Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE) (Paris:ALTHE), an innovative company developing a robotic platform for non-invasive ultrasound therapy, announces that it has signed a commercial partnership with the University of Virginia (UVA), in the United States, for the use of Theraclion's latest technology in a new experimental breast cancer treatment. This pilot study, which has received FDA (Food & Drug Administration) approval, will evaluate the combined effect of high intensity focused ultrasound (HIFU) and low dose chemotherapy on the immune response to breast cancer. The aim is to add HIFU into routine breast cancer treatment.

Theraclion's valuable technology in breast cancer treatment

The HD technology has shown excellent clinical results in vein treatment. Its visualization capabilities and its very high control of acoustic energy deposition open up new prospects in the use of High Intensity Focused Ultrasound (HIFU) in breast cancer treatment.

Building on a successful initial partnership in advanced breast cancer patients, the University of Virginia (UVA) Cancer Center has purchased Theraclion's latest HD technology to launch a pilot study for early breast cancer.

This protocol will evaluate the combined effect of Theraclion's focused ultrasound and low-dose chemotherapy in patients with early breast cancer. The 48-patient randomised trial will assess 3 arms: HIFU combined with chemotherapy, chemotherapy on its own and HIFU on its own.

If the combination of HIFU and chemotherapy decreases myeloid-derived suppressor cells and thus increases the patient's immune response, this combination treatment could offer early breast cancer patients a better chance of survival.

Prof. David Brenin, Chief of the Division of Breast and Melanoma Surgical Services at UVA Health, stated that: “By causing acute thermal cell damage that triggers a local immune response, we hypothesize that HIFU, in combination with chemotherapy, could decrease the circulation of cancer cells and increase the activity of suppressor cells. HIFU could then be used prior to surgery, potentiating the effect of chemotherapy with the goal of preventing the expansion of the cancer and its recurrence.”

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At Theraclion we believe that surgery, as we know it, is outdated.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

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 contact David AUREGAN Chief Operating Officer david.auregan@theraclion.com

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