Theraclion’s New BEAMOTION Procedure Obtains CE Mark

Regulatory News:

THERACLION (Paris:ALTHE) (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, announces today the placement of a CE Mark on the newly developed BEAMOTION procedure. The BEAMOTION technology has been designed to significantly reduce Echopulse treatment time. The CE Mark enables Theraclion to sell the new technology within the European Union and Switzerland as well as in non-European countries accepting the CE Mark.

In parallel, the technology was featured during the French Senology Congress in Bordeaux, November 11-13.

"Theraclion’s fast procedure "BEAMOTION” has been developed thanks to the unique know-how of our R&D and clinical teams,” declares Sylvain Yon, PhD, Deputy CEO and VP R&D of Theraclion. "This new concept, which leverages our formidable intellectual property platform, has been validated through ex-vivo and in-vivo animal trials as well as through rigorous clinical studies. It is a breakthrough in the HIFU industry that puts our technology among the fastest thermal ablation alternatives, fully-retaining the non-invasive nature of the intervention.”

The new technology was presented during Theraclion's first symposium organized during the annual conference of the French Senology Society. This conference is the largest annual event uniting different medical specialties in breast care from France and other French speaking countries. Approximately 200 participants attended the symposium chaired by Professor Villet, Groupe Hospitalier Diaconesses Croix Saint-Simon (GHDCSS), Paris.

"Fibroadenoma is the most common form of benign breast tumor and occurs in around 10% of women," said Dr. Maitrot-Mantelet of the endocrine gynecology unit at Hôpital Cochin, AP-HP, Paris, France. She confirmed that "for simple, symptomatic fibroadenoma, echotherapy [the treatment delivered by the Echopulse] is now a true alternative to surgical intervention."

"Fibroadenoma mostly occurs in young women who are less than 35. Echopulse has its place in the therapeutic arsenal we can offer to these patients," added Dr. Levy, Radiology Institute of Paris. "Echopulse provides a non-invasive treatment alternative. We see excellent results with high patient satisfaction and pleasing aesthetic outcomes," concluded Dr. Abehsera, American Hospital of Paris, Neuilly-sur-Seine, France and concluded his presentation with the fact that "the BEAMOTION technology speeds up the treatment by a factor of 5.”

In addition to the Echopulse symposium, the new BEAMOTION technology was also presented over an oral communication and a poster during the official scientific program of the congress by Dr. Grivaud-Martin from the GHDCSS, Paris.

"Attendance at the symposium clearly reflects strong interest from the French community of surgeons and radiologists who seek to propose a non-invasive treatment solution to fibroadenoma. Our new CE marked BEAMOTION procedure meets the speed requirement of users and brings more comfort to patients,” says David Caumartin, CEO Theraclion. "We are extremely satisfied by the customer feedback received during the French Senology Congress in Bordeaux. In the coming few days, we will start the roll-out of BEAMOTION to our installed base and launch new installations expanding our reach to more women in need of better care".

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 30 people, 53 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
PEA-PME Eligible
Mnemonic: ALTHE - ISIN Code: FR0010120402

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