Vancouver and Minneapolis, November 24, 2021 (GLOBE NEWSWIRE) - Via NewMediaWire - Neovasc Inc. ("Neovasc" or "Company") (NASDAQ, Toronto Stock Exchange symbol: NVCN) It was announced today that the UK’s interventional program plan has issued guidelines at the National Institute of Health and Care Excellence ("NICE") to support the implantation of Neovasc Reducer™ ("Reducer") in appropriate patients with refractory angina pectoris failed or impossible.

NICE's current guidelines on stable angina describe recommendations for the treatment of stable angina that does not respond to treatment. For these difficult to treat patients with stable angina pectoris, NICE's recommendations are limited to solving the psychological factors of the patient's pain. Prior to supporting the new guidelines for coronary sinus reduction, NICE does not support any therapeutic interventions. 

The NICE recommendation is important because it supports the first therapeutic intervention for patients with stable angina who do not respond to treatment. 

According to the new guidance document, “coronary sinus stenosis device implantation is suitable for people whose other treatment options (drugs or surgery) have failed or are impossible (refractory angina). The purpose is to reduce symptoms and improve quality of life.”

An independent advisory committee is responsible for making recommendations for intervention procedures. This committee includes health professionals and people familiar with issues that may affect patients and caregivers. Coronary sinus stenosis device is recommended as a "special arrangement." According to NICE, "...usually performed when the national health service agency considers the procedure to be an emerging practice." It emphasizes the need for informed consent and recommends Clinicians who use these procedures should collect data and enter it into national databases. The guidelines further recommend that patient selection should be done by a multidisciplinary team, and that the procedure should only be done at the center by interventional cardiologists who have received specific technical training.

Jonathan Hill, MD, consultant interventional cardiology consultant at the Royal Brompton & Harefield NHS Foundation Trust in London, UK, commented: “The NICE committee evaluating coronary sinus stenosis devices has extensively reviewed the available clinical data on the Reducer device. Today’s guidance document is for patients in the UK. This is good news for patients with refractory angina. These patients have not yet received a treatment plan under the guidance and support of NICE."  

"Today's NICE guidelines bring new hope to patients," said Fred Colen, President and CEO of Neovasc. “Health authorities around the world recognize NICE’s expertise. We are very pleased that the committee chose to evaluate Reducers and we are satisfied with their decision. The new guidelines, together with the expanded reimbursement granted by NICE earlier this year, will help expand the previous Patients who do not have a good choice get the opportunity of Reducer treatment."

Reducer received the CE mark in the European Union for the treatment of refractory angina pectoris, which is a painful and debilitating disease. Although it is treated with standard revascularization or cardiac drug therapy, it occurs when the blood supply from the coronary arteries to the heart muscle is insufficient This situation. It affects millions of patients around the world. Their lives are usually severely restricted due to their disabling symptoms, and their incidence is rising. The retarder relieves the symptoms of angina by changing the blood flow in the heart myocardium and increasing the perfusion of oxygenated blood to the ischemic area of ​​the myocardium. The placement of the reducer is performed using minimally invasive transvenous surgery, similar to implanting a coronary stent, and is completed in about 20 minutes.  

Although the Reducer is not approved for commercial use in the United States, the FDA granted the Reducer the title of breakthrough device in October 2018. The FDA granted this designation to accelerate the development and review of devices with great potential to provide more effective treatment or diagnosis for life-threatening or irreversible debilitating diseases. In addition, there must be no FDA-approved treatment, or the technology must have significant advantages over existing approved alternatives.  

Refractory angina pectoris, despite maximum medical treatment and no revascularization options, still causes persistent symptoms, affecting an estimated 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases each year.  

Neovasc is a professional medical device company that develops, manufactures and sells products for the fast-growing cardiovascular market. Its products include Reducer for the treatment of refractory angina pectoris, which is not currently on the market in the United States, and has been on the market in Europe since 2015, and Tiara™ for transcatheter treatment of mitral valve disease, and is currently undergoing clinical research in The United States, Canada, Israel and Europe. For more information, please visit: www.neovasc.com. 

Mike.Cavanaugh@westwicke.com 

Sean.Leous@westwicke.com 

Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws, and these statements may not be based on historical facts. The words "anticipate", "anticipate", "estimate", "may", "will", "should", "intend", "believe" and similar expressions used herein are intended to identify forward-looking statements. Forward-looking statements are possible It involves but is not limited to the impact of NICE guidelines, the increase in the incidence of refractory angina and the growth of the cardiovascular market. 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