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Theraclion SA

Regulatory Filings Oct 13, 2014

1701_iss_2014-10-13_b40c49f0-4a00-4401-ac67-d883ae6076f0.pdf

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THERACLION joins the 4th International Symposium on Focused Ultrasound October 12-16, 2014

Malakoff, FRANCE – October 13th, 2014 – THERACLION (Alternext, FR0010120402 - ALTHE, eligible for the PEA-PME, a tax-exempt share savings plan for SMEs), a company specializing in cutting-edge medical equipment for echotherapy, announces today its participation to the 4th International Symposium on focused ultrasound, which will be held this month at the Bethesda North Marriott Hotel & Conference Center in the Washington D.C. metropolitan area, from October 12 to 16.

Hosted by the Focused Ultrasound Foundation, this symposium is the single most significant international conference dedicated to high-intensity focused ultrasound (HIFU) therapy, bringing together every year the leading experts, researchers and practitioners in the field, alongside key players in the industry. The event, whose previous edition was attended by over 350 people from 24 countries, will look into current and future applications of focused ultrasound, one of the most promising and innovative therapeutic technologies today.

As part of this year's symposium, a conference will take place on October 15th at 11.30am, featuring three studies on the treatment of breast fibroadenoma by HIFU under ultrasound guidance, all conducted with the support of Theraclion, respectively in the United States, Bulgaria and the United Kingdom:

  • · Dr. David Brenin will introduce the audience to the very encouraging feasibility study he has been conducting on 20 patients suffering from breast fibroadenoma at the University of Virginia, U.S.A., for which Theraclion was granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA), the first step toward obtaining the agency's PMA (Premarket approval) in the United States.
  • · Dr. Roussanka Kovatcheva will share the highly promising results of a prospective study carried out on 20 patients at the University Hospital of Endocrinology of Sofia, Bulgaria, evaluating the efficiency and safety of the treatment of breast fibroadenoma by echotherapy.
  • · Dr. Mirjam Peek of King's College London, U.K., will present the results of trials emphasizing the positive impact of the non-invasive treatment of breast fibroadenomata with the Echopulse® device.

Next to these studies on the treatment of breast fibroadenoma, a dedicated panel will detail the very positive results garnered by trials conducted in Bulgaria, under Dr. Kovatcheva's leadership, on the noninvasive treatment of thyroid nodules through HIFU.

In addition, at the Focused Ultrasound Showcase that will be held on October 13, David Caumartin, CEO of Theraclion, will give a talk about the company and its pioneer echotherapy treatment of breast fibroadenoma and thyroid nodules. Echotherapy, which is performed as an outpatient procedure and does not require general anesthesia, offers a non-invasive alternative to other available treatments.

Link to the 2014 symposium's program: http://www.fusfoundation.org/web/symposium/program.html.

About Theraclion

Theraclion is a French company specializing in cutting-edge equipment for echotherapy. Theraclion designs, develops and markets a high-tech medical device, the Echopulse®, which combines advanced ultrasound imaging and high-intensity focused ultrasound therapy. Theraclion is ISO 13485 certified and has received the CE mark for non-invasive 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, please visit http://www.theraclion.com.

Theraclion is listed on Alternext Paris Eligible for the PEA-PME, a tax-exempt share savings plan for SMEs Ticker symbol: ALTHE – ISIN code: FR0010120402

Contacts:

Theraclion NewCap Phone: +33 (0)1 55 48 90 70 Phone: +33 (0)1 44 71 94 91 [email protected] [email protected]

David Caumartin Financial Communications & Investor Relations CEO Emmanuel Huynh / Sophie Boulila

ALIZE RP

Communication and Press Relations Caroline Carmagnol / Valentine Boivin Phone: + 33 (0)1 70 22 53 92 / + 33 (6) 83 48 23 27 [email protected]

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