EDAP TMS SA (NASDAQ:EDAP) (“the Company”), the global leader in robotic energy-based therapies, today issued the following letter to shareholders:
To my fellow shareholders:
As we approach mid-year, I would like to take this opportunity to recap a few of our significant accomplishments thus far in 2021 that I believe position us to deliver accelerating long-term growth, particularly in the United States, our most important market.
In April, we completed a successful secondary offering of common stock that raised gross proceeds of approximately $28 million. We intend to use the vast majority this capital to further build out of our U.S. clinical, sales and marketing infrastructure. While we have already announced several high-profile sales in the U.S. to this point, including such renowned institutions like Mt. Sinai and Cleveland Clinic, we are still in the very early stages of tapping into the vast opportunity that our Focal One and related technologies can address.
There are many stages of prostate cancer, and currently there is a dearth of treatment options that exist between active surveillance (watchful waiting) and surgery (radical prostatectomy), the latter of which causes severe side effects that significantly diminish the patient’s quality of life. We, along with the many urologists that champion our technology, believe that high intensity focused ultrasound, or HIFU, can fill this void and provide renewed hope to the approximately three million men living with prostate cancer in the US, with an additional 200,000 that are newly diagnosed every year. Of course, the ultimate success of our U.S. expansion efforts hinges on the quality of the team that we assemble. To that end, we could not have been more pleased to announce just a few weeks ago the hiring of Ryan Rhodes as Chief Executive Officer of EDAP Technomed Inc., our U.S. subsidiary. Ryan brings to the EDAP team decades of highly relevant experience in the medical technology field both launching and driving market acceptance of emerging and disruptive technologies. Notably, his career trajectory includes 14 years at Intuitive Surgical, a true pioneer in the field of robotic-assisted surgery, where he played a leading role in the global clinical expansion of robotic surgery in multiple specialties, including urology. This is a pivotal time for EDAP – we are poised to become a widely used component of comprehensive prostate cancer treatment – and I believe Ryan is the ideal candidate to accomplish this important goal in the U.S.
Ryan and his team will be focused on building HIFU adoption, including significant effort directed towards expanding market access. In addition, since the long-term success of any new technology in the U.S. relies on the successful navigation of a complex reimbursement system, we are also focused on expanding coverage for HIFU and securing future reimbursement rates that are reflective of the value that we add through improved outcomes for patients. We previously announced the establishment of a Category 1 CPT code and reimbursement to physicians performing ablation of malignant prostate tissue with HIFU in the U.S., effective January 1 of this year. With HIFU reimbursement dynamics now clarified, we believe this will contribute to accelerating growth.
In closing, I could not be more pleased with the steps that we are taking to establish a strong foundation for growth in the U.S., and I am humbled by the trust that you, our shareholders, have placed in us to successfully execute against this objective. Our last shareholder update focused on COVID-19 and the steps we took to navigate through that crisis. We are now acutely focused on the future and the significant opportunities that are in front of us. I would like to thank you for your continued support and look forward to a mutually successful year and beyond.
Sincerely,
Marc Oczachowski
Chairman & Chief Executive Officer
