Initial Feedback Received from France's National Health Authority HAS in Relation to Theraclion’s Forfait Innovation Application

Regulatory News:

Theraclion (Paris:ALTHE) (Alternext, FR0010120402 – ALTHE, eligible for PEA PME plans), a company specialising in leading-edge medical equipment for echotherapy, today announced that on June 21, 2016, it received a request for additional information from France's national health authority HAS (Haute Autorité de Santé) relating to its application for the Forfait Innovation.

As a reminder, in January 2016, Theraclion filed an application for the Forfait Innovation, which was deemed admissible in April. Theraclion was the first company to apply for the Forfait Innovation exceptional funding mechanism, in its definitive version as set out in the government decree of February 16, 2016. The information submitted as part of the request for exceptional reimbursements has not yet resulted in a positive opinion regarding eligibility.

The request received on June 21, 2016 seeks clarification regarding the subgroup eligibility criteria of women who are treatment candidates. As a result, Theraclion is planning to update its initial application in response to the HAS opinion.

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

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