Neovasc Provides Further Update on Reducer™ Program for Treatment of Refractory Angina

VANCOUVER,  - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today provided a further update on its Neovasc Reducer™ (the "Reducer") program for the treatment of refractory angina. 

As previously announced, following guidance recently received from the FDA, Neovasc intends to seek the FDA's designation of the Reducer as a HUD for CCS Class IV refractory angina patients. If it is possible and if the FDA grants HUD designation for the Reducer for CCS Class IV patients, and if a subsequent HDE application is approved by the FDA as well, Neovasc expects to begin commercializing the Reducer in the U.S. by early 2020. The maximum total U.S. annual addressable market with a Reducer HDE under a CCS Class IV would be limited, by statute, to a maximum number of patients per year in the U.S. with the most severe refractory angina, and is therefore limited to an estimated US$80 million of potential revenue per year.

"Should the FDA grant the Class IV HUD designation to the Reducer, we expect to be in a position to offer treatment to those patients with CCS Class IV refractory angina in early 2020," said Fred Colen, CEO of Neovasc.  "We view this as a significant market opportunity for Neovasc. Concurrently, we will explore an alternate investigational device exemption clinical study design, in conjunction with our supportive U.S. cardiologists, with the intent of further expanding the patient population to CCS Class III patients and to seek full approval for the CCS Class IV patients over time."

There can be no assurance that the HUD or HDE applications that Neovasc plans to file will be approved by the FDA, that the FDA will classify the Reducer for CCS Class IV refractory angina patients as a HUD, or that such applications will be approved on the timelines described above. In the event that the HUD and HDE applications are approved by the FDA, there can be no assurance that Neovasc will be successful in commencing commercialization of the Reducer in the U.S. on the timeline described above or at all, or of the total addressable market size for the Reducer.

About Reducer
The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow in the heart's circulatory system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and is completed in approximately 20 minutes.

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. For more information, visit: www.neovasc.com.