Theraclion SA

Regulatory Filings • Oct 2, 2014

THERACLION presents positive results from a study published in the "Journal of Therapeutic Ultrasound"

This study showed the safety and the feasibility of the scintigraphic assessment of Echopulse® in the treatment of benign thyroid nodules:

• Post operatively assessable by scintigraphic means procedure
• Safe and adverse event free procedure
• Easy to perform technique

Malakoff - FRANCE, October 2nd, 2014 - THERACLION (Alternext, FR0010120402 - ALTHE, PEA PME eligible), a company specialized in cutting-edge medical equipment for echotherapy, announces today the results published on September 30, 2014 in the « Journal of Therapeutic Ultrasound » on the early assessment of benign thyroid nodules treatment by Echopulse®, using scintigraphic ¹ measures entitled: Early assessment of high-intensity focused ultrasound treatment of benign thyroid nodules by scintigraphic means is available online: http://www.jtultrasound.com/content/2/1/18

This series of cases – hot and cold benign thyroid nodules – was performed over four consecutive days and assessed by Korkusuz Huedayi, MD (Nuclear Medicine Department, Goethe University Clinic, Frankfurt am Main, Germany).

Ten patients, examined acutely after the procedure, were assessed by scintigraphy before and after the treatment performed by Echopulse®.

The article published in the US journal demonstrates that the excellent Echopulse® postoperative results are confirmed by a scintigraphic assessment. The patients treated with Echopulse® showed:

• a relative nodular uptake in relation to total thyroidal uptake decreased in all cases, showing immediate induced ablation.
• a median 99mTc-MIBI uptake reduction of 35.5% (ranging from 11% to 57% ; p<0.1).
• a median 99mTc-Pertechnetate uptake reduction of 27% (ranging from 10% to 24% ; p<0.1).
• an easy to perform ambulatory procedure, completed out of the OR.

In terms of safety, no serious side effect related to the procedure was reported and no re treatment was necessary.

Huedayi Korkusuz MD, principal investigator, comments: "The treatments performed in our nuclear medicine department with the ultrasound guided HIFU Theraclion system over just a couple of days are showing that scintigraphic assessment of the procedure is feasible, adding a new tool for the objective measurements of the procedure impact. The treatments are easy to perform and very well

¹ A diagnostic test in which a two-dimensional picture of a body radiation source is obtained through the use of radioisotopes.

tolerated by the patients, under minimal anesthesia – local or simple sedation, in a procedure room environment. All patients were able to leave the facility the same day, no hospitalization was necessary."

Michel Nuta MD, Theraclion Chief Medical Officer, concludes: "On the basis of these good results, we are pursuing our optimization program for the treatment duration reduction, the coverage of the targeted tissues and the long term assessment procedure benefits."

About Theraclion

Based in Malakoff, near Paris, Theraclion is a French company specialized in cutting-edge medical devices for echotherapy. Theraclion designs, develops and markets a medical device (Echopulse®) that combines advanced ultrasound imaging and HIFU therapy. Theraclion is ISO 13485 certified and has received the CE mark for noninvasive ablation of breast fibroadenomas and thyroid nodules. A full 70% of its 19-strong team are dedicated to R&D and clinical trials. For more information, visit http://www.theraclion.com.

Theraclion is listed on Alternext Paris PEA-PME Eligible Mnemonic: ALTHE - ISIN Code: FR0010120402

Contacts:

Theraclion NewCap. Tel.: +33 (0)1 55 48 90 70 Tel.: +33 (0)1 44 71 94 91 david.caumartin@theraclion.com theraclion@newcap.fr

ALIZE RP Press Relations Caroline Carmagnol / Valentine Boivin Tel.: + 33 (0)1 70 22 53 92 theraclion@alizerp.com

David Caumartin Financial Communications & Investors relations CEO Emmanuel Huynh / Sophie Boulila