Neovasc (TSX:NVCN)(NASDAQ:NVCN) is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. The company’s products include Neovasc Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States, and the Tiara for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the U.S., Canada, Israel, and Europe.
The company’s core strategy is to focus on establishing confidence with Neovasc’s stakeholders, and to continue the development and commercialization of the company’s products. Through the Tiara and the Reducer, Neovasc is working on providing minimally invasive medical devices for a cardiovascular market that the company believes is both growing and underserved by current treatment solutions. Neovasc was incorporated in 2000 and is headquartered in Richmond, Canada.
Treatment of refractory angina
With regards to the Reducer, the company is continuing therapy development and has successfully supplemented a clinical study with additional clinical experience. Neovasc is targeting a commercial launch in Europe. Improving revenue growth in Europe and providing reimbursement initiatives in other international markets could significantly increase the company’s stock price.
Neovasc is also seeking strategic alternatives and alliances to build on the growing enthusiasm in the market for the Reducer in order to broaden and deepen therapy penetration in Europe and the Middle East. The company is evaluating several studies with U.S. Food and Drug Administration (FDA) and approvals could result in a sales boost for Neovasc.
Treatment of mitral valve disease
The company’s clinical experience of the Tiara was successful, and the clinical data study was used by the company to file for commercialization. Enrollment in the clinical study was closed in 2019 with a total of 27 patients being treated for the next five years. The company is targeting a European regulatory decision for Tiara in the first half of 2021, although it provides no assurance that European regulatory approval will be granted in the time frame anticipated by management or granted at any time in the future. If the development of the Tiara system for preclinical bench and animal studies leads to successful completion, this could be followed by human compassionate use in the second half of 2021.
Robust product pipeline
Product development activities have recently started at the company for the development of the Tiara system, focused on a suitable and novel transfemoral delivery system. Further, the company is working on few important but minor changes to the Tiara valve to make it deliverable and to further penetrate the patient population. These development activities are taking place at the company’s Vancouver facility. Furthermore, engineering resources are continuing to support manufacturing for both the Reducer system, and the Tiara system for clinical studies.
Neovasc’s specialty medical devices products could have a revolutionary impact on the cardiovascular industry in Europe, Canada, the U.S., and internationally. The company’s Tiara technology is likely to be widely used for the transcatheter treatment of mitral valve disease. Further, Neovasc’s Reducer is also to be likely used for the treatment of refractory angina in the future.