EDAP TMS has received reimbursement for prostate cancer (PCA) treatment procedures using the company's high-intensity focused ultrasound (HIFU), by French health authorities. The French Minister of Social Affairs and Health outlined the acceptance of HIFU treatment for PCA for reimbursement during a visit to the company's headquarters on April 18.
EDAP currently markets Ablatherm for HIFU treatment of localised PCA. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localised PCA (Stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.
Ablatherm-HIFU is approved and commercialised in Europe as a treatment for PCA and is currently under regulatory review in the US following submission of A PMA application in February 2013 after the completion of a multicentre US Phase II/III trial under an IDE granted by the FDA. Also in February 2013, EDAP introduced a new HIFU device, Focal One, dedicated to focal therapy of PCA. Focal One is CE-marked but is not FDA-approved. The company also develops its HIFU technology for the potential treatment of certain other types of tumours.