OPKO Health, a multinational biopharmaceutical and diagnostics company, announced that its investee, Neovasc has received conditional Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (US FDA) to initiate the US arm of its TIARA-I Early Feasibility Trial for the company's Tiara transcatheter mitral valve.

The TIARA-I Early Feasibility Trial is a multinational, multicentre trial being conducted to assess the safety and performance of Neovasc's Tiara mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation (MR).

Severe MR is a critical condition that affects millions of patients and, if left untreated, can lead to heart failure or death. This FDA conditional approval allows clinical investigators to begin enrolling patients at participating US medical centres once local hospital and related approvals are in place.

"This is a significant affirmation of Neovasc's Tiara device as we believe that Neovasc is the first company to start a feasibility trial with a transcatheter mitral valve in the US," stated Phillip Frost, M.D., Chairman and chief executive officer of OPKO. "FDA's conditional approval and the commencement of the feasibility trial in the US is an important step towards Tiara becoming one of the first transcatheter mitral valve replacement devices available for treating US patients."

The TIARA-I Early Feasibility Trial will enroll up to 30 patients globally and is being overseen by a multidisciplinary committee of internationally recognized physicians co-chaired by Dr. Martin Leon (Director, Center for Interventional Vascular Therapy Columbia University Medical Center / New York-Presbyterian Hospital) and Dr. Anson Cheung (Professor of Surgery and Director of Cardiac Transplant at St. Paul's Hospital, Vancouver Canada). With this FDA approval, TIARA-I is expected to enroll patients at three highly respected US medical centres: Columbia University Medical Center / New York-Presbyterian Hospital (New York), Lenox Hill Hospital (New York) and Cedars-Sinai Medical Center (Los Angeles). The Company is now focusing on training participating clinical teams and obtaining institutional approvals with the goal of enrolling the first US patients by early 2015.

TIARA-I also has received ethics committee approval at Antwerp Cardiovascular Center / ZNA Middelheim in Belgium and competent authority notification is pending. First European enrollment is expected before the end of the year. Applications are underway for additional centers in Europe and Canada.

Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Significant MR can lead to heart failure and death. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the US alone. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach and is designed to replace the diseased native mitral valve without the need for open-heart surgery or use of a cardiac bypass machine.

The first human implantations of Tiara were completed successfully earlier this year under Canadian Special Access, by the medical team at St. Paul's Hospital in Vancouver, Canada. Early clinical results of Tiara implantations have been promising, resulting in fully functional valves, with complete resolution of mitral regurgitation, and no valve leakage. There have been no device related complications observed to date in patients treated with Tiara.