Tübingen University Publishes Positive Results on Echotherapy Breast Fibroadenoma Clinical Trial and Enters a Commercial Agreement with Theraclion

Regulatory News:

THERACLION (Paris:ALTHE) (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy (US-guided High-Intensity Focused Ultrasound treatment), announces today that the University of Tübingen, Germany, has published an article in the "Senologie Journal” entitled "Thermosurgical ablation of breast fibroadenoma” (BFA), presenting its experience with the Echopulse system for the treatment of BFA. As the satisfactory study results have convinced Tübingen University to offer echotherapy in routine clinical practice to its patients, a commercial agreement has been concluded between Theraclion and the Institution.

Positive results of the clinical study on Echotherapy breast

Beginning in December 2013, the "Frauenklinik” of the University of Tübingen conducted a clinical study on 27 patients to evaluate the safety and efficacy of echotherapy for the treatment of breast fibroadenoma, which is the most common form of benign breast tumor.

The University has published an article reporting its preliminary experience. The study demonstrates:

• FA volume was significantly reduced in all patients compared to baseline with complete ablation or downsizing of the FA.
• FA symptoms (including pain and discomfort) either disappeared or were significantly reduced following echotherapy.
• No recurrence or incidence of regrowth have been observed up to 12 months post treatment
• Echotherapy procedures were very well tolerated with a scar-free process providing good cosmetic outcomes while avoiding complications associated with surgical incisions.
• All patients reported high satisfaction levels and would recommend echotherapy to other persons or would repeat the procedure on a second FA.

The author of the article, Professor Markus Hahn, Chief Breast Surgeon at Tübingen University concluded: "Our results demonstrate that HIFU is a promising new treatment option for breast fibroadenoma ".

Commercial agreement between Tübingen University and Theraclion to offer echotherapy in routine clinical practice

Based on positive results from its clinical study, the University of Tübingen has decided to sign a commercial agreement with Theraclion to offer echotherapy to its patients. Tübingen University is Germany’s first certified breast center and one of the most modern breast clinics in Europe. The Center is nationally and internationally recognized for its expertise in teaching and research. It performs more than 700 breast cancer surgeries every year.

"Tübingen University is the first major German University adopting echotherapy to treat breast fibroadenoma”, says José Abellan, VP Central Europe. "The University is an important reference center and will help drive clinical adoption of this innovative treatment technique that is scarless and delivered under simple local anaesthesia.”

David Caumartin, CEO Theraclion, says : "The published results confirm the safety and the efficacy of Theraclion’s echotherapy solution. We also welcome the fact that the University has decided to continue our collaboration beyond the initial purely academic scope. Tübingen is a strategic partner for us in Germany and we appreciate, with Professor Hahn, the engagement of one of the most renowned breast surgeons in Germany.”

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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