Interview With The CEO: EDAP TMS (EDAP) - Marc Oczachowski

Wall Street Transcript

67 WALL STREET, New York - March 19, 2012 - 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, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Stable Utilization and Personal Health Expenditures - Continued Pricing Pressure - Medical Device Excise Tax - Multinational Penetration in Emerging Markets

Companies include: Cardinal Health (CAH); Positron Corporation (POSC); Abiomed (ABMD); ArthroCare (ARTC); Baxter (BAX); and many more.

In the following brief excerpt from the Medical Devices Report, expert analysts discuss the outlook for the sector and for investors.

Marc Oczachowski was named Chief Executive Officer of EDAP TMS in March 2007. Since joining the company in May 1997, he has held various positions of increasing responsibility including Area Sales Manager, General Manager of EDAP Technomed Malaysia and Chief Operating Officer. Previously, he worked for Sodem System, a worldwide provider in orthopedics devices, as Area Sales Manager. He is a graduate of Institut Commercial de Lyon, France.

TWST: Please start with a brief overview, history and evolution of EDAP TMS.

Mr. Oczachowski: EDAP was founded a little more than 30 years ago in 1979. Our technology platform originated in the French public laboratory, INSERM, and at some university hospitals in Lyon that were doing research on shockwaves to be applied for the fragmentation of kidney stones. Since that time, the company has continued to focus on developing, manufacturing, distributing and servicing its therapeutic ultrasound-technology devices. We designed and pioneered several shockwave technologies for the treatment of kidney stones in the 1980s and the 1990s. In the 1990s, we also invented and created a medical device that uses transurethral microwave thermotherapy for the treatment of benign prostate hyperplasia. This device was sold in the late 1990s and the proceeds were used to support the development of our high-frequency ultrasound, HIFU, device, Ablatherm HIFU, for the treatment of localized prostate cancer. The device obtained CE marking in May 1999 and was released in Europe in early 2000. We are now in the process of seeking U.S. FDA approval for the device. We are approaching the end of a PMA trial, and we are on track to complete the follow-up phase in June 2012. We expect to submit our application to the FDA in the second half of 2012. Concurrently, EDAP continues to develop and innovate in our lithotripsy shockwave device portfolio for the minimally invasive treatment of kidney stones. We received FDA marketing clearance in August 2011 for our new range of lithotripsy products in the U.S., and successfully launched our latest Sonolith i-move.

TWST: Would you tell us in layman's terms, what is HIFU, or high-intensity focused ultrasound, and how EDAP's Ablatherm platform, which utilizes HIFU, is a better alternative for treating prostate cancer?

Mr. Oczachowski: HIFU has several advantages over other therapies for the treatment of prostate cancer. First, HIFU is a noninvasive technology that enables urologists to treat the prostate without cutting the patient. Using our device, the urologist accesses the prostate via the rectum, which is the best route to access the prostate. Second, thanks to the noninvasiveness of the technology, we have a higher probability of preserving the patient's quality of life. The technology is extremely precise and creates small lesions inside the prostate. This method can be adapted for the different treatment strategies that the patient or the urologist is looking for. These strategies range from a focal or partial treatment with nerve-sparing capabilities to a more radical treatment of the whole prostate gland. As of today, we have treated more than 30,000 patients with this technology and have more than 10 years of follow-up data in Europe. We have published many papers in leading scientific publications and presented data at the major urology conferences worldwide. Our clinical results demonstrate that Ablatherm HIFU provides comparable levels of efficacy versus more radical treatment options, such as whole-gland surgery or radiation therapy, but with many fewer side effects, and therefore, a greater chance of preserving the patient's quality of life.

TWST: Would you describe some of other products in EDAP's portfolio right now, including the Sonolith device, and more about the service side of the business?

Mr. Oczachowski: Our extracorporeal lithotripsy device range is named Sonolith. The most recently released devices are the Sonolith i-sys and the Sonolith i-move. The i-sys device is a fully integrated machine lithotripter that is mainly designed to serve big hospitals and university centers. The i-move is a modular machine that uses the same technology and can be utilized on a mobile basis, making the i-move more suitable for private centers and urology partnerships. To give you some background, shockwave lithotripsy is a mature technology that originated in the late 1980s. EDAP has always been focusing on innovation and developing new concepts and new technologies for lithotripsy. As a matter of fact, EDAP released the latest technology available in the market called electroconductive technology in the late 1990s. That technology is based on the principle of creating the shockwave.

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