EDAP Issues Letter to Shareholders

Rhea-AI Summary

EDAP TMS SA (Nasdaq: EDAP) announces significant achievements in 2021, including a successful secondary offering that raised approximately $28 million to enhance its U.S. market capabilities. The company has made notable sales to prominent health institutions like Mt. Sinai and Cleveland Clinic. The hiring of Ryan Rhodes as CEO of the U.S. subsidiary aims to accelerate high intensity focused ultrasound (HIFU) adoption in prostate cancer treatment. Additionally, a Category 1 CPT code was established for HIFU reimbursement, effective January 1, 2021.

Positive

• Raised approximately $28 million from a successful secondary offering.
• Secured sales with renowned institutions including Mt. Sinai and Cleveland Clinic.
• Hired industry veteran Ryan Rhodes as CEO to bolster U.S. expansion.
• Established a Category 1 CPT code for HIFU reimbursement effective January 1, 2021.

Negative

• None.

Successful financing and hiring of MedTech industry veteran Ryan Rhodes to drive accelerated U.S. expansion efforts

LYON, France, July 20, 2021 -- 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

About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, and us.hifu-prostate.com.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device, as well as the length and severity of the recent COVID-19 outbreak, including its impacts across our businesses on demand for our devices and services. Factors that may cause such a difference also may include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.

Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com

FAQ

What were EDAP's financial achievements in July 2021?

In July 2021, EDAP TMS raised approximately $28 million through a secondary offering to enhance its U.S. market infrastructure.

Who was appointed as the new CEO of EDAP's U.S. subsidiary?

Ryan Rhodes was appointed as the CEO of EDAP Technomed Inc., the U.S. subsidiary.

What institutions have made high-profile purchases from EDAP?

EDAP secured sales from notable institutions such as Mt. Sinai and Cleveland Clinic.

What reimbursement code was established for EDAP's HIFU technology?

A Category 1 CPT code for HIFU reimbursement was established, effective January 1, 2021.