Regulatory News:
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE innovative company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy, announces that its cutting-edge technology to treat varicose veins has recently been showcased at a number of prestigious medical conferences and in a new scientific journal:
- Prof. Paolo Casoni and his team have achieved a 98% success rate with SONOVEIN®.
- This result compares with other SONOVEIN studies, notably the US feasibility study's 95% success rate, and with traditional treatments' results, but being noninvasive lowers complication risks.
- 5 Key Opinion Leaders presented on SONOVEIN at international conferences in the past month.
A new scientific publication on SONOVEIN® finds a 98.3% efficacy after 12 months
Prof. Paolo Casoni and his team conducted a 12-month study on the effect of High Intensity Focused Ultrasound on great saphenous vein (GSV) incompetence using SONOVEIN. Among the 188 limbs treated, the treated GSV segment showed a success rate of 98.3% at 12 months. The study was published in April in Phlebology, The Journal of Venous Disease, one of the most best-known peer-reviewed medical journal covering research on vascular diseases.
From New York to Venice, Key Opinion Leaders presented their results with SONOVEIN®
In the United States: Steve Elias, MD, one of main investigators of the Sonovein US feasibility study that ended in early 2023, presented his final results at the Venous Symposium: 100% feasibility result and 95% efficacy endpoint met. The event took place in central New York from May 8 to 11. It was attended by more than 600 people, mostly vascular surgeons, from 40 countries, predominantly the United States. An enthusiastic interest in the technology was forcefully communicated to the Theraclion team.
Steve Elias MD is also the main investigator in the Sonovein pivotal trial currently underway and with a view to receive FDA's (Food Drug Administration) approval by 2026.
In the United Kingdom: The College of Phlebology held a special event in Guildford on May 3 and 4, in which the Sonovein was introduced to a group of carefully selected vascular surgeons from all over the world. 35 attendees had the opportunity to witness a live case of Sonovein treatment on a patient, along with presentations from early adopters Luis Izquierdo Lamoca, MD, from Madrid, Spain, Guillaume Stalnikiewicz, MD, from Lille, France, and Prof. Mark Whiteley, from the UK. A successful event that generated significant excitement among potential new Sonovein users.
In Italy: At the Vein in Venice International Symposium held from April 18 to 20, Sonovein early users Guillaume Stalnikiewicz MD from Lille, France, and Ruben Rodriguez Carvajal MD from Marbella, Spain, presented their work with Sonovein to a couple of hundred attendees in Mestre (Venice), Italy. They presented state-of-the-art clinical outcomes on several hundred Sonovein-treated patients. Sparking attendees' interest in the groundbreaking nature of the technology, both KOLs were asked numerous questions about Sonovein. The Theraclion team was present and addressed a number of business requests.
Italian users Prof. Paolo Casoni and Emmanuele Nanni MD recently presented their work with Sonovein at 4 different congresses: in Bologna (February 23-24) at the Society of Aesthetic Medicine congress, in Perugia (April 12) at the Italian Society of Phlebology and in Parma at the Chiesi Farmaceutici Phlebological Meeting (April 13). Emmanuele Nanni MD spoke at the Canadian Society of Phlebology in Montreal on May 3. On June 27-29, Matteo Pizzamiglio MD and Prof. Paolo Casoni will present their latest scientific publication at the European Venous Forum in Athens.
About Theraclion
Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound.
High Intensity Focused Ultrasound (HIFU) does not require incisions nor an operating room, leaves no scars, and allows patients an immediate return to their daily activities. The HIFU treatment method concentrates therapeutic ultrasounds to an internal focal point from outside of the body.
Theraclion develops the HIFU, CE-marked, platform for varicose veins treatment SONOVEIN®, having the potential to replace millions of surgical procedures every year.
Based in Malakoff (Paris), the Theraclion team is made up of about 30 people, mainly in technological and clinical development.
For more information, please visit www.theraclion.com and follow the account on LinkedIn
Theraclion is listed on Euronext Growth Paris
Eligible for the PEA-PME scheme
Mnemonic: ALTHE ISIN code: FR0010120402
LEI: 9695007X7HA7A1GCYD29
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Contacts:
Theraclion contact
Martin Deterre
Chief Executive Officer
contact@theraclion.com
