Neovasc Receives FDA Approval for COSIRA-II Clinical Trial

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

Neovasc Inc. NVCN is a medical device company focused on developing, manufacturing, and marketing products for the cardiovascular market. Neovasc is a leading developer of minimally invasive transcatheter mitral valve replacement technologies as well as minimally invasive devices for the treatment of refractory angina.

Refractory angina (RA) pectoris affects millions of people worldwide and is a debilitating condition. Currently available medical or surgical treatments are expensive and don’t always alleviate the severe chest pain many patients suffer from. 

Neovasc has developed proprietary solutions that target minimally invasive transcatheter mitral valve replacement technologies and minimally invasive devices to help treat RA and improve successful outcomes.

The device targeted at treating RA, called Neovasc Reducer™, works to provide relief by altering blood flow within the heart's myocardium and increasing the perfusion of oxygenated blood to ischemic areas of the heart. Placement involves a minimally invasive transvenous procedure that lasts approximately 20 minutes. Patients treated with the Reducer have typically exhausted all available surgical options and thus are frequently referred to as “no option” patients. The Reducer offers a new solution, and new hope, for the millions of patients afflicted by refractory angina.

Last month, Neovasc received U.S. Food and Drug Administration (FDA) approval for the Investigational Device Exemption (IDE) Clinical TrialCOSIRA-II. Following multiple discussions with FDA over the past several months, the approved protocol for the COSIRA-II study is designed to answer key questions arising from the October 2020 Circulatory Systems Devices Panel Meeting regarding the Neovasc Reducer™. The approval of the supplement is consistent with Neovasc’s internal target, and the company remains on track to enroll the first patient in the trial late this year.

COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Neovasc Reducer for patients suffering from refractory angina. The primary endpoint of the trial is a change in exercise tolerance testing time via a modified Bruce protocol between baseline and 6-month follow-up.

The study is planned to enroll approximately 380 patients at up to 50 sites in the United States and will also include limited sites outside of the United States. The trial will include patients with Canadian Cardiovascular Society Class III-IV refractory angina on maximally tolerated medical therapy without further options for revascularization via coronary intervention or bypass grafting. The principal investigators of the trial are Gregg Stone, M.D., Mt. Sinai Health System, New York, NY, and Tim Henry, M.D., Christ Hospital, Cincinnati, OH.

This latest development comes after the Neovasc Reducer received its first national reimbursement from England’s National Health Service (NHS) in June 2021.

The NHS included the Reducer in the High-Cost Tariff Excluded Devices (HCTED) national catalog, a purchase and supply system for medical devices designed to support the accelerated adoption of effective new technologies. Hospital providers can now order the Neovasc Reducer and bill the cost of the device directly to the NHS.

The Reducer is CE-marked in the European Union for the treatment of RA, a debilitating condition that occurs when the coronary arteries won’t deliver enough blood supply to the heart, despite treatment with standard revascularization or cardiac drug therapies.

Neovasc generated revenue of about $633,000 in Q2 2021, up 123% from the same period in 2020 and a sequential 40% increase from Q1 2021. Although larger competitors like Medtronic PLC MDT and Abbott Laboratories ABT work in the cardiovascular device sector, Neovasc’s recent $72 million capital raise is also drawing the attention of investors and solidifying the company position.

Learn more about Neovasc’s investor relations here.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.