Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE) (Paris:ALTHE), an innovative company developing a robotic platform for non-invasive ultrasound therapy, has achieved major milestones in its development strategy in the first half of the year.

R&D at the core of the new strategy

Yann Duchesne, Executive Chairman of Theraclion since January 2022, is executing a new strategy. He is focusing Theraclion on improving technology performance and clinical benefits to access vein markets in the US. In Europe, the focus is on standardizing treatment protocols among current Key Opinion Leaders (KOLs) to pave the way for aggressive growth and U.S. clinical trials. Theraclion will resume its commercial efforts upon finalization of treatment protocols.

Yann Duchesne's vision is to develop Theraclion in three therapeutic areas and three geographies: varicose veins, in the U.S. (FDA application pending) and in Europe; thyroid, in Europe and China; and breast cancer, primarily in the U.S. Value creation consists of proving the potential of our disruptive technology through robust clinical trials in each of our three indications and geographies. Theraclion is advancing on concluding strategic partnerships by indication/geography: e.g. Veins USA, Thyroid China, Breast USA, Veins China, Thyroid USA... Such partnerships will highlight our technology and show its true value. Negotiations are underway.

First treatments in the U.S. in a feasibility trial as a prelude to the pivotal registration study with the FDA

The first patients were treated with SONOVEIN® in the United States at the Englewood center, New Jersey by vascular surgeons Dr. Steven Elias, Dr. Antonios Gasparis and Prof. Nicos Labropoulos in a feasibility trial. This is a major milestone in obtaining marketing authorization from the Food and Drug Administration (FDA).

These first treatments represent a further step in the strategy of focusing on key varicose vein markets, of which the United States is the largest with $5 billion in annual spending.

SONOVEIN® HD: first treatments with a standard system

This first half of 2022 is marked by the acceleration of technical developments, resulting in the release of the first SONOVEIN® HD to opinion leaders. This new version integrates the SuperSonic Imagine (Hologic) Mach30 imager.

The SONOVEIN® HD has been very well received by surgeons and vascular physicians and they are working on the optimization of treatment protocols.

Inclusion of the first patients in Phase IIA breast cancer research

The first patients were included in the Phase IIA of this partnership with the University of Virginia Cancer Centre (UVA) in the United States. Breast cancer research takes another step forward.

The study aims to establish the combined effect of high intensity focused ultrasound (HIFU) and low dose chemotherapy on the immune response to breast cancer. After a first phase on advanced stage subjects, this second part concerns early stage subjects.

Results as of June 30th, 2022

A capital increase of 6.5 million euros was successfully carried out in February and strengthened financial visibility. A move to new premises, also in Malakoff (Paris), in June, increases the space dedicated to R&D.

Theraclion SA had revenues of €347K in the first half of 2022, a decrease of 61% compared to the first half of 2021. Theraclion sold 4 Echopulse® systems in 2021 compared to only one refurbished system sold in 2022. Sales of consumables increased by 45%, driven by sales of consumables for the treatment of varicose veins. The expert centers have a mixed activity of developing treatment protocols and commercial treatments.

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About Theraclion

At Theraclion, we believe that surgery as we know it is outdated. It generates excessive anxiety in patients and turns doctors into the executors of an archaic system. On the other hand, it subjects the health care system to tensions that are difficult to sustain. We therefore wanted to shake up this convention by creating an extracorporeal treatment device. Our solution replaces surgery with a robotic treatment that directs high-intensity focused ultrasound (HIFU) from outside the body. Our state-of-the-art ultrasound therapy device has already obtained CE mark for the non-invasive treatment of varicose veins with SONOVEIN® and breast fibroadenomas and thyroid nodules with Echopulse®.

Based in Malakoff, near Paris, our employees are constantly seeking innovation, combining high-level clinical research with the benefits of artificial intelligence. The varicose vein treatment market alone generates approximately 5 million procedures per year. It is therefore a dynamic market in which we are changing the paradigms by making non-invasive ultrasound therapy the new standard.

For more information, please visit and our patient platform

Theraclion is listed on Euronext Growth Paris

Eligible for the PEA-PME scheme

Mnémonique : ALTHE - Code ISIN : FR0010120402

LEI : 9695007X7HA7A1GCYD29


David AUREGAN Chief Operating Officer

Anja KLEBER VP Marketing, Market Access & Sales Francophonia

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