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Neovasc Inc (2)
Symbol NVCN
Shares Issued 28,017,203
Close 2019-02-21 C$ 0.84
Market Cap C$ 23,534,451
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Neovasc cheers five-year anniversary of Tiara patient

2019-02-21 09:35 ET - News Release

Mr. Fred Colen reports

NEOVASC CELEBRATES 5-YEAR ANNIVERSARY OF TIARA PATIENT AS THE LONGEST SURVIVING TRANSCATHETER MITRAL VALVE REPLACEMENT IN THE WORLD

Neovasc Inc. has noted that a patient implanted with a Tiara transcatheter mitral valve replacement device has celebrated her fifth anniversary since undergoing the procedure. The company believes that this patient is the longest-surviving transcatheter mitral valve replacement therapy recipient in the world.

Dr. Anson Cheung stated: "This patient had a long history of ischemic cardiomyopathy with multiple heart failure hospitalizations. She was referred to our heart failure program at St. Paul's Hospital for heart transplant evaluation. Discussion with our heart team included the choice of either going onto the heart transplant list or receiving a very new technology, the Tiara. We discussed the potential risks and benefits with her as she would be only the second patient in the world to receive this device. She made the decision to move forward and successfully received the Tiara. As a result of receiving the Tiara device, the patient is alive and well, without mitral regurgitation (MR), has not required heart failure hospitalization and is clinically too well for heart transplantation. At a recent follow-up, the patient showed a fully functional valve with a gradient of three mmHg [millimetres of mercury] and remains in NYHA I-II."

The patient stated: "I wish to express my sincere thanks to everyone that is helping bring the Tiara to patients. I am so grateful for this technology and the hospital for giving me my life back."

Fred Colen, Neovasc's president and chief executive officer, stated: "We are pleased that this patient has had such a positive outcome after receiving a Tiara device five years ago as it speaks directly to the long-term benefits that this technology offers MR patients. We look forward to continuing to treat additional patients and gain additional clinical experience in our Tiara clinical studies."

At the time of the procedure, which was performed by Dr. Anson Cheung, professor of surgery and director of cardiac transplant of British Columbia at St. Paul's Hospital in Vancouver, Canada, the female patient was 60 years old and a high-risk candidate for surgery with severe MR. The Tiara valve was used to replace the patient's diseased native mitral valve. Upon implantation, the patient experienced immediate elimination of the MR without paravalvular leak as well as an immediate increase in stroke volume and decrease in pulmonary pressure. At her two-month follow-up, the patient demonstrated a marked improvement in symptoms compared with baseline, with an NYHA functional Class II (mild) compared with an NYHA Class IV (severe) prior to the Tiara implantation. The New York Heart Association (NYHA) functional classification is a standard method used for classifying the extent of heart failure symptoms and places patients in one of four categories based on their limitations in physical activity. As of the five-year anniversary of undergoing the Tiara implantation, this patient continues to report excellent prosthetic valve function and is currently an NYHA Class I/II with significant improvement in quality of life.

About Tiara

Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the United States, with a similar number of patients affected throughout Europe. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach without the need for open-heart surgery or use of a cardiac bypass machine.

The Tiara valve is currently being evaluated in two continuing clinical trials: Tiara-I (an early feasibility trial in the United States, Canada and Belgium) and Tiara-II (a European Conformite Europeenne Mark trial in Germany, Italy and the United Kingdom). In addition, patients have also been treated under compassionate programs in Canada, Italy, Germany, Israel and Switzerland.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Reducer for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and the Tiara for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe.

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