EDAP TMS SANASDAQ: EDAP

When combined with EDAP's Focal One platform, Avenda's Unfold AI enables more accurate and patient-specific treatment options.

First Unfold AI ® -Assisted Focal One procedures successfully performed at the UCLA School of Medicine FDA-cleared Unfold AI enables urologists to provide tailored, patient-specific Robotic HIFU ablation for prostate cancer patients EDAP and Avenda Health to present Unfold AI-Assisted Focal One simulated procedures at the 2024 Joint Meeting of the Focal Therapy Society & Society of Urologic Robotic Surgeons in Washington, DC September 19-21, 2024 LYON, France, September 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, and Avenda Health (“Avenda”), a leading AI healthcare company, today announced a collaboration agreement for the purpose of offering personalized prostate cancer care, utilizing Avenda's groundbreaking AI technology, Unfold AI, to launch the world's first AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures. Avenda Health's Unfold AI is a multimodal AI decision support platform cleared by the U.S. Food and Drug Administration (FDA) that brings “superhuman” abilities to cancer surgeons and oncologists to power the future of cancer care.

LYON, France, August 29, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced that Ryan Rhodes, Chief Executive Officer, is scheduled to participate in a fireside chat and host 1x1 investor meetings at the H.C. Wainwright 26th Annual Global Investment Conference, which is being held September 9-11, 2024, in New York City.

Record Q2 2024 total worldwide revenue of EUR 15.8 million (USD 17.0 million) increased 10.6% over Q2 2023 Record first half 2024 total worldwide revenue of EUR 30.7 million (USD 33.1 million) increased 5.6% over first half 2023 Strong Q2 2024 U.S. Focal One® HIFU procedure growth of +63% year-over-year Company to host conference call and webcast today, August 28th, at 8:30 a.m. EDT LYON, France, August 28, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the second quarter of 2024.

Robotic HIFU therapy continues to maintain an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies in patients with deep infiltrating endometriosis At three months post procedure, the study's primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met Significant improvements were observed across primary and secondary outcome measures (endometriosis and digestive symptoms) across the entire study population at three months The Phase 3 study continues as planned per protocol, with patients from the Sham treatment arm electing HIFU therapy LYON, France, July 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating endometriosis. The Phase 3 study is a 60-patient comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels.

EDAP TMS (NASDAQ: EDAP) Q1 2024 Earnings Call Transcript on May 16, 2024 at 8:30 AM ET featuring Company Representatives John Fraunces, Ryan Rhodes, and Ken Mobeck. Conference Call Participants include Michael Sarcone, Frank Takkinen, Jason Bednar, and Swayampakula Ramakanth. Welcome to the EDAP TMS First Quarter 2024 Earnings Conference Call.

EDAP TMS reported Q2 2023 revenues of $15.52 million, a 0.9% YoY growth that missed estimates. In Q2 2023, HIFU's total revenue growth stood at 63.6% (YoY). The procedure growth of Focal One shot up 85% (YoY). EDAP's share price has declined 21.50% YoY and is trading almost 50% below its 52-week-high.

EDAP TMS S.A. is a French developer of minimally invasive medical devices for urological diseases. The company operates in three segments: High Intensity Focused Ultrasound, Extracorporeal ShockWave Lithotripsy, and Distribution Services. High Intensity Focused Ultrasound is gaining traction as a treatment for prostate cancer and has potential applications in rectal endometriosis.

EDAP TMS S.A. (NASDAQ:EDAP ) Q2 2023 Earnings Conference Call August 24, 2023 8:30 AM ET Company Participants John Fraunces - Managing Director of LifeSci Advisors, LLC Ryan Rhodes - CEO Ken Mobeck - CFO, U.S. Subsidiary Francois Dietsch - CFO Conference Call Participants Michael Sarcone - Jefferies Frank Takkinen - Lake Street Capital Markets Jason Bednar - Piper Sandler Swayampakula Ramakanth - H.C.