In August, EDAP confirmed the completion of all follow-up visits in connection with its Ablatherm-HIFU ENLIGHT U.S. clinical trial for the indication of low risk, localized prostate cancer. The Company is on track to file its Premarket Approval (PMA) with the U.S. FDA in the fourth quarter of 2012.
In June, EDAP's experts in HIFU technology presented their recent advances in the development of therapeutic focused ultrasound at the 12th International Symposium of Therapeutic Ultrasound (ISTU 2012) held in Germany. Top level technical presentations from the Company's partner INSERM, a French public research laboratory, addressed the successful evaluation of HIFU technology in targeting liver cancer. Other presentations related to HIFU as a therapy for prostate cancer, and included a poster that examined data from large cohorts of prostate cancer patients treated with the Ablatherm-HIFU over more than ten years, computed from a comprehensive clinical registry. The long-term results confirm EDAP as the most advanced player in the use of HIFU to address prostate cancer.
During the second quarter, the United Kingdom's National Institute for Health and Clinical Excellence (NICE), an independent organization that advises the National Health Service (NHS) on treatment and care, published guidance regarding focal therapy using HIFU to treat localized prostate cancer. In its International Procedure Guidance 424 on focal HIFU, NICE highlighted the 'potential for focal HIFU to avoid many of the complications of more radical treatment procedures' for localized prostate cancer in properly selected patients.
During the second quarter, EDAP's Ablatherm-HIFU was successfully utilized by leading urology surgeons at the St-Augustin Urology Clinic in Bordeaux, France to eradicate prostate cancer tumors via a focal approach. This highly regarded urology practice is now positioning the focal therapy procedure using EDAP's device as a 'must have complement' to robotic surgery.In May, EDAP showcased its Ablatherm-HIFU and its Sonolith i-move at the American Urological Association (AUA) 2012 Annual Meeting. Prostate cancer data generated using Ablatherm-HIFU was featured in two scientific sessions at AUA and in three poster presentations at the 27th Annual Meeting of the Engineering and Urology Society that was held concurrently with the AUA. EDAP experienced record attendance from U.S. urologists at its AUA booth.