Company Overview

Dedicated to bringing one product to market
Endovalve was founded in 2005 to develop and commercialize the Endovalve mitral valve replacement system for treating mitral regurgitation (MR). The system is designed for insertion during a minimally invasive surgical procedure, allowing a complete valve replacement without the risks and complications associated with both sternotomy and cardiopulmonary bypass.

While some 40,000 patients have either valve repair or valve replacement surgery each year, the majority of an estimated four million MR sufferers in the United States let the disease go untreated in part because of the fear and risks associated with cardiopulmonary bypass. While there are a variety of new mitral valve repair techniques being developed, Endovalve is focused on developing a replacement system that can be delivered via minimally invasive surgery, with the potential for simpler insertion and markedly greater reduction or elimination of mitral regurgitation when compared with minimally invasive repair techniques. We believe that this type of replacement system and procedure could offer a more cost-effective and safer alternative to current treatments, and a vastly superior alternative to doing nothing, especially in patients who today do not get offered surgery because of pre-existing illness.

Strategically supported by venture partner
Since it was funded by Battelle Ventures and its affiliate, Innovation Valley Partners, Endovalve has been functioning as a highly capital-efficient virtual company, using Battelle Ventures’ offices in Princeton, N.J., as its operational headquarters and outsourcing R&D. Besides being a committed investor, Battelle Ventures has provided operational support, first installing “entrepreneur in residence” Dr. Robert Wilkins as Endovalve CEO and president and then bringing Todd Tomba from Battelle Memorial Institute to the team, as vice president of R&D. The company continues to draw on the funds’ management and infrastructure resources.

Reaching milestones
Working in concert with established R&D outsourcing partners, Endovalve has successfully completed development of a functional proof-of-concept prototype. Surgically implanted valve prototypes have repeatedly successfully supported live animals in short-term evaluations without significant hemodynamic disturbance. A prototype delivery system has been developed. Final design work, optimizing the proven initial design, is well advanced, and is planned to lead to a phase I clinical trial (“first in man,” or FIM, study) in late 2010, with chronic animal and human implants scheduled for 2011. After FDA approval of this system (expected by 2016), a percutaneous follow-on product is planned, leveraging the same valve design but with a necessarily more complex delivery system. (While a percutaneous product was the original mission of Endovalve and remains a key goal, physician feedback made it clear that there is a market need for a minimally invasive surgical approach.)

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