EDAP TMS S.A. (EDAP)

[jupp]

Key points from Mr. Oczachowski included:

Ablatherm-HIFU has a proven safety record through its approval and use in markets including Europe, Canada, Russia, Brazil, Mexico and South Korea;
Ablatherm has treated more than 40,000 prostate cancer patients worldwide since its initial CE Mark approval in 2000;
Recently the French Ministry of Health approved HIFU reimbursement for primary care patients at the same level as surgery;
The Panel apparently agreed that the current approval path for new prostate cancer treatments is prohibitive and the likelihood that existing therapies, if evaluated on today's requirements, would be unlikely to qualify for a positive vote;
Mr. Oczachowski added, "We believe there is strong clinical evidence supporting the safety of our Ablatherm Integrated Imaging HIFU device. Indeed after 15 years of routine use, we see a growing adoption of the technology with approximately 4,000 treatments performed annually. To date, there have been no restrictions placed on the use of Ablatherm-HIFU from any of the numerous regulatory authorities under which it has been approved. If Ablatherm HIFU was dangerous or unsafe, it would not have survived more than five years in any market and would not be used by any urologist or would be forbidden by regulatory authorities around the world, this is not the case. We also believe that if it was not effective nor answering some patient needs, urologists around the world would have stopped using it."

www.benzinga.com/news/14/08/4756256/edap-ceo-comments-on-frustration-with-fda-panel

Mr. Oczachowski concluded, "Based on the panel comments, we could interpret that applying today's standards to all available treatment options would result in no therapeutic options for low-risk prostate cancer patients in the U.S. Finally, we strongly believe that there are probably more risks in excluding a technology that has 15 year proven experience from the American patient choice than having it available in a controlled and monitored environment in the country, as it could result in an increasing HIFU medical tourism with the known risks associated."