MALAKOFF, France--(BUSINESS WIRE)--Regulatory News:
THERACLION (Alternext, FR0010120402 – ALTHE) (Paris:ALTHE), a company specialized in leading-edge medical equipment for echotherapy, announces today that the first patient of the «Forfait Innovation » study was included at Groupe Hospitalier Diaconesses Croix Saint Simon (GHDCSS) in Paris.
« Forfait Innovation » was created by the French Ministry of Health to
facilitate market access to innovation technologies. Treatments
performed within the frame of the program are reimbursed by the national
health system. Theraclion is the first company to benefit from this
process in its new format defined in 2015.
The payment partially covers the cost of the study which compares the cost-effectiveness and the efficacy of high intensity focused ultrasound versus surgery. The study includes 300 patients, split between HIFU and surgery, treated in 12 different sites listed hereafter. Treatment coverage will apply to more patients after the end of the study.
List of participating sites:
- Groupe Hospitalier Diaconesses Croix Saint – Simon Site Avron, Paris 20e
- HOPITAL Tenon, Paris 20e
- HOPITAL Saint Louis, Paris 10e
- HOPITAL Pitié-Salpêtrière, Paris 13e
- American Hospital of Paris, Neuilly-sur-Seine
- CHU de Strasbourg - Hôpital Hautepierre - Unité de Sénologie
- Hôpital Européen, Marseille
- CHU de Montpellier, Hôpital Lapeyronie
- Clinique Mutualiste La Sagesse, Rennes
- Polyclinique de l'Atlantique, Saint Herblain
- Polyclinique Majorelle, Nancy
- Centre Hospitalier de Valenciennes
«We are proud to be the principal investigator in this newly created process which gives patients an access to ground-breaking innovative technologies. The first patient was included and we expect more inclusions shortly. We believe that this technology will play a key role in the treatment of breast lesions” says Professor Richard Villet, president of the French National Academy of Surgery, member of the French National Academy of Medicine and Head of Visceral and Gynecologic Surgery in GHDCSS.
“Obtaining “Forfait Innovation” was a long process”, concludes Anja Kleber, VP Marketing and Market Access, “ but the study will demonstrate the efficacy of echotherapy from a health economic point of view. This will have a significant impact discussion with national health insurance organizations around the world.”
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 35 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 Euronext Growth Paris
Mnemonic: ALTHE - ISIN Code: FR0010120402