67 WALL STREET, New York - March 17, 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 - End Market Improvement - Biotech, Pharma and Medical Device Convergence - Changing Competitive Dynamics
Companies include: EDAP TMS SA (EDAP) and many more.
In the following excerpt from the Medical Devices Report, the CEO of EDAP TMS S.A. (EDAP) discusses company strategy and the outlook for this vital industry:
TWST: Now you have this HIFU technology for prostate cancer. Can you distinguish, if you could, between the Focal One and the Ablatherm technology, because my understanding is that they're two different types of technology that are both HIFU-based for prostate cancer? Where does it stand in terms of regulatory clearance?
Mr. Oczachowski: So basically the two products are complementary. Focal One was just released in the EU and launched last year, while Ablatherm is more established, with the current version of Ablatherm having been launched in Europe in 2005. They don't use the same type of imaging. The HIFU technology is a little bit different. The Focal One machine is dedicated to focal treatment, and the Ablatherm machine is more general. Ablatherm is only based on ultrasound guidance and diagnosis of prostate cancer, while the Focal One is based on MRI imaging fusion with ultrasound. So they are a little bit different in terms of imaging capabilities between both machines, and the Focal One is more dedicated to the focal treatment, while Ablatherm is more general and used for the radical treatment of prostate cancer. Thus, they are addressing two different categories of urologists and two different segments of the market for localized prostate cancer.
TWST: When do you anticipate them each having regulatory clearances in the United States?
Mr. Oczachowski: In terms of regulatory clearance, both of them are cleared in Europe using the CE mark, but they are not cleared in the U.S. We started a clinical trial with the U.S. FDA seven years ago using the Ablatherm for primary care patients on localized prostate cancer, and we are now in the final steps of this process. We've conducted a technical trial, we finished a follow-up, we submitted our file, and we went through the administrative review for filing acceptance. So now we are at the last stage of the approval, and we hope to get an answer from the FDA on this clinical study for the Ablatherm before the end of the year. Focal One was just released last year in Europe, and we expect to start...
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