MALAKOFF, France--(BUSINESS WIRE)--Regulatory News:
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a scalable robotic platform for non-invasive ultrasound therapy to treat varicose vein disease, announced at the 2022 AVLS congress in New Orleans, Louisiana (US), on October 14th, that the final patient enrolled in the first SONOVEIN® study in the United States has been treated.
Finalized enrollment in the US study on echotherapy for varicose veins
In total, 20 patients were enrolled in this clinical trial approved by the FDA (Food & Drug Administration) in early 2022. Conducting the clinical trial are Dr Steve Elias, principal investigator, Dr Nicos Labropoulos, and Dr Antonios Gasparis, all three internationally recognized vein specialists with more than 30 years of experience each.
SONOVEIN® HD utilizes a robotic platform that integrates the best-in-class, high-definition MACH30 10-12Mhz ultrasound imaging system with high intensity focused ultrasound to obliterate the source of venous reflux completely non-invasively.
Encouraging early results presented at the 2022 AVLS congress
Early results were presented at the 36th American Vein & Lymphatic Society (AVLS) Annual Congress in New Orleans, Louisiana, on October 14th. Dr Elias highlighted that 19/20 (95%) of cases had no reflux at one week interval. The completion of the study was three months interval, 10 out of 10 had no reflux. There were no reported adverse events. All patients were treated without local or tumescent anesthesia. No post procedure compression was utilized.
Dr Elias shared during the congress that SONOVEIN® HD enabled faster treatment than previous generations and that he ‘only needed his pencil and his ultrasound gel’ to treat his patients. He also stated that all treated patients would recommend it to others: ‘this highlights that patients can be treated sitting in an exam chair and return to normal activity immediately’.
Dr Michel Nuta, Chief Medical Officer at Theraclion, said: ‘a 95% success rate, taking the learning curve into account, is very encouraging and reflects well the great clinical and technical developments behind SONOVEIN® HD’.
Next on the agenda: this study’s closure, and the start of a full pivotal study
The US is the largest market for varicose veins with an estimated 2.3 million procedures representing a $5 Billion healthcare spending. Following the upcoming closure of this clinical trial, a full pivotal study for FDA review should take place next.
At Theraclion we believe that surgery, as we know it, is outdated. It converts optimistic patients into anxious individuals, brilliant doctors into exhausted system executors and stretches healthcare systems to the limit. We have disrupted this convention by creating extracorporeal treatment platforms. We replace surgery with a robotic treatment from outside the body using High Intensity Focused Ultrasound (HIFU). Our leading edge echotherapy platforms are currently CE marked in non-invasive treatment of varicose veins with SONOVEIN® and of breast fibroadenomas and thyroid nodules with Echopulse®.
Located in Malakoff, near Paris, our employees live and breathe innovation by extensive clinical research and harness artificial intelligence. The market of varicose veins treatment alone requires around 5 million procedures annually. It is a dynamic market in which we change paradigms by making non-invasive echotherapy the new standard.
Theraclion is listed on Euronext Growth Paris
Eligible for the PEA-PME scheme
Mnemonic: ALTHE - ISIN code: FR0010120402