EDAP TMS SA - EDAP STOCK NEWS

EDAP TMS SA announced a significant increase in Medicare reimbursement for the Focal One HIFU prostate ablation procedure, effective January 1, 2023. The reimbursement will rise to $8,558 per procedure, a 90% increase from the current $4,506. This adjustment reflects CMS's recognition of the value of HIFU therapy, potentially expanding access to patients and influencing commercial payors. The management views this as a crucial step for prostate cancer treatment and plans to discuss its impact during the upcoming Q3 2022 results conference call.

EDAP TMS SA (Nasdaq: EDAP) will host a urology expert panel and live demonstration of its Focal One® technology on September 29, 2022, at 8 AM ET at the Langham Hotel in New York City. The event will feature presentations from the U.S. CEO and leading prostate cancer experts, followed by a live Q&A session. EDAP TMS is recognized for its advancements in robotic therapeutic ultrasound and offers a comprehensive solution for prostate cancer treatment. The company aims to enhance market acceptance of its HIFU devices amidst ongoing challenges from the COVID-19 pandemic.

EDAP TMS S.A. announced a public offering of 2,666,667 American Depositary Shares (ADSs) priced at $7.50 each on September 22, 2022. The offering aims to raise approximately $20 million before expenses. Jefferies LLC will act as the sole book-running manager and has a 30-day option to purchase an additional 400,000 ADSs. The offering's closing is anticipated on September 27, 2022, subject to customary conditions. The initial registration statement for this offering was filed with the SEC in April 2021.

EDAP TMS announced a public offering of its American Depositary Shares (ADSs) on September 22, 2022, with Jefferies LLC as the sole book-running manager. The offering's completion and terms are subject to market conditions, and there are no assurances regarding these aspects. A shelf registration statement effective since April 7, 2021, is in place for the offering. Investors are advised to review the preliminary prospectus supplement and associated documents before purchasing. The offering will not take place in Europe, and forward-looking statements are subject to various uncertainties.

EDAP TMS SA (Nasdaq: EDAP) has reported a strong financial performance for the second quarter of 2022, achieving approximately EUR 14.2 million (USD 15.0 million) in revenue, marking a 36.7% increase year-over-year. The company experienced a 79% growth in HIFU revenues compared to the same period in 2021. Notably, the Centers for Medicare and Medicaid Services proposed raising the Focal One HIFU reimbursement to APC Level 6, which is expected to significantly enhance patient access. As of June 30, 2022, EDAP held cash reserves of EUR 46.3 million (USD 48.5 million).

EDAP TMS SA (Nasdaq: EDAP) will announce its Q2 2022 financial results on August 24, 2022, after market close. A conference call and webcast will follow on August 25 at 8:30 am EDT, featuring key executives including Marc Oczachowski, Ryan Rhodes, and François Dietsch. EDAP TMS is recognized for its advancements in robotic energy-based therapies and ultrasound technology for medical devices, particularly in prostate cancer treatment.

EDAP TMS SA (Nasdaq: EDAP) announced that the proposed outpatient payment rule by CMS for CY23 would increase Medicare reimbursement for the Focal One HIFU procedure from $4,506 to $8,711 per case. This change reflects the procedure's value compared to more invasive treatments and is expected to enhance patient access to focal HIFU. With comments due by September 30 and a final rule expected in November, the new rates will take effect on January 1, 2023. This increase may influence commercial payors and improve overall market acceptance for EDAP's HIFU devices.

EDAP TMS SA (Nasdaq: EDAP) announced its participation in two significant urology congresses: the EAU Congress in Amsterdam from July 1-4, 2022, and the SRS Congress in Orlando from June 30 to July 3, 2022. At these events, EDAP will showcase its Focal One® Robotic Focal HIFU technology, emphasizing its role in prostate cancer treatment. Key presentations will include a randomized trial comparing ExactVu micro-ultrasound with MRI and discussions on the growing adoption of Focal One as a minimally invasive therapy. This involvement is expected to enhance EDAP's visibility and customer engagement in the urology space.

EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced that Prof. Gil Dubernard will present at the 6th European Endometriosis Congress in Bordeaux, France, on June 17. The presentation will focus on the potential of High Intensity Focused Ultrasound (HIFU) as a treatment for symptomatic rectal endometriosis. CEO Marc Oczachowski emphasized the importance of this research, which suggests that HIFU may provide a less invasive option for patients suffering from endometriosis.