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Oct 7, 2021
Beyond Death Valley: Medtech Veteran Breathes New Life into HIFU Company


Ryan Rhodes, new CEO of EDAP USA was featured in MDDI this week. Rhodes hales from Intuitive Surgical where he helped build the DaVinci Robot brand. He compares HIFU to the early days of robotic surgery: “The HIFU market is still in its infancy, and Rhodes said it reminds him of his early days at Intuitive Surgical, when the Irvine, CA-based robotics company was focused on prostate cancer, specifically radical prostatectomy, which was also a very young market at the time.”

EDAP survived medtech's notorious ‘death valley,’ so what will it take to move the needle in the U.S. market for high intensity focused ultrasound (HIFU)? In an article published by MD+DI in August 2019, Marc Oczachowski wrote that the grueling path from FDA clearance or approval to reimbursement is like a treacherous walk through Death Valley, and that many companies don’t make it through. Oczachowski is the chairman and CEO of EDAP TMS, a French medtech company that makes a robotic high intensity focused ultrasound (HIFU) system for prostate cancer treatment. HIFU has changed the game in prostate cancer, leaving the prostate intact and only destroying the cancer, making it possible for men to retain their sex lives and urinary continence, which is often a casualty of surgery and radiation. Having successfully crossed the notorious "Death Valley" of medtech to get FDA clearance for HIFU and reimbursement for EDAP's minimally invasive procedure, Oczachowski shared some valuable lessons learned from what was ultimately a 14-year journey, starting with the FDA pre-market approval process and later shifting to the more expedient 510(k) clearance pathway, and then "getting through the Death Valley gauntlet to finally win the American Medical Association's approval of a new Category I CPT code for treating prostate cancer, and reimbursement from insurers. But what happens after that treacherous journey? EDAP's commercial efforts have included gathering patient testimony about their positive experience with HIFU, building clinical evidence that demonstrates the long-term benefits of HIFU for prostate cancer, and getting urologists around the world to advocate for HIFU as a significant advancement in the treatment of localized prostate cancer. Yet, EDAP’s share price has lingered primarily in the single digits. Recently, the company brought in Ryan Rhodes to head up its U.S. subsidiary, EDAP Technomed, to help the business reach its full potential in the U.S. market. Rhodes is a medtech veteran and spent 14 years at Intuitive Surgical, where he played a leading role in the global clinical expansion of robotic surgery across multiple specialties, including urology. "Ryan will lead our U.S. organization at a pivotal time as recent reimbursement coverage, key reference centers, and growing clinical evidence help position EDAP to become a widely utilized component of comprehensive prostate cancer treatment," Oczachowski said.