Tiara Heart Valve_Transcatheter Mitral Valve Implantation (TMVI) Treatment for Mitral Regurgitation

Heart Valve Solutions

Focused on the development and manufacture of medical devices to treat heart valve and vascular disease, Neovasc has achieved outstanding success in business development, revenue growth, and strategic partnerships. As the cardiovascular industry’s premier supplier of crosslinked pericardium (bovine tissue and porcine tissue) for prosthetic heart valves and vascular surgery applications, Neovasc has a solid foundation upon which to develop their two pipeline projects. The Neovasc Reducer, a coronary sinus reduction device, developed for refractory angina treatment has done well in clinical trials in Europe and promises to be the first device to address refractory angina treatment successfully. The Neovasc Tiara is a prosthetic mitral valve being developed to treat mitral regurgitation. Using transcatheter mitral valve implantation (TMVI) methodology, this mitral heart valve is currently in animal trials with first-in-man planned for 2013.

Heart Valve Success

Neovasc is quickly becoming known as one of Canada’s best medical device success stories.  The company has executed a novel strategy of growing a cash generating tissue business while developing two world leading cardiovascular implants with multi-billion dollar market potential at the same time.  They have succeeded on all three fronts in this highly competitive and highly technical business space.  In 2011 the company was named to the TSX Venture 50 and in 2012 Neovasc announced that it had finalized its agreement with LeMaitre Vascular, allowing LeMaitre to exercise its option to purchase certain specific rights to Neovasc’s biological vascular surgical patch product technology on an accelerated basis, at an agreed price of US $4.6 million.

In November 2011 the company’s flagship Reducer product received the CE mark allowing Neovasc to begin marketing the device in Europe.  The Reducer has shown excellent clinical results for treating refractory (untreatable) angina with clinical trials throughout 2012 providing consistent, positive outcomes. It’s estimated that there are over one million patients in Europe currently who are candidates for the Reducer with 200,000-400,000 new patients every year.

Heart Valve Innovation

The company also significantly advanced its Tiara mitral valve replacement program with excellent animal implantation results and is now forecasting first human implantation in late 2013. This will be a significant medical milestone as there has never been a published case of a successful human implantation of a transcatheter prosthetic mitral valve. Tiara would be the first catheter implanted human prosthetic mitral valve and is arriving at a time when catheter implanted valves are expected to massively expand the valve industry.

Both the Tiara and the Reducer products are complex innovations which will significantly impact the competitive landscape in their respective clinical areas.