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EDAP TMS SA (NASDAQ: EDAP) is a global leader in therapeutic ultrasound with over 30 years of experience. The company develops, manufactures, promotes, and distributes minimally-invasive medical devices for urology using advanced ultrasound technology. With a robust presence worldwide through a network of corporate offices, subsidiaries, and distribution partners, EDAP TMS is committed to innovation and excellence.
EDAP TMS operates through three main divisions:
- HIFU (High-Intensity Focused Ultrasound): This division focuses on the development and marketing of devices for the non-invasive destruction of tumors. Key products include Ablatherm, Ablatherm Fusion, and the Focal One, which is the latest addition designed for ideal focal therapy of localized prostate cancer.
- ESWL (Extracorporeal ShockWave Lithotripsy): This division manufactures and services the Sonolith range of lithotripters, which are used for the treatment of kidney stones.
- Distribution: This division markets complementary products such as lasers, micro-ultrasound systems, and other medical devices from third-party suppliers.
EDAP TMS is known for its strong patent portfolio thanks to continuous investment in research and development. The company collaborates with globally acclaimed medical research institutions to push the boundaries of medical technology. Financially, EDAP TMS reported a gross profit of EUR 24.4 million (USD 26.4 million) for the year ending December 31, 2023, reflecting a slight increase from the previous year. However, the gross profit margin declined due to inflationary pressures and investments in U.S. operations to support long-term revenue growth.
Recent achievements include the launch of the Focal One and strategic partnerships to expand its product reach. The company’s commitment to innovation and patient care makes it a significant player in the medical device industry.
EDAP TMS SA announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has established a Category 1 CPT code for reimbursement of High-Intensity Focused Ultrasound (HIFU) procedures for malignant prostate tissue, effective January 1, 2021. Physician reimbursement for HIFU will average $943, approximately 30% higher than for cryotherapy. Hospitals will receive around $4,500 per HIFU procedure, reflecting a 6% increase from 2020. This move is expected to drive adoption of EDAP's Focal One technology.
EDAP TMS SA (Nasdaq: EDAP) reported its strongest revenue quarter of 2020, with total revenue of EUR 9.4 million (USD 11.2 million), despite an 8.5% decrease year-over-year. Growth was noted in HIFU procedure revenues, complemented by significant sales to Mount Sinai Health System and USC. The company initiated a Phase 2 clinical trial for Focal One® targeting deep rectal endometriosis and ended the quarter with a strong cash position of EUR 19.9 million (USD 23.4 million). Caution was expressed regarding potential impacts on operations due to rising COVID-19 cases.
EDAP TMS SA announced an exclusive distribution agreement with AB Medica, enhancing the availability of its High Intensity Focused Ultrasound (HIFU) technology in Italy, one of Europe's largest medical device markets. This partnership complements AB Medica's existing portfolio, including robotic surgery solutions and ExactVu. The collaboration is expected to boost the adoption of EDAP's HIFU products in Italy, further establishing the company in the urology field.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced its participation in the Jefferies Virtual London Healthcare Conference from November 17-19, 2020. The presentation is scheduled for November 17 at 10:00 am BT. A webcast of the event will be available for replay for 90 days. EDAP focuses on minimally invasive medical devices, including its Focal One® for prostate ablation and ExactVu™ Micro-Ultrasound. Potential risks include market acceptance of its HIFU devices and impacts from COVID-19 on demand.
EDAP TMS SA (Nasdaq: EDAP), a leader in therapeutic ultrasound, will release its third-quarter financial results for 2020 after market close on November 18, 2020. A conference call, led by CEO Marc Oczachowski and CFO François Dietsch, is scheduled for November 19, 2020, at 8:30 AM EDT. This event will allow investors and stakeholders to discuss the results and future outlook. EDAP TMS is recognized for its minimally invasive ultrasound medical devices, including the Focal One® and ExactVu™ systems for prostate treatment.
EDAP TMS SA (Nasdaq: EDAP) will host a Key Opinion Leader call on September 22, 2020, at 8am ET to discuss its commercial products, Focal One® and ExactVu™. The call features Dr. Brian Miles and Dr. Laurence Klotz, who will explore the potential of Focal One® High Intensity Focused Ultrasound (HIFU) and ExactVu™ micro-ultrasound. Management will also update on sales achievements and pipeline expansion opportunities beyond prostate cancer.
EDAP TMS SA (Nasdaq: EDAP) has announced its participation in the HC Wainwright Virtual 22nd Annual Global Investment Conference on September 15, 2020, at 10:30 AM EDT. A webcast of the presentation will be available for replay for 90 days. EDAP is a leader in the global therapeutic ultrasound market, focusing on minimally invasive medical devices for urology. The company has developed and marketed advanced robotic HIFU devices, including the Focal One®.
EDAP TMS SA (Nasdaq: EDAP) has initiated a Phase 2 clinical trial of its Focal One® High Intensity Focused Ultrasound (HIFU) for treating deep rectal endometriosis. The trial will involve 38 women at five major hospitals over a six-month follow-up period. The first two patients have already been treated, with more sessions scheduled. According to Pr. Gil Dubernard, the lead investigator, recruitment is proceeding swiftly, providing optimism for advancing this promising treatment. Endometriosis affects around 176 million women globally, and HIFU may offer a minimally invasive alternative to standard surgical options.
EDAP TMS SA reported its second quarter 2020 results, showing total revenue of EUR 9.3 million, down 26% year-over-year due to the COVID-19 pandemic. HIFU revenue fell 44.2% to EUR 2.6 million, while Lithotripsy and Distribution revenues also declined. Gross profit decreased to EUR 4.3 million, with a margin of 46.8%. Operating profit was EUR 0.3 million, contrasting with a profit of EUR 1.7 million in Q2 2019. The company holds a strong cash position of EUR 15.7 million. Future expectations are optimistic as procedure volumes are anticipated to normalize.
EDAP TMS SA has received approval to start a Phase II multicenter clinical trial for its Focal One® HIFU technology to treat deep rectal endometriosis in France, involving 38 patients across five hospitals. The trial is set to begin in September, led by Pr. Gil Dubernard. Initial Phase I results indicated promising outcomes. The company aims to expand its HIFU applications amid rising endometriosis prevalence, affecting approximately 176 million women globally. The initiative aligns with EDAP's strategic focus on enhancing its HIFU pipeline for high-value medical indications.
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