Neovasc Reducer Therapy for Refractory Angina Marks
300th-Patient Milestone in Germany
NASDAQ, TSX: NVCN
VANCOUVER, MINNEAPOLIS and FRANKFURT, September 25, 2020 – Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), today announced that the 300th patient in Germany has been treated with the Neovasc Reducer™, a medical device designed to treat patients with refractory angina.
“This is an important milestone that underscores the growing penetration of Reducer in Germany’s cardiovascular market,” said Fred Colen, President and Chief Executive Officer of Neovasc. “We are seeing a steady increase in adoption and are gratified that we can contribute to improved quality of life for patients who are often severely restricted by the debilitating symptoms of refractory angina.”
Dr. Felix Woitek, Senior Physician, and the team at Herzzentrum Dresden, Germany implanted the 300th Reducer. “We see a growing number of patients presenting with refractory angina, despite optimal medical treatment and revascularization therapies including coronary stenting and bypass surgery,” said Dr. Woitek. “Reducer offers a new treatment option for these patients, and we are extremely pleased with the results to date, which are consistent with the published data. The majority of our patients report being able to lead a more active life, and for many of them the results are life-changing.“
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 within the myocardium of the heart and 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.
While the Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to the 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 of 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.
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. 1
1T. J. Povsic, S. Broderick, K. J. Anstrom et al., “Predictors of long?term clinical endpoints in patients with refractory angina,” Journal of the American Heart Association, vol. 4, no. 2, article e001287, 2015.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. The Company is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently commercially available in the United States (2 U.S. patients have been treated under Compassionate Use) and has been commercially available in Europe since 2015, and Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com. Click here for a link to the most recent corporate update.