67 WALL STREET, New York - August 1, 2014 - The Wall Street Transcript has just published its Medical Devices Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs and Equity Analysts. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Orthopedics and Cardiovascular Medical Devices - Medical Device Innovation and Consolidation Trends - Affordable Care Act - Aging U.S. Population - Medical Technology Innovation - Medical Equipment Growth Opportunities - Efficient Patient Treatment - Bifurcation in Medical Devices
Companies include: Neovasc Inc. (NVCN) and many more.
In the following excerpt from the Medical Devices Report, the CFO of Neovasc Inc. (NVCN) discusses company strategy and the outlook for this vital industry:
TWST: Can you provide a brief overview of the company, and talk about your technology and where it stands?
Mr. Clark: We are a Canadian medical device company, and we have really three distinct arms to our business. The first is the Tiara; this is a leading mitral valve replacement device that will address a market of about four million patients in the U.S. alone. The second is the Reducer; this is a unique device helping approximately two million angina patients worldwide who are not responding to any current treatments. And then thirdly, we have the tissue business, which is a cash-generating contract manufacturing business supporting the rapidly growing TAVI - transcatheter aortic valve implant - market.
TWST: The Reducer, I believe, has CE mark approval.
Mr. Clark: It does.
TWST: When will it have U.S. FDA approval for sale in the U.S.?
Mr. Clark: That's a good question, and really what I can talk about is our development time lines. So the Reducer has just completed its COSIRA study, which was a 104-patient, double-blind, randomized, sham-controlled study that really proved out the efficacy of the device. It was a small patient population with a one-to-one randomization between treatment and control arms. But with that data, we will be able to approach the FDA and initiate an IDE study. We hope to obtain approval for that IDE study in mid-2015. We expect the patient size to be 300 to 500 patients, but really we are not certain yet on the primary end points or the follow-up period that we will be required to have from the FDA. So we really can't offer a time line yet in terms of when the Reducer will be for sale in the U.S.
TWST: Currently, are all your sales of Reducer in Europe?
For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.