Theraclion SA

Regulatory Filings • Nov 15, 2017

Theraclion and Lead Investigator Presented Preliminary Results of Echotherapy In the Treatment of Varicose Veins

These results concern the first study worldwide on the treatment with High Intensity Focused Ultrasound of insufficient superficial and perforating veins of the lower limb.

Malakoff - FRANCE, November 15, 2017 - THERACLION (Euronext Growth, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, and lead investigator Alfred Obermayer, M.D., vascular surgeon at the St. Joseph Hospital in Vienna, director of the Karl Landsteiner Institute for Functional Phlebology – Melk, Austria presented the preliminary results of the first clinical trial on Theraclion's Echotherapy (also known as High Intensity Focused Ultrasound, HIFU) in the treatment of insufficient superficial and perforating veins of the lower limb. Dr. Obermayer presented that:

• The trial will enroll 35 patients and will be followed-up for 3 months after the procedure. The aim of the trial is to assess feasibility, blood reflux abolition, ease of use, patient preference, tolerability and safety of echotherapy.
• For all the patients treated in the study, the procedure was feasible, and no procedures were interrupted or cancelled due to technical or medical reasons related to the treatment.
• Most of the cases were severe Chronic Vein Disease patients with long history of treatments (surgery and thermal endovenous included), presenting active or healed ulcers, severe skin disorders, significant vein disease related symptoms, mostly over 50 yo and with a high BMI.
• Contrary to other thermal methods, which are endovenous, no analgesia was provided to the patients neither before, during nor after the treatments.
• No significant side effects were reported during the treatment and the follow-up period (no skin burns, skin changes, ecchymosis, erythema or edema were present during and after the procedure).
• All the patients were satisfied with the procedure.

Several examples of successful treatments were presented including incompetent anterior accessory saphenous veins, stumps (recurrences at the groin) and perforator veins, showing no blood reflux after echotherapy treatment.

"The preliminary results are very promising with a lack of significant adverse events" said David Caumartin, Chief Executive Officer of Theraclion. "Our hope is to offer a non-invasive new option for the growing number of patients suffering from chronic veins disease (CVD). Many of these patients, especially in recurrent disease or presence of active ulcer, do not respond well to existing surgical or endovenous treatments."

A replay of the webcast is available on the Theraclion website at www.theraclion.com.

Alfred Obermayer, M.D., is surgeon in chief at the St. Joseph Hospital in Vienna – Austria and director of the Karl Landsteiner Institute for Functional Phlebology – Melk, Austria. His clinical practice specializes in the treatment of venous pathology. Dr. Obermayer is a trained surgeon and since more than 15 years is an expert on surgical procedures involving thermal procedures - radiofrequency, LASER, steam, as well as foam sclerotherapy and various leg ulcer treatments. His primary research interests include focused ultrasound treatment of superficial and perforator veins, and sourcing of venous insufficiency. He has published as main author in Journal of Vascular Surgery, European Journal of Endovascular Surgery and is among the experts defining the consensus guidelines for the Society for Vascular Surgery and the American Venous Forum.

About Theraclion

Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound. Drawing on leading-edge technologies, Theraclion has designed and manufactured an innovative solution for echotherapy, the Echopulse®, allowing non-invasive tumor treatment through ultrasound-guided high-intensity focused ultrasound. Theraclion is ISO 13485 certified and has received the CE mark for non-invasive ablation of breast fibroadenomas and thyroid nodules. Based in Malakoff, near Paris, France Theraclion has brought together a team of 35 people, 50% of whom are dedicated to R&D and clinical trials. For more information, please visit Theraclion's website: www.theraclion.com

Theraclion is listed on Euronext Growth Paris PEA-PME eligible Mnemonic: ALTHE - ISIN Code: FR0010120402

Contacts :

Theraclion Kalima David Caumartin Relations Presse Directeur Général Sarah Hachemi Tel.: +33 (0)1 55 48 90 70 Tel.: + 33 (0)1 42 21 56 36 david.caumartin@theraclion.com shachemi@kalima-rp.fr