Neovasc Announces Peer Reviewed Publication in the International Journal of Cardiology Demonstrating that the Neovasc Reducer™ Improves Diastolic Function in patients suffering from severe angina

VANCOUVER - Neovasc Inc. ("Neovasc" or the "Company"), 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 announced that the International Journal of Cardiology (the "IJC") has published a peer reviewed article demonstrating that coronary sinus ("CS") narrowing through the use of the Neovasc Reducer™ (the "Reducer") improves diastolic function and relaxation of the heart. The article title is: "The impact of coronary sinus narrowing on diastolic function in patients with refractory angina."

"We are pleased to report evidence that CS narrowing may also improve diastolic function in patients with chronic refractory angina and proven myocardial ischemia. We believe this study has the potential to further encourage cardiologists to treat refractory angina patients with coronary sinus narrowing without the concern of adverse effects on the relaxation properties of the heart," commented Dr. Shmuel Banai, Medical Director of Neovasc.

The purpose of the study was to evaluate the impact of CS narrowing on stiffness and relaxation abilities of the left ventricle (diastolic function) in patients with myocardial ischemia and severe refractory angina treated with the Reducer. The study demonstrated that treatment with the Reducer may lead to improvement in diastolic function and echocardiographic parameters of left ventricular relaxation. The results of this trial may preclude the speculation that coronary sinus narrowing might adversely affect relaxation of the heart muscle. The study clearly indicates the opposite, and demonstrates that the Reducer not only improved angina status and quality of life of these patients, but also resulted in a significant improvement in mean diastolic function. The observed improvement in the relaxation properties of the heart are most probably secondary to the improvement in blood perfusion to ischemic territories of the heart muscle which is known to be the effect of 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 medical therapy. 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 improving 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.

While the Reducer is widely used in Europe, it is not yet approved for commercial use in the United States. The U.S. Food and Drug Administration ("FDA") granted Breakthrough Device designation to the Neovasc Reducer in October 2018. This designation is granted by the FDA in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.  In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives for the FDA to grant Breakthrough Device designation.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

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.

Sources
  • Neovasc Inc.

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