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Feb 18, 2021
The Future Is Now: Marc Oczachowski of EDAP TMS On How Their Technological Innovation Will Shake Up Healthcare

Marc Oczachowski is Chairman of the Board and Chief Executive Officer of EDAP TMS, a high-tech medical company which develops, manufactures markets minimally invasive therapeutic ultrasound solutions for urology, tumor removal, localized prostate cancer, and infectious diseases. Thank you so much for joining us Marc! Can you tell us a story about what brought you to this specific career path? I started my career as Area Sales Manager for Sodem Systems which develops power tools for orthopedics. In 1997 I joined EDAP TMS, which designs minimally-invasive medical therapies using ultrasound technology for diseases of the prostate, kidneys, female reproductive organs, and other diseases we continue to research to apply our technology. I started working at EDAP headquarters in Lyon, France as a sales representative and became so fascinated by these technology advancements and excited to introduce such life-changing innovations to doctors and patients around the world. After holding various sales management positions in most regions around the world, I became EDAP COO in 2004 until I was promoted to CEO in 2007. Since that time, I have led the company in developing and perfecting focal robotic HIFU (High-Intensity Focused Ultrasound), which is an incisionless and radiation free device that employs ultrasound technology where soundwaves heat up and burn (ablate) diseased prostate tissue. It is an alternative to traditional prostate cancer treatments such as radiation and radical surgery, which both can cause urinary incontinence and erectile dysfunction. I am proud to say our HIFU technology has been used to successfully treat more than 60,000 men worldwide. Can you share the most interesting story that happened to you since you began your career? Our journey to bring HIFU to the U.S. to get it through the regulatory approval process and reach the point where it would be covered by insurance was challenging and at times painful. Many medical device companies never achieve market success because they fail to anticipate the long, arduous process involved. We had regulatory approval in other countries and about 40,000 men had gone through the procedure. But this had no bearing on the FDA approval process. Luckily, we started this process with our eyes open and knew we were in it for the long haul. It took more than 10 years to finally achieve FDA clearance for our first and second generation of HIFU devices. Even with FDA clearance, the HIFU procedure, which men preferred to surgery and radiation because of their life altering side effects, was not covered by private insurers and Medicare covered a very small portion, which did not include the doctor’s fee. Our next hurdle was to obtain a Category 1 CPT code from the American Medical Association (AMA). This would help facilitate reimbursement from payers. But it’s a process that can take several years. We partnered with our top competitor as well as the American Urological Association and jumped through several hurdles, including getting HIFU clinical studies with different patient populations published in five different clinical journals. With our due diligence, we were able to win approval from the AMA in the first round of our application. The AMA established the new Category 1 CPT code for HIFU which went into effect on January 1, 2021.