Theraclion SA

Regulatory Filings • Jun 8, 2016

New clinical study results reinforce echotherapy efficacy in breast fibroadenoma

Complete destruction of nodules in 90% of patients demonstrated by first "treat and biopsy" study results

Malakoff – June 8, 2016 – THERACLION (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, announced today that Tübingen University has presented promising Echotherapy results from its breast fibroadenoma (BFA) trial. 90% of BFA patients treated with Echotherapy presented at 12 months post-treatment with no vital fibroadenoma tissue.

In the study, 27 patients were treated utilizing Theraclion's therapeutic ultrasound technology to evaluate the safety and efficacy of the technique. The center's initial experience was reported in a peerreviewed article published in the "Senologie Journal". Now the preliminary histology results were reported by Professor Markus Hahn's team during the German Congress of Senology in Dresden that took place on May 26—28th, 2016.

At 12 months post-procedure, biopsies were performed and preliminary results show that:

• 24/27 of the biopsied patients were without residual vital BFA tissue.
• 26 out of 27 patients declared that they would recommend the procedure.

"These results are extremely encouraging," explains Michel Nuta, Chief Medical Officer of Theraclion. "Echotherapy has initially been designed for volume reduction of a nodule, not for its complete destruction. These preliminary results show that there is reason to believe that by adapting the protocol, complete tissue destruction can be obtained."

Pr. Markus Hahn, senior author within the Tubingen group, adds: "Histology performed 12 months after treatment was able to show absence of vital tissue in 90% of cases. The technique which is very easy to use could be envisioned for breast cancer treatment in the short-term future."

"These results exceed our expectations by far. While for BFA the treatment objective remains volume reduction, complete tissue destruction with a completely non-invasive method without radiation could become a promising option for breast cancer patients in the future", adds David Caumartin, CEO of Theraclion.

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 34 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 Alternext Paris PEA-PME eligible Mnemonic: ALTHE - ISIN Code: FR0010120402

Contact:

Theraclion NewCap

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

Kalima

Press Relations Estelle Reine-Adélaïde / Florence Calba Tel.: + 33 (0)1 44 90 82 54 era@kalima-rp.fr

David Caumartin Financial Communication and Relations Chief Executive Officer Emmanuel Huynh / Valentine Brouchot