NVCN stock is making big swings in pre-market trading on December 31, 2019, after the company announced that it has submitted a Premarket Approval Application to the FDA.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval.
Neovasc Inc. (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, today announced the submission of a Premarket Approval application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for its Neovasc Reducer™ (“Reducer”) medical device for the treatment of refractory angina. The submission also includes a request for an Advisory Panel meeting.
“This submission marks an important milestone in our effort to bring Reducer to the U.S. market, where it is estimated that there are up to 1.8 million patients with refractory angina,” said Fred Colen, President and Chief Executive Officer of Neovasc. “These patients have traditionally had no options – they are either unsuitable for revascularization or continue to suffer with angina following revascularization procedures. The Reducer provides potential 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.”
The PMA for Reducer includes clinical data from the COSIRA 104 patient randomized, double-blind, sham-controlled trial, the ongoing REDUCER-I European Post-Market study, with over 200 patients currently enrolled with up to 5 years of follow-up, and supportive clinical evidence from multiple peer reviewed publications on Reducer.
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.
On December 17, 2019, Neovasc announced that the Neovasc Reducer™ (the “Reducer”) was featured in a special issue titled: “The Future of Medicine” of National Graphic Magazine, published in December 2019. An image of the Reducer was accompanied by a case study of a patient who was implanted with the Reducer. Neovasc’s Medical Director, Prof. Shmuel Banai, MD, Director of the Division of Cardiology and the Head of Interventional Cardiology at the Tel Aviv Medical Center, Tel Aviv, Israel, is also prominently featured.
Fred Colen, President and Chief Executive Officer of Neovasc, stated, “As one of the most prestigious magazines covering science, geography, history, and world culture, National Geographic is an outstanding venue to introduce readers to the Reducer, a CE-marked device commercially available in Europe, but not yet available for commercial use in the United States. The entire Neovasc team was pleased to see both Professor Banai and Reducer featured in the article: ‘Pain: Scientists are unravelling new ways to treat it.’”