®NASDAQ, TSX: NVCN
VANCOUVER, Oct. 22, 2019 – Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), 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 the Neovasc Reducer™ (“Reducer”) was featured in multiple presentations during the symposium “A Proven Evidence-based therapy when Angina Persists”, held this month at the National Congress of the Italian Society of Interventional Cardiology (GISE) in Milan, Italy.
A prestigious team of key opinion leaders reviewed the latest results of the Reducer Therapy. The highlights showed that 50% of the patients improved by 2 CCS Classes or more while 83% of patients improved by 1 CCS Class or more. Seventeen percent (17%) did not respond to the therapy. Additionally, the average CCS score decreased from 3.2 to 1.7 (p<0.001). “Putting together this data with the significant dissatisfaction with current therapies, gives us tremendous excitement for the potential for Reducer in the market place,” said Professor Shmuel Banai, MD, Medical Director, Neovasc.
In selected presentations:
Prof Shmuel Banai, Director, Division of Cardiology Tel-Aviv Medical Center, and Neovasc Medical Director, presented the history and rationale of coronary sinus narrowing for the treatment of angina. In 1948, American Cardiac Surgeon, Claude Schaffer Beck, developed an effective treatment for patients with disabling angina by creating a surgical narrowing of the coronary sinus. Between the years 1948 to 1964 Dr. Beck successfully used this procedure on more than 1,000 patients with coronary heart disease. In 1952, Dr. Beck became the first to receive the title of professor of cardiovascular surgery in the United States. More recently, Neovasc developed non-surgical methods to narrow the coronary sinus in Europe and Canada. These methods proved effective, enhancing blood supply to the ischemic heart, increasing quality of life and protecting the heart while reducing infarct size.
Pr. Sergio Berti, Fondazione Toscana G. Monasterio, based on recent survey data of clinical cardiologists in the Milan area, reinforced that many patients suffer from angina despite optimal therapy. The clinical cardiologists polled estimate that as many as 12% of their angina patients are refractory to currently available therapies. On average, these physicians each had 20 such patients, of which approximately 50% were not satisfied with their current therapy. Physicians confirmed they would likely have sent these patients for a definitive interventional treatment, if they were aware of such a therapy. The conclusion of the survey was that there are still many patients with refractory angina, who are not satisfied with their quality of life or their current therapy, and who could potentially benefit from the Reducer. These leading cardiologists reinforced that the suffering of patients has a significant impact on their everyday life. As a measure of that, these patients on average return for a consultation on a monthly basis.
Dr. Francesco Giannini, GVM Care & Research Maria Cecilia Hospital – Cotignola, reviewed the technical and procedural aspect of the Reducer Therapy. During his presentation, Dr. Giannini reinforced the strong safety profile of the procedure.
On behalf of the investigators, Dr. Gianpiero D’Amico, University of Padua, presented the Italian Society of Interventional Cardiology (GISE) Multi-Center study on the “Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina.” One hundred eighty three patients suffering from severe refractory angina were treated with coronary sinus narrowing by Reducer implantation in 16 medical centers across Italy. Presented data demonstrated a 98% technical success rate. Efficacy data at median follow-up of 564 days showed significant improvements in angina severity with minimal rates of complications. Results, based on the Canadian Cardiovascular Society Class (a measure of the severity of angina) (“CCS Class”), showed that 50% of the patients improved by 2 CCS Classes or more, 83% of patients improved by 1 CCS Class or more and 17% did not respond to the therapy. The average CCS score decreased from 3.2 to 1.7 (p<0.001). Quality of life as assessed by the Seattle Angina Questionnaire (SAQ) also improved significantly across all 5 domains (p<0.001). Data comparing the CCS Class improvement results of the Italian registry to seven other previously published Reducer studies demonstrated consistent results across all studies.
Finally, the current President of GISE, Pr. Giuseppe Tarantini, University of Padua, reinforced the importance of the new European Society of Cardiology guidelines for the Reducer Therapy and the importance of this therapy for patients who currently have few treatment options.
“We are delighted that another significant independent study of real-world data continues to support the extensive body of clinical evidence for the efficacy of the Reducer.” said Fred Colen, President and Chief Executive Officer of Neovasc. “We have a clear call to action supporting the physician community, and in particular the general cardiologists, to inform the many patients who are suffering from angina. The Reducer may be a new, safe and symptom-improving option. We continue to be actively engaged with the U.S. Food and Drug Administration (“FDA”) and we have completed another informative discussion earlier this month. This new data from Italy will be presented in our ongoing discussions with the FDA as we work for regulatory approval for the Reducer in the United States.”
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 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 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.
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 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.
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 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.
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.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, statements regarding the potential benefits to the Reducer as a result of many refractory angina patients not being satisfied with their quality of life or current therapies, that there may be a new, safe and symptom improving option in the Reducer, the future approval for the Reducer in the United States, the growing cardiovascular marketplace and the growing incidence of refractory angina. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F and in the Management’s Discussion and Analysis for the three and six months ended June 30, 2019 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Neovasc Inc.