Theraclion SA

Regulatory Filings • Oct 21, 2020

Positive and differentiated results for Theraclion's non-invasive varicose vein treatment technology revealed at the 34th AVLS

Malakoff, October 21, 2020 - THERACLION (ISIN: FR0010120402; Mnemo: ALTHE, PEA-PME eligible), an innovative company specialized in echotherapy treatment (using High Intensity Focused Ultrasound or HIFU), announces highly positive results for its non-invasive echotherapy solution, SONOVEIN.

Professor Dr. Mark Whiteley presented his results during the 34th annual congress of the American Vein & Lymphatic Society (AVLS). AVLS is the premier and largest association for physicians dedicated to treatment of venous disease. Prof. Mark Whiteley is a renowned UK Venous Surgeon and Consultant Phlebologist, and founder of The Whiteley Clinic.

Prof. Whiteley was the first to adopt SONOVEIN in clinical routine. He presented his "6 months outcomes from High Intensity Focused Ultrasound closure of incompetent saphenous and perforator veins" at AVLS. Details on 6 months follow-up on 22 patients was presented.

• 94.5% of the patients suffered from varicose veins (C1 to C4 stages of the CEAP classification¹ )
• 45 veins were treated including Great Saphenous Veins, Small Saphenous Veins, Anterior Accessory Saphenous Veins and Perforator Veins
• 100% closure rate was achieved immediately after SONOVEIN echotherapy on truncal veins
• Successful ablation of 82% after 2 months and 6 months of perforator veins, which often do not have a satisfying treatment option with current standards.
• the mean age was 55,5 years and the ratio male to female was 36% to 64%

"SONOVEIN, a high precision echotherapy solution, represents the most progressive technology in the world for treating varicose veins and venous leg ulcers. Unlike endovenous laser, radiofrequency and even foam, this treatment is 100% non-invasive. There is no other technique that is non-invasive and can treat the vein from outside the body" explains Professor Whiteley.

SONOVEIN S, Theraclion's second generation technology, was revealed just earlier this month.

SONOVEIN S – first patients already treated at the Whiteley Clinics, London

Prof. Whiteley also presented his feedback on the second generation technology of SONOVEIN during AVLS. "SONOVEIN S is a game changer. It really does not need any form of anaesthesia. This accelerates the treatment and identification of the vein is very much easier than with existing methods."

Chronic Venous Insufficiency (CVI) and venous ulceration is a common health problem causing significant patient morbidity. Apart from the chronic physical and psychological disability caused to the individual, it also results in an enormous economic burden to the health care administration. Global prevalence rates of CVI are variable but may be as high as 40% among

¹ https://thewhiteleyclinic.co.uk/self-assessment/ceap-classification/

females and 17% among males² . Venous pathology generates around 5 million treatment procedures per year ³ .

About Theraclion

Theraclion has developed an innovative high-tech echotherapy solution using High Intensity Focused Ultrasound for the treatment of varicose veins, SONOVEIN®. The treatment solution, which obtained CE marking in April 2019, is based on the leading-edge echotherapy treatment expertise developed over years by Theraclion for non-invasive ablation of breast fibroadenomas and thyroid nodules using its ECHOPULSE® solution. Further improvements to the ECHOPULSE technology are the foundation for SONOVEIN to provide the only non-invasive ablation therapy for varicose veins. This procedure allows for a treatment without a catheter, chemical injection, or incision. An operating room is not necessary, and the treatment can be performed at a doctor's offices or in clinics, as well as in hospitals. Venous pathology is widespread worldwide and generates around 5 million treatment procedures per year, according to Millennium research Varicose Vein Device Market Study 2015. Theraclion's technological solutions are based on high-tech ultrasound medical imaging devices that are precise and easy to use for practitioners.

Located in Malakoff, near Paris, Theraclion brings together a team of 25 people, more than half of whom are dedicated to R&D and clinical trials.

For more information, please visit the Theraclion website: www.theraclion.com and the patient site: https://echotherapie.com/echotherapy/

Theraclion is listed on Euronext Growth Paris

Eligible for the PEA-PME scheme

Mnemonic: ALTHE - ISIN code: FR0010120402

LEI: 9695007X7HA7A1GCYD29

Contacts Theraclion

David Caumartin Chief Executive Officer Tél : + 33 (0)1 55 48 90 70 david.caumartin@theraclion.com Anja Kleber VP Marketing, Market Access & Sales Francophonia anja.kleber@theraclion.com

² https://www.peertechz.com/articles/IJVSM-5-132.php

³ Millenium research Varicose Vein Device Market Study 2015