New Echopulse® Sales Agreement and First International Publication on a Clinical Study on Breast Fibroadenomas Confirm Theraclion’s Strategy

Regulatory News:

THERACLION (Paris:ALTHE) (Alternext, FR0010120402 - ALTHE) a company specializing in cutting-edge medical equipment for echotherapy, announced today that HELIOS Klinik Schkeuditz has acquired the Echopulse® system. This acquisition is the first in a private institution in Germany and the first in the Eastern part of Germany, furthering patient access to this novel treatment modality.

"We’re excited to begin offering echotherapy to our patients as a non-invasive, outpatient treatment option,” said Melanie Rosche, CEO of HELIOS Klinik Schkeuditz. "The Echopulse® represents a targeted therapeutic solution for the treatment of the most common form of benign breast tumors and for benign thyroid nodules and provides a favorable esthetic result for our patients,” said Kerstin Winkler, MD, head of the Gynecology and Obstetrics division at HELIOS Klinik Schkeuditz.

The acquisition of the Echopulse® system followed a report of the first study describing clinical outcomes after echotherapy of fibroadenomas, which was posted online on 24 November 2014 in the peer-reviewed journal "Expert Review of Medical Devices.” It is authored by B. Cavallo Marincola and coworkers from Policlinico Umberto I, Sapienza University of Rome, Italy.

This new study followed 10 female patients between the ages of 18 and 34 who were treated for breast fibroadenomas using the Echopulse® System. Treatments were performed using local anesthesia with mild conscious sedation. None of the patients felt pain at the time of treatment nor did they report any type of pain during the follow-up period of 3 months. At the time of the follow-up visit, all treated patients showed a reduction of fibroadenoma volume of at least 50 percent and no adverse events were reported except mild swelling and hardness of the treated area.

Compared to MR-guided HIFU (High Intensity Focused Ultrasound), ultrasound-guided HIFU (technology used by the Echopulse® system) showed benefits including shorter treatment time, more comfortable patient positioning avoiding large movements during the procedure, and the absence of contrast agents administered before and after treatment.

"Echotherapy presents a remarkable surgical alternative for patients who decline surgery, want to avoid surgical scarring, or who are not candidates for conventional surgery for medical reasons,” said Beatrice Cavallo Marincola, MD, Policlinico Umberto I, Sapienza University of Rome. "For benign lesions, the use of ultrasound guidance instead of MR makes it a cheaper, simpler and more agreeable option for the patient.”

"The acquisition of the Echopulse® system by HELIOS Klinik Schkeuditz and the first publication of treatment outcomes are important milestones for Theraclion,” said David Caumartin, CEO of Theraclion. "It confirms that echotherapy is an accurate, non-invasive alternative to surgery for patients. These two important news are enabling patients better access to this innovative technology.”

With this new installation, the Echopulse® System will be in use in 11 institutions throughout the globe. Theraclion is currently the only company in the world offering a completely non-invasive treatment for breast fibroadenomas and benign thyroid nodules.

About Theraclion

Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound. Drawing on cutting-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 23 people, 65 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
Eligible for the PEA-PME, a tax-exempt share savings plan for SMEs
Ticker symbol: ALTHE – ISIN code: FR0010120402