Michael Barbella, Managing Editor03.04.24
EDAP TMS SA said the French National Authority for Health (HAS) has released a favorable recommendation for reimbursing high-intensity focused ultrasound (HIFU) therapy in treating prostate cancer. The positive opinion from HAS is an important milestone along the regulatory pathway of securing final reimbursement in France.
"We are pleased to receive this positive opinion from the HAS, which we believe reflects the outstanding safety and favorable clinical outcomes from use of Focal One Robotic HIFU in the HIFI study that included more than 3,000 prostate cancer patients,” EDAP CEO Ryan Rhodes said. “This decision brings us one step closer toward securing reimbursement coverage from the French Social Security authorities, as we seek to expand treatment options for physicians and their patients with our Focal One HIFU technology platform.”
Following the completion and analysis of an HIFI study sponsored by the French Urology Association and submitted to the HAS, a positive favorable opinion was issued to include HIFU as a procedure covered under the national universal health, Social Security system (Sécurité Sociale). More specially, the favorable opinion relates to HIFU as a primary treatment of intermediate localized prostate cancer risk as well as a salvage option after failed radiotherapy. Based on this positive opinion from the HAS, the French Social Security authorities can now use this recommendation for including HIFU procedures in its next cycle to determine the procedure’s reimbursement rate and the timing for when such reimbursement would go into effect.
A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One in Europe and in the United States as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer, according to the firm. EDAP TMS also produces and distributes other medical equipment including the Sonolith i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).
An independent, scientific public authority, the Haute Autorité de Santé (HAS) aims to develop quality in the healthcare, social and medico-social fields. It works alongside public authorities, helping them to make informed decisions, with professionals to optimize their practices and organizations, and for the benefit of users, empowering them to make their own choices. It was created by the French Health Insurance Act on Aug. 13, 2004.
"We are pleased to receive this positive opinion from the HAS, which we believe reflects the outstanding safety and favorable clinical outcomes from use of Focal One Robotic HIFU in the HIFI study that included more than 3,000 prostate cancer patients,” EDAP CEO Ryan Rhodes said. “This decision brings us one step closer toward securing reimbursement coverage from the French Social Security authorities, as we seek to expand treatment options for physicians and their patients with our Focal One HIFU technology platform.”
Following the completion and analysis of an HIFI study sponsored by the French Urology Association and submitted to the HAS, a positive favorable opinion was issued to include HIFU as a procedure covered under the national universal health, Social Security system (Sécurité Sociale). More specially, the favorable opinion relates to HIFU as a primary treatment of intermediate localized prostate cancer risk as well as a salvage option after failed radiotherapy. Based on this positive opinion from the HAS, the French Social Security authorities can now use this recommendation for including HIFU procedures in its next cycle to determine the procedure’s reimbursement rate and the timing for when such reimbursement would go into effect.
A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One in Europe and in the United States as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer, according to the firm. EDAP TMS also produces and distributes other medical equipment including the Sonolith i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).
An independent, scientific public authority, the Haute Autorité de Santé (HAS) aims to develop quality in the healthcare, social and medico-social fields. It works alongside public authorities, helping them to make informed decisions, with professionals to optimize their practices and organizations, and for the benefit of users, empowering them to make their own choices. It was created by the French Health Insurance Act on Aug. 13, 2004.