Mr. Alexei Marko reports

NEOVASC PROVIDES UPDATE ON ITS TIARA(TM) MITRAL VALVE CLINICAL PROGRAM

Neovasc Inc. has provided an update on the clinical experience with its Tiara transcatheter mitral valve. Tiara is a novel transcatheter device designed to treat mitral regurgitation (MR), a condition that is often severe and can lead to heart failure and death.

To date, 22 patients have been treated with the Tiara valve at medical centres in Canada, the United States and Europe with more implantations scheduled for the coming weeks. The technical success rate in these implantations was 19/22 or 86 per cent. In these technically successful implantations, paravalvular leak levels were reported as mild, trace or absent in 100 per cent of these cases. All cause 30-day mortality in the 19 patients who have reached 30 days postimplant with Tiara is 15.7 per cent (3/19). The three remaining patients treated within the last 30 days are recovering well. Of note, there has been no 30-day mortality reported in any of the last eight patients treated over a month ago.

To date, the longest patient follow-up available is nearing three years postimplant, where the Tiara valve remains fully functional. There have been no reported adverse events related to the valve performance. There have been no frame fractures, or any device performance issues observed with the Tiara in any patient follow-up.

The results noted above were presented today by Dr. Shmuel Banai at the ICI Meeting 2016 in Tel Aviv, Israel. ICI is the premier International Conference for Innovations in Cardiovascular Systems.

Tiara has demonstrated the ability to treat a range of different patient anatomies, including patients with pre-existing prosthetic aortic valves (both mechanical and biological) and those with prior mitral repair surgery including mitral rings, which may be contra-indications for other devices.

"Tiara's unique shape and trigonal tab anchoring system enables the device to be securely implanted with reduced risk of projecting into the LVOT or potentially interfering with prosthetic aortic valves which are commonly present in this patient population," stated Alexei Marko, Neovasc chief executive officer. "Furthermore, the Tiara anchoring system does not rely significantly on the integrity of the native mitral leaflets and therefore can be suitable for certain degenerative MR patients with flail leaflets or calcification. It has also been successfully shown that the design of Tiara makes it suitable for certain cases where mitral rings have been previously implanted in patients."

Tiara II, a 115-patient, non-randomized, prospective clinical study evaluating Tiara's safety and performance, recently received approval to begin enrolling patients in Italy. It is expected that data from this study will be used to file for CE Mark approval for Tiara. CE Mark is the European Union (EU) regulatory approval to commercialize a medical device. It is anticipated that the first implantations in the TIARA II trial will be conducted by the medical team at San Raffaele Hospital in Milan, Italy, in the first quarter of 2017. The company will be initiating additional investigational sites in 2017 as required approvals are obtained.

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 effected throughout Europe. 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.

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