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Neovasc (NVCN) Says Largest Real-World Registry Supporting Reducer Safety and Efficacy Outcomes Published in International Journal of Cardiology

June 18, 2021 9:10 AM EDT

Neovasc Inc. (NASDAQ: NVCN) (TSX: NVCN) ("Neovasc" or the "Company") today announced the publication of an article entitled, "Safety and Efficacy of Coronary Sinus Narrowing in Chronic Refractory Angina: Insights from the RESOURCE Study" in the International Journal of Cardiology.

The article, authored by Francesco Ponticelli, M.D., Maria Cecilia Hospital, Cotignola, Italy, describes long-term outcomes of patients suffering from refractory angina treated with the Neovasc Reducer™ ("Reducer") system. The RESOURCE study is an observational, retrospective registry that includes 658 patients with refractory angina from 20 centers in Europe, the United Kingdom and Israel. The prespecified endpoints of the trial were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score (a measure of chest pain severity) and the rates of procedural success and complications.

At a median follow-up of 502 days after Reducer implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. The procedure was safe and procedural success was achieved in 96.7% of attempts. No cases of intra- or periprocedural-death, myocardial infarction or cardiac tamponade were observed in the study population. No patient required bailout conversion to open surgery. The authors described the study as the largest international real-world registry of patients with refractory angina who were treated with the coronary sinus Reducer.

"The data presented in the RESOURCE study confirm the excellent safety profile of the Reducer device and support good clinical efficacy," said Dr. Ponticelli. "It's encouraging to see the results in this real-world registry are consistent with the randomized data on the Reducer. We can now more confidently tell our patients suffering from refractory angina that there is a safe therapy that may be able to help them feel better."

"We are grateful to the patients and the authors of the RESOURCE study," stated Fred Colen, President & Chief Executive Officer of Neovasc. "The participants in the study represent the types of patients that cardiologists around the world have been struggling to treat. Patients that have tried medicines, by-pass surgery and stents still frequently suffer from debilitating chest pain and have frequently been told there is nothing else for them to try. We are delighted by the real-world evidence that supports our unique and innovative Reducer therapy as a safe and effective option that can now provide relief and an improved quality of life for many of these patients that previously had no further treatment options."



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