Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a scalable robotic platform for non-invasive echotherapy, announces today the first patient treatment in an early-stage breast cancer study in collaboration with the University of Virginia Cancer Center, USA. The trial seeks to investigate the combination of High Intensity Focused Ultrasound (HIFU) and low-dose chemotherapy to augment immune control of breast cancer.

Early-stage breast cancer focus following promising results of initial study

Registered on ClinicalTrials.gov, the new study was designed by Pr. David Brenin and Pr. Patrick Dillon. The research aims to evaluate the conjunctive effect of Theraclion’s focused ultrasound and low-dose gemcitabine in early-stage breast cancer patients. ’We will examine whether the dual therapy decreases myeloid-derived suppressor cells and thus increases the immune response,’ explains David Brenin, Chief of the Division of Breast and Melanoma Surgical Services and Professor in the Department of Surgery at UVA Health. ‘If demonstrated to be effective, the combined treatment could provide patients with early-stage breast cancer an improved chance of survival,’ adds Patrick Dillon, Associate Professor in the Department of Hematology and Oncology at UVA Health.

After an initial successful collaboration on late-stage breast cancer patients, the University of Virginia (UVA) Cancer Center has extended the use of Theraclion’s world-class technology to a phase-2 investigation in early-stage breast cancer. These two studies emphasize the need for a mixed approach, combining the non-invasive HIFU, data-driven platform with the pharmacological options, either chemotherapy or immune-oncology molecules, to offer alternative treatments for early- and late-stage breast cancer.

Every year, 2.3 million women are diagnosed with breast cancer and the disease is responsible for 685,000 deaths globally. Moreover, 7.8 million women alive had been diagnosed with breast cancer over the past 5 years as of 2021, making it the world’s most prevalent cancer.1 An estimated 3.8 million women have a history of breast cancer in the US2. ‘We are excited about this opportunity to explore, together with the University of Virginia, our technology’s full potential for improving patients’ lives’, says David Caumartin.

Theraclion’s strategic development in 3 major therapeutic areas in 3 geographies

Theraclion’s growth strategy involves expanding 3 major therapeutic areas in 3 geographic areas:

  • Varicose veins, in the USA (seeking FDA clearance) and in Europe
  • Thyroid, in Europe and in China
  • Breast cancer, mostly in the USA

To achieve these ambitious goals, Theraclion will secure financing and strategic partnerships and mainly focus on key technical and clinical milestones.

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 Mnemonic: ALTHE - ISIN code: FR0010120402 LEI: 9695007X7HA7A1GCYD29

1 https://www.who.int/news-room/fact-sheets/detail/breast-cancer 2 Howlader N, Noone AM, Krapcho M, et al., eds. SEER Cancer Statistics Review, 1975-2016. Bethesda, MD: National Cancer Institute; 2019. Available from seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site April 2019

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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