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Theraclion SA

Regulatory Filings Oct 15, 2015

1701_iss_2015-10-15_e7363051-fcd4-42bb-8c39-2e9adbe01ebc.pdf

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Clinical study results demonstrate significant acceleration of Echopulse® treatment due to new BEAMOTION technology

Data shows BEAMOTION technology allows Echopulse treatment to be completed up to 5 times as fast as previously possible

Malakoff – FRANCE, October 15, 2015 – THERACLION (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, announces today that the new BEAMOTION procedure, designed to significantly speed up Echopulse treatment, exceeded expectations. The results on safety and tolerance of the treatment of the clinical study were presented today by Professor Roussanka Kovatcheva during the FUS Meeting, London, UK. Comparison with treatment duration data from the existing procedure indicate that BEAMOTION is up to 5 times faster than the previous technology.

Professor Kovatcheva presented the interim results of a clinical trial being conducted at the University of Sofia, Bulgaria. In this study, seven euthyroid patients with benign solitary or dominant thyroid nodule were treated with the Echopulse system using the new, moving beam BEAMOTION technology.

Professor Kovatcheva reports that the moving-beam technology BEAMOTION was safe and was welltolerated by patients.

Whereas the previous technology applied a fixed beam to deliver the HIFU (high intensity focused ultrasound) beam, the BEAMOTION technology moves the treatment head during beam delivery, covering a larger single beam treatment area. Therefore, the total number of treatment areas is reduced seven-fold and treatment time is significantly reduced. When compared to previously reported treatment duration data, the overall treatment time (first to last beam) was reduced by up to 5 times. Whereas the previous mean treatment duration was 83min, treatments realized in the new trial were as short as 17 minutes.

The BEAMOTION technology is CE-mark pending and is targeted to be commercially available and in regular clinical use before the end of the year.

"We are extremely proud to announce this number: a treatment time reduction by up to 3 is what we hoped for. To see a five-fold reduction in a clinical trial is incredible and very important for the future development of Theraclion," said David Caumartin, CEO of Theraclion. "Rapid treatment is one of the main factors driving clinical adoption. Treating faster facilitates treating bigger nodules and therefore accessing a completely different patient population. This improves the business model for our customers."

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 30 people, 53 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 [email protected] [email protected]

Kalima

Press Relations Estelle Reine-Adélaïde/ Florence Calba Tel. : + 33 (0)1 44 90 82 54 [email protected]

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

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