Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the Neovasc Reducer® (“Reducer”) system has been granted national reimbursement in England as a result of being included in the High-Cost Tariff Excluded Devices (HCTED) national catalogue.
The National Health Service England (NHS England) has a nationwide purchase and supply system for specific categories of high-cost tariff-excluded medical devices used in specialized services designed to support the accelerated adoption of effective new technologies. These are devices NHS England has agreed should be paid for separately from the national tariff for a medical procedure. Hospital providers can now order the Reducer and bill the cost of the device directly to NHS England.
Prof. Jonathan Hill, MD, Consultant Interventional Cardiologist at Royal Brompton & Harefield NHS Foundation Trust, London, U.K., commented, “The clinical data on Reducer therapy, much of it developed in the UK, continues to demonstrate efficacy and excellent safety. Inclusion in the HCTED catalogue is an important step for Reducer therapy and will help new centers to begin utilizing the device. This is good news for the many patients suffering from refractory angina in the UK.”
“Expanding reimbursement for Reducer to enable broader market access has been a cornerstone of the value creation strategy at Neovasc. We are pleased with the NHS decision that follows the positive American Medical Association decision to establish a new Category III CPT code to report the transcatheter implantation of a coronary sinus reduction device,” stated Fred Colen, President and Chief Executive Officer of Neovasc. “We are honored that the NHS has assessed the Reducer as an effective new therapy for patients. The NHS is recognized as a leading authority on health and care excellence. Their decision will help accelerate the adoption of Reducer therapy in the UK and will benefit patients.”
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.
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.Neovasc Reducer System Receives First National Reimbursement in Europe