EDAP TMS Retains Greenleaf Health as Strategic Advisor on U.S. FDA Submission
Strengthens Team for Final Stages of Ablatherm-HIFU Phase II/III Clinical Trial for Prostate Cancer
EDAP TMS SA today announced the retention of Greenleaf Health LLC, a full service regulatory consulting firm. Greenleaf Health will provide the Company with high-level strategic guidance regarding the final stages of its Ablatherm-HIFU (High Intensity Focused Ultrasound) ENLIGHT U.S. Phase II/III clinical trial for the indication of low risk, localized prostate cancer.
Greenleaf Health offers strategic guidance to healthcare sector clients whose activities are regulated by the Food and Drug Administration (FDA), and to those developing innovative solutions to pressing public health challenges. The Greenleaf Health team includes former leaders from the FDA, Capitol Hill, top global pharmaceutical companies, and the leading U.S. biotechnology trade organizations.
Marc Oczachowski, Chief Executive Officer of EDAP-TMS, stated, "Greenleaf Health joins the existing EDAP team of experts both internal and external, inclusive of specialized legal, regulatory, and Clinical Research Organization advisors, that has been working together to advance Ablatherm-HIFU through Phase III. As we progress through the final stages of our U.S. ENLIGHT clinical trial, this is an opportune time to bring Greenleaf on board. They will bring their strategic expertise to their role as advisor as we move forward in our Premarket Approval (PMA) filing to the U.S. FDA in the fourth quarter of 2012 and progressing through the regulatory process in the coming year."
Patrick Ronan, founder and President of Greenleaf Health, said, "The use of HIFU as a therapeutic option to treat localized prostate cancer shows great potential for the hundreds of thousands of men in the U.S. who are diagnosed each year with this disease. We look forward to working closely with the team at EDAP to provide strategic guidance through the FDA regulatory process for its Phase III submission."
About Greenleaf Health LLC
Greenleaf Health is a full service regulatory consulting firm that provides strategic guidance to companies regulated by the FDA and companies developing innovative solutions to pressing public health challenges around the globe and to a select group of healthcare sector clients, including pharmaceutical, biotechnology and medical device companies whose activities are regulated by the FDA. The Greenleaf team includes former leaders from FDA, Capitol Hill, top global pharmaceutical companies and the leading U.S. biotechnology trade organization. The wealth of experience allows the Greenleaf team to understand the broad health care industry, while appreciating the business challenges facing health care companies in a rapidly changing environment.