MALAKOFF, France--(BUSINESS WIRE)--Regulatory News:
THERACLION (Paris:ALTHE) (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, announces today its first sale of a system to be utilized in the French “Forfait Innovation”.
The “Forfait Innovation” (reimbursement for innovation) is a measure taken by the Ministry of Health whose objective is to facilitate patient access to innovative technologies. It consists of a derogatory and transitional reimbursement of treatments performed with the new technology. Theraclion is the first company to have obtained the Forfait Innovation since its reform in 2015.
The Forfait Innovation allows a partial financing of a health-economic study which has as its objective to demonstrate that the treatment of breast fibroadenomas by Echotherapy (High Intensity Focused Ultrasound - HIFU) is less expensive and as effective as surgery. This study will include 300 patients in 12 centers. Patients will be followed up for eighteen months. After the completion of patient inclusions, the 12 participating centers will be able to continue to offer Echotherapy routinely using the same reimbursement code.
The program’s kick-off meeting with the 12 centers was held on April 13th.
"According to the HAS (Haute Autorité de Santé), the “Forfait Innovation” is a fast track to obtain, following the study, the general reimbursement of the procedure" says Anja Kleber, Theraclion Vice President Marketing and Head of sales in France. "This study will, thanks to the “Forfait Innovation,” be beneficial well beyond French borders. The study represents the first randomized study worldwide and the first health-economic study of Theraclion's completely non-invasive treatment solution."
The system was sold to EDAP, a French company specialized in HIFU. EDAP designs and manufactures equipment for the non-invasive treatment of prostate cancer. EDAP offers the system for sale but has also developed a model to offer shared systems. These mobile systems are rented to different users on a fee-for-service basis. This same logistics will be used for this first Echopulse® from Theraclion.
"This is a first step in a partnership that will make it possible to implement the synergies of our respective portfolios and to exploit the commercial potential of HIFU," adds Pierre Reboul, EDAP TMS France BU Director.
"The collaboration with EDAP makes it possible to offer hospitals a broader HIFU portfolio," concludes David Caumartin, Theraclion's CEO. "This sale of an Echopulse® is already the third sale this year for Theraclion and the first in France since 2014 when Theraclion sold an Echopulse® to the American Hospital of Paris. We are pleased to see the impact of the “Forfait Innovation” coverage on our national market".
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