Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a scalable robotic platform for non-invasive echotherapy, announces today the treatment of varicose veins patients with SONOVEIN for the first time in the United States (US).

The study has been approved by the FDA (Food and Drug Administration) a few months ago. Since then, Theraclion has installed its state-of-the-art SONOVEIN platform and trained physicians. The first patients have been treated by Dr Steven Elias, Dr Nicos Labropoulos and Dr Antonios Gasparis, all three internationally recognized vein specialists with more than 30 years of experience.

“After this clinical trial, a full pivotal study will be conducted for FDA review in view of the market authorisation. Our qualitative pre-clinical studies, the CE marking since 2019 and our clinical data from our European centers should support a fast approval for our pivotal study” said Michel Nuta, MD, Chief Medical Officer, Vice President Veins at Theraclion SA.

This trial is in line with Theraclion’s strategy to focus on key markets. The US is the largest market for varicose veins with an estimated 2.3 million procedures representing a $5 Billion healthcare spending.

SONOVEIN is the only non-invasive option for varicose veins. It does not require incisions, leaves no scars and allows patients an immediate return to daily activities. This advanced technological solution unleashes new treatment opportunities and improves both patient’s and physician’s experiences.

About Theraclion

At Theraclion we believe that surgery, as we know it, is outdated.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 Focussed 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.

For more information Please visit www.theraclion.com and our patient website www.echotherapy.com

Theraclion is listed on Euronext Growth Paris Eligible for the PEA-PME scheme Mnemonic: ALTHE - ISIN code: FR0010120402 LEI: 9695007X7HA7A1GCYD29

Theraclion

David Auregan Chief Operating Officer david.auregan@theraclion.com

Anja Kleber VP Marketing, Market Access & Sales Francophonia anja.kleber@theraclion.com

Theraclion (EU:ALTHE)
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