designed to make valve exchange simpler and safer.

ValveXchange's business model revolved around the development, clinical testing, and eventual commercialization of its proprietary heart valve systems. The company secured approximately $4.03 million in funding over four rounds, with its final Series A round in September 2011 led by CryoLife, a medical device company that became a key strategic investor. A significant milestone was achieved in September 2011 with the first successful human implants of the Vitality system in three patients in Paraguay. In 2009, the company's technology was recognized with the Frost & Sullivan North American Technology Innovation of the Year Award. Despite these achievements and proceeding to European clinical trials, ValveXchange's products were not approved by the U.S. FDA, and the company is now listed as inactive or 'deadpooled'.

Keywords: bioprosthetic heart valve, cardiac surgery, medical device, valve replacement, exchangeable leaflets, transcatheter valve, minimally invasive, CryoLife, cardiovascular health, tissue valve