EDAP Announces Scientific Presentation Highlighting Feasibility of Focal One® to Perform Non-thermal Histotripsy Energy Delivery at the 187th Acoustical Society of America Meeting
EDAP TMS SA announced a scientific presentation demonstrating the technical feasibility of their Focal One® Robotic HIFU technology to perform non-thermal histotripsy energy delivery. The study, presented at the 187th Acoustical Society of America meeting, showed the system's capability to generate histotripsy lesions in biological tissues ex vivo. Histotripsy is a non-ionizing, non-thermal, and noninvasive technique for tissue ablation that uses microsecond ultrasound pulses for mechanical tissue destruction. The company views this as a significant technical milestone alongside their development of real-time elastography for ablation treatment confirmation.
EDAP TMS SA ha annunciato una presentazione scientifica che dimostra la fattibilità tecnica della loro tecnologia Focal One® Robotic HIFU per effettuare una somministrazione di energia a histotripsy non termica. Lo studio, presentato al 187° incontro della Acoustical Society of America, ha mostrato la capacità del sistema di generare lesioni da histotripsy nei tessuti biologici ex vivo. L'histotripsy è una tecnica non ionizzante, non termica e non invasiva per l'ablazione dei tessuti che utilizza impulsi ultrasonici di microsecondi per la distruzione meccanica dei tessuti. L'azienda considera questo un'importante pietra miliare tecnica, accanto allo sviluppo dell'elastografia in tempo reale per la conferma del trattamento di ablazione.
EDAP TMS SA anunció una presentación científica que demuestra la viabilidad técnica de su tecnología Focal One® Robotic HIFU para realizar la entrega de energía histotripsy no térmica. El estudio, presentado en la 187ª reunión de la Acoustical Society of America, mostró la capacidad del sistema para generar lesiones de histotripsy en tejidos biológicos ex vivo. La histotripsy es una técnica no ionizante, no térmica y no invasiva para la ablación de tejidos que utiliza pulsos de ultrasonido de microsegundos para la destrucción mecánica del tejido. La empresa considera esto un hito técnico significativo junto con el desarrollo de elastografía en tiempo real para la confirmación del tratamiento de ablación.
EDAP TMS SA는 Focal One® Robotic HIFU 기술의 비열적 히스토트립시 에너지 전달을 수행할 수 있는 기술적 가능성을 입증하는 과학적 발표를 발표했습니다. 187차 미국 음향 학회에서 발표된 이 연구는 시스템이 ex vivo 생물조직에서 히스토트립시 병변을 생성할 수 있는 능력을 보여주었습니다. 히스토트립시는 조직 절제를 위한 비이온화, 비열성 및 비침습적인 기술로, 미세 초음파 펄스를 사용하여 조직 파괴를 수행합니다. 이 회사는 이를 실시간 탄성영상화 개발과 함께 중요한 기술 이정표로 보고 있습니다.
EDAP TMS SA a annoncé une présentation scientifique démontrant la faisabilité technique de leur technologie Focal One® Robotic HIFU pour réaliser une délivrance d'énergie histotripsy non thermique. L'étude, présentée lors de la 187ème réunion de l'Acoustical Society of America, a montré la capacité du système à générer des lésions d'histotripsy dans des tissus biologiques ex vivo. L'histotripsie est une technique non ionisante, non thermique et non invasive d'ablation des tissus qui utilise des impulsions ultrasoniques de microsecondes pour la destruction mécanique des tissus. L'entreprise considère cela comme une étape technique importante, aux côtés de son développement de l'élastographie en temps réel pour la confirmation du traitement d'ablation.
EDAP TMS SA hat eine wissenschaftliche Präsentation angekündigt, die die technische Machbarkeit ihrer Focal One® Robotic HIFU Technologie zur Durchführung einer nicht-thermischen Histotripsie-Energieübertragung demonstriert. Die Studie, die auf dem 187. Treffen der Acoustical Society of America präsentiert wurde, zeigte die Fähigkeit des Systems, Histotripsie-Läsionen in biologischen Geweben ex vivo zu erzeugen. Histotripsie ist eine nicht ionisierende, nicht-thermische und nicht-invasive Technik zur Gewebeablation, die Mikrosekunden-Ultraschallpulse zur mechanischen Zerstörung des Gewebes verwendet. Das Unternehmen betrachtet dies als einen bedeutenden technischen Meilenstein neben der Entwicklung von Echtzeitelastographie zur Bestätigung von Ablationsbehandlungen.
- Technical advancement demonstrating new capabilities of Focal One® system
- Expansion into histotripsy technology shows potential for new treatment applications
- Progress in innovation roadmap strengthens market leadership position
- None.
Insights
The demonstration of histotripsy capabilities on the Focal One® system represents an incremental technical development rather than an immediate market impact. While this early feasibility study shows promise, it's important to note that this is just ex vivo testing - far from clinical implementation or revenue generation.
The expansion into histotripsy technology could eventually broaden EDAP's therapeutic applications beyond current thermal ablation methods, particularly in cancer treatment. However, significant clinical validation, regulatory approvals and commercialization efforts would be required before any meaningful financial impact materializes. This development, while scientifically interesting, is too early-stage to influence near-term business performance or stock valuation.
- Early feasibility work demonstrates Focal One system’s ability to generate histotripsy lesions ex vivo
LYON, France, November 22, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced a scientific presentation which demonstrated the technical feasibility of performing non-thermal histotripsy energy delivery and generating histotripsy lesions in biological tissues ex vivo using the Company’s Focal One® Robotic HIFU technology. The results from the study were presented on November 19th at the 187th Acoustical Society of America meeting, which is taking place virtually from November 18 - 22, 2024.
Histotripsy is a non-ionizing, non-thermal and noninvasive technique for tissue ablation that generates controlled acoustic microcavitation using microsecond ultrasound pulses leading to mechanical tissue destruction.1 Over the last several years, the technology has been increasingly evaluated for applications in cancer as well as benign conditions.
“The results from this initial technical feasibility study demonstrate EDAP’s continued commitment in driving innovation in our core focused ultrasound energy delivery technology,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “As focal therapy continues to evolve for the treatment of multiple conditions, histotripsy represents an expansion in energy-based therapies that we plan to further invest in and develop as part of our innovation roadmap. This technical milestone, in addition to our clinical development of real-time elastography to enable ablation treatment confirmation, demonstrates our commitment towards remaining the innovation leader in focal therapy.”
Presentation Details:
- Conference: 187th Meeting of Acoustical Society of America
- Oral Presentation: November 19, 2024, 5:00 PM ET
- Presentation Title: “Feasibility Study of Histotripsy with the Clinical Device Focal One®”
- Session: 1pBA, Bubble-Based Therapies
- Presenter: Virgil Accary, M.S.
1 Source: https://www.sciencedirect.com/topics/medicine-and-dentistry/histotripsy
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, us.hifu-prostate.com and www.focalone.com.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. 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 and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.
Other factors that may cause such a difference may also 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.
Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.
Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com
Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com
FAQ
What new capability did EDAP demonstrate for its Focal One® system in November 2024?
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What is histotripsy technology as mentioned in EDAP's presentation?
