Neovasc’s Refractory Angina Treatment Receives CE Mark

Neovasc Inc. (TSXV: NVC) is a publicly traded specialty medical device company that develops, manufactures and markets its products for the treatment of cardiovascular disease. The company just announced that it has received the CE mark approval for its Reducer product, which was developed to treat refractory angina. The CE reveals that the product can be marketed for implantation in patients in the European Union, the European Economic Area and Switzerland.

The Neovasc Reducer is a treatment delivered through the skin designed to treat the millions of people suffering from refractory angina. The disease results from inadequate blood flow to the heart muscle that cannot be managed through conventional drug, catheter or surgical therapy. While the global incidence of the disease continues to grow, an estimated one million people suffer from it in the EU. The disease causes constant and severe heart pain and significant disability that negatively impacts the quality of life for millions of patients.

The Reducer procedure is similar to a coronary stent implantation and takes approximately 20 minutes using standard catheter-based techniques. The Reducer is implanted in the coronary sinus vein using minimally invasive techniques. By modulating blood flow from the main vein exiting the heart, the Reducer acts to increase the supply of oxygenated blood to certain areas of the heart muscle, as a result, reducing the pain and disability caused by the condition.

“The Reducer’s CE mark designation is good news for European refractory angina patients, who previously had exhausted available treatment options but who will now have access to this novel treatment for relieving their symptoms and improving their quality of life,” said Dr. Shmuel Banai, Medical Director of Neovasc. “In addition, the Reducer is implanted using a procedure that is minimally invasive and requires less than 20 minutes to complete.”

After a 3-year clinical study, it has been demonstrated that the Reducer safely and effectively provides relief of angina symptoms in refractory angina patients. Neovasc is in the process of enrolling patients in the Coronary Sinus Reducer for Treatment of Refractory Angina trial (COSIRA). COSIRA is a trial intended to further demonstrate the safety and effectiveness of the procedure, and to support physician education and marketing efforts.

“We are very pleased to have received CE mark designation to treat this critical patient population with high unmet need,” noted Alexei Marko, CEO of Neovasc. “In the immediate term we will continue to focus on completing enrollment in the COSIRA trial in order to obtain additional data that we expect will be very valuable in supporting medical education and marketing activities for the Reducer. We are currently evaluating a number of options for European commercialization and look forward to distributing the Reducer in select European markets beginning in 2012.”

Neovasc will be presenting its products and technologies at OneMedForum SF 2012, on January 9 – 12.

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