Neovasc Announces Treatment of 1,000th Refractory Angina Patient with Neovasc Reducer™

VANCOUVER, - Neovasc Inc., 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, announced today that 1,000 patients diagnosed with refractory angina have been treated with the Neovasc Reducer™ ("Reducer").  These patients have been treated in Europe, the Middle East, Canada, and the United States (the two patients treated in the U.S. were treated under compassionate use).  Three patients were treated simultaneously by Dr. Francesco Giannini and Prof. Antonio Colombo at the Maria Cecilia Hospital in Cotignola, Italy, Prof. Marco Valgimigli at the Inselspital Universitätsspital Bern, Switzerland and Prof. Javier Escaned at the Hospital Clinico San Carlos in Madrid, Spain.

"Regular bouts of angina can significantly impact a patient's quality of life. This is especially true when these people suffer from refractory angina, which is angina that persists despite optimal drug therapy and revascularization. For many of these patients, angina changes their life unexpectedly and the prospect of living with this pain for the rest of their lives is difficult to bear," says Prof. Banai, Director Division of Cardiology at the Tel Aviv Medical Center and Medical Director for Neovasc.

"We are pleased to have treated the 1,000th patient to receive the Reducer therapy at the Inselspital Universitätsspital Bern". The procedure was performed by Prof. Marco Valgimigli and is expected to offer symptomatic relief from invalidating angina after coronary artery bypass surgery 19 years ago and multiple percutaneous coronary interventions afterwards.

The Reducer therapy now totals medical evidence spanning 1,000 patients and 14 years of follow up. This substantial evidence demonstrates that the Reducer alleviates refractory angina symptoms in about 80% of the treated patients. The procedure lasts about 20 minutes and has been shown to be very safe and straightforward.

"It is important to note that the clinical results obtained in a randomized trial have been replicated in 'real life' hospital settings across several countries," stated Dr. Giannini. "The fact that the Reducer therapy is effective and safe is very important for refractory angina patients, as this chronic condition significantly impairs their quality of life and they have very limited treatment options."

"I have been following the development of the Reducer therapy for many years. I am pleased to see how its clinical data has continued to build. With the 1,000th patient treated milestone, I believe it is time we encourage our colleagues and societies to inform their refractory angina patients that there may be a treatment option available to them today," says Prof. Colombo.

"There is great interest in the cardiology community for the Reducer device. Published data from real-world experience, which has now reach 1000 patients, supports the very solid evidence obtained in the randomized, sham-controlled COSIRA trial on the value of coronary sinus reduction in patients with refractory angina. this is particularly important for this group of patients with limited options", stated Prof. Escaned.

"We are pleased to reach this milestone and view the increasing use of the Reducer to treat refractory angina patients around the world as a testament to the positive impact the device has had on patients compared to other treatment options.  This momentum is mostly attributable to the commercialization strategy that we have implemented for the Reducer in Europe, which has generated growing interest among leading cardiologists," stated Fred Colen, CEO of Neovasc.

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. The Reducer is not commercially available in the United States, the FDA however granted the Reducer the Breakthrough Device Designation in October of last year.  Refractory Angina 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.