Regulatory News:

Theraclion (Paris:ALTHE) (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, today announced the continued strengthening of its market position in Germany with coverage of its echotherapy by more public insurance companies as well as two commercial agreements for Echopulse® installations in Frankfurt for the treatment of benign thyroid nodules.
Insurance coverage for echotherapy for thyroid nodules now includes “Die Techniker (TK)”, the largest German insurance company, covering approximately 9.7 million members.

“Coverage by big insurers such as members of the AOK group or the TK shows that payors acknowledge the payor benefit and patient benefit echotherapy can bring,” said Anja Kleber, VP Marketing and Market Access of Theraclion.

Theraclion also signed agreements with two hospitals in Frankfurt, the first German city with two Echopulse® systems available to treat thyroid nodules.

The first commercial agreement concerns the Bürgerhospital that has decided to purchase the system that it was renting from Theraclion from one year. The Bürgerhospital of Frankfurt is a hospital featuring an endocrine surgery center of excellence with approximately 1,400 thyroid surgeries performed annually. It is one of a few centers of reference for endocrine surgery certified by the German Society for General and Visceral Surgery (DGAV). Within this context, Bürgerhospital is responsible for continued education of other German endocrine surgical centers and is on the forefront of clinical development and deployment of innovation.

“When we started to use the Echopulse® system one year ago, our aim was to evaluate the system’s performance while collecting clinical data,” commented Dr. Christian Vorländer, head of the Endocrine Surgery Department of Bürgerhospital. “Our experience with the Echopulse® system confirmed our view that a non-invasive treatment approach can safely and effectively benefit our patients and provide a new direction to the treatment of thyroid nodules in Germany.”

Secondly, the University hospital of Frankfurt has signed a commercial agreement with Theraclion following initial clinical investigations on echotherapy treatments that resulted in several scientific publications. The German Thermoablation Center (DTZA) of the University Hospital will provide echotherapy in a routine clinical setting to their patients with thyroid nodules. The DTZA is the first institution in Germany to offer a complete portfolio of several thermoablative techniques, such as echotherapy, radiofrequency and microwave procedures to their patients. This marks the tenth echotherapy system installed in Germany, the most in any country worldwide

“It is important for us to be able to offer a range of choices for our patients to best fit their needs,” explained Prof. Grünwald, President of the DZTA at the University Hospital Frankfurt. ”Echotherapy has the advantage of being the only completely non-invasive procedure.”

David Caumartin, CEO of Theraclion concluded, “Germany is our initial target market and it is very gratifying that Echopulse® continues to gain traction there through expanded insurance coverage and the two commercial agreements. Today’s news, along with recent announcements of derogation reimbursement in France and the upcoming initiation of our U.S. clinical trial of Echopulse® for breast fibroadenoma demonstrate our accelerating business momentum.”

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