Theraclion SA

Regulatory Filings • Aug 31, 2015

Theraclion announces first European commercial agreements of Echopulse® for the treatment of thyroid nodules

• Two German centers join the Hong Kong University, Queen Mary Hospital, in offering thyroid treatments to their patients
• Further clinical data confirms the mid-term efficiency of Echopulse in thyroid nodules

Malakoff – August 31th, 2015 – THERACLION (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, announces today the first two commercial agreements for thyroid nodules in Europe: Drs. Hakman – Praxis für Nuklearmedizin, Paderborn, a prestigious private nuclear medicine practice, and BORAD, Bottrop, a private practice group for radiology, nuclear medicine and radiotherapy, will be offering Echopulse system treatments for benign thyroid nodules to their patients. The latter purchased the thyroid software option and will be offering the treatments on the already operational Echopulse system at the Marienhospital, Bottrop. Both practices as well as the Queen Mary Hospital plan to start treatments in the coming weeks.

The market for thyroid surgeries worldwide is estimated at over 1 million procedures per year. Germany alone, a traditionally iodine lacking region, represents approximately 100,000 surgeries and 50,000 radioiodine procedures annually. Many of these procedures could be replaced by a non-invasive approach using the Echopulse system, eliminating general anesthesia, hospitalization and scarring. Thyroidectomies very often result in the need for life-long medication. The treatment with Echopulse offers a non-invasive, local procedure, preserving the natural function of the thyroid. In addition to the clinical benefits for the patient, Echopulse offers an economically appealing option to healthcare systems, as the outpatient procedure requires no surgical suite, nor the intensive human resources typically associated with surgery.

Theraclion also announces the publication of results on the mid-term assessment of nodular volume reduction of benign thyroid nodules treated by Echopulse. The article, published in the journal Röfo and entitled "Localized thyroid tissue ablation by High Intensity Focused Ultrasound: Volume reduction, effects on thyroid function and immune response", is available online at: http://www.ncbi.nlm.nih.gov/pubmed/26200565.

The study included 12 patients with one thyroid nodule each. The patients were examined three months after the procedure and assessed by nodular volume measurements both before the treatment performed by Echopulse and after the end of the follow-up period. The study was performed and assessed by Huedayi Korkusuz, MD, Associate Professor, member of the team of Professor Grünwald (Nuclear Medicine Department, Goethe University Clinic, Frankfurt a. M., Germany).

The article published in the journal affiliated to the German and Austrian Roentgen societies, demonstrates that the consistent Echopulse postoperative results are confirmed at mid-term by the nodular volume assessment. The patients treated with Echopulse showed:

• a significant reduction of 55% (median) in thyroid nodule volume three months after the procedure (p<0.05),
• a single treatment session is sufficient to reach these results,
• complete preservation of thyroid function, all patients being euthyroid throughout the assessment,
• the total absence of induced autoimmune diseases or thyrotoxicity.

Additionally, no serious side effects related to the procedure were reported after three months of followup, in line with the previous observations.

"Germany is a strategic market for us, in particular for thyroid nodules. The practices in Paderborn and Bottrop are now the first in Europe providing patients access to the treatment on a routine clinical practice base," declares David Caumartin, CEO of Theraclion. "This is significant news for all patients suffering from palpable benign thyroid nodules in Germany. We will continue efforts to develop patient access to this noninvasive treatment for thyroid nodules in cooperation with our partner GVN (Gesundheitsverbund Nord) via integrated care contracts. The Echopulse system offers better, non-invasive care, as has been shown once more by the latest publication of the University of Frankfort, and comes at a lower cost to the healthcare system. We are confident that this is just the beginning for Echopulse."

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 25 people, 52 percent 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

Contacts:

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

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

David Caumartin Financial Communications & Investors relations CEO Emmanuel Huynh / Valentine Brouchot