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EDAP TMS SA reports developments in robotic energy-based therapies and minimally invasive ultrasound medical devices. The company develops, manufactures, promotes, and distributes systems that combine imaging, robotics, and focused ultrasound, with news frequently centered on the Focal One robotic HIFU platform for prostate focal therapy.
Recurring EDAP updates include HIFU revenue, Focal One system placements, U.S. procedure volumes, clinical evidence for prostate cancer applications, FDA clearances, and product enhancements. News also covers the company’s non-core ESWL lithotripsy and Distribution activities, investor presentations, financial guidance, and board or committee changes affecting the France-based issuer’s Nasdaq-listed American depositary shares.
EDAP TMS SA (Nasdaq: EDAP) has announced that the University of Washington Medicine will implement the Focal One® high intensity focused ultrasound (HIFU) technology for prostate cancer treatment at its UW Medical Center location. This partnership aims to enhance prostate cancer management through advanced imaging and targeted treatments. Marc Oczachowski, CEO of EDAP, emphasized the global adoption of their technology. The Focal One system offers precise ablation capabilities while minimizing side effects, indicating a significant advancement in prostate cancer care.
EDAP TMS SA (Nasdaq: EDAP) announced data from studies presented at the AUA 2021 Annual Meeting indicating the superiority of High-Intensity Focused Ultrasound (HIFU) over radical prostatectomy for prostate cancer treatment.
The studies revealed that Focal One technology maintained better erectile function and urinary continence, with a salvage-treatment-free survival rate of 97.5% compared to 90.3% for radical prostatectomy. EDAP's advancements in minimally invasive therapies reinforce its position as a leader in the therapeutic ultrasound market.
EDAP TMS announced participation in two September 2021 investor conferences. The H.C. Wainwright 23rd Annual Global Investment Conference will be held virtually from September 13-15, with a presentation accessible from September 13 at 7:00 am ET. The Lake Street’s 5th Annual Best Ideas Growth Conference will occur virtually on September 14-15, featuring one-on-one meetings with institutional investors. EDAP TMS specializes in robotic energy-based therapies, including advanced ultrasound technologies for prostate cancer treatment.
EDAP TMS SA reported a revenue increase of 22.5% for the first half of 2021, totaling EUR 20.7 million (USD 24.8 million). Despite strong growth in U.S. HIFU treatment volumes, the HIFU business revenue declined by 15.1% year-over-year. Net income improved to EUR 0.4 million (USD 0.4 million), compared to a net loss of EUR 1.5 million in the prior year. The CMS advisory panel recommended increasing HIFU reimbursement rates significantly for 2022, which could boost future sales. The company maintained a robust cash balance of EUR 45 million (USD 53.3 million) as of June 30, 2021.
EDAP TMS SA (Nasdaq: EDAP) reported preliminary second quarter 2021 revenue of approximately EUR 10.4 million (USD $12.4 million), an 11.8% increase year-over-year, with first half revenue rising 22.5% to EUR 20.7 million (USD $24.8 million). U.S. High-Intensity Focused Ultrasound (HIFU) treatment volumes surged 79% compared to 2020, signaling strong adoption in the market. The company ended the quarter with cash and cash equivalents of EUR 45 million (USD $53.3 million) and announced the appointment of Ryan Rhodes as CEO of its U.S. subsidiary. A detailed financial report is expected on August 25, 2021.
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.
EDAP TMS SA appointed Ryan Rhodes as CEO of its U.S. subsidiary, aiming to boost U.S. expansion. Rhodes brings 14 years of experience from Intuitive Surgical, where he advanced robotic surgery globally. His leadership is expected to drive the adoption of EDAP's Focal One technology for prostate cancer treatment, leveraging recent reimbursement coverage and clinical evidence. Chairman Marc Oczachowski emphasized the need for innovative therapies to improve cancer care standards, with Rhodes expressing optimism about future growth opportunities.
EDAP TMS SA reported a strong first quarter of 2021, generating revenues of EUR 10.3 million (USD 12.4 million), a 35.4% increase year-over-year. The company achieved a gross margin of 42.4% and reported a net income of EUR 0.8 million (USD 0.9 million). The revenue from the Distribution business doubled, reaching EUR 5.6 million (USD 6.7 million). Despite a 6.2% decline in HIFU revenue, EDAP maintains a strong cash position of EUR 24.4 million (USD 28.6 million) as of March 31, 2021, bolstered by a recent $28 million public offering.
EDAP TMS SA (Nasdaq: EDAP) will release its first-quarter financial results for the period ending March 31, 2021, on May 11, 2021, after market close. A conference call and webcast will follow on May 12, 2021, at 8:30 am EDT, featuring remarks from Marc Oczachowski, CEO, and François Dietsch, CFO. EDAP TMS is a leader in robotic energy-based therapies and develops innovative medical devices for prostate cancer treatment. The company aims to provide comprehensive solutions from diagnosis to treatment within the therapeutic ultrasound market.
EDAP TMS S.A. (NASDAQ: EDAP) announced an offering of American Depositary Shares (ADS) at $6.75 per share, totaling 4,150,000 ADSs for approximately $28 million. The offering is expected to close on April 27, 2021, pending customary conditions. Piper Sandler is the sole book-running manager, while B. Riley Securities and Lake Street Capital Markets serve as co-managers. The offering is registered with the SEC, and a prospectus supplement will be filed. This press release does not constitute an offer to sell or solicit offers to buy these securities in any jurisdiction where such actions would be unlawful.