TORONTO, ONTARIO--(Marketwired - Sept. 17, 2013) - Titan Medical Inc. ("Titan" or the "Company") (TSX VENTURE:TMD)(OTCQX:TITXF) has announced that Dr. Dennis Fowler has accepted the position of Director of Clinical Affairs. Dr. Fowler will be responsible for clinical affairs and Titan's regulatory approval process plan, including its pre-clinical and clinical testing strategy. He will work closely with the clinical regulatory department of Ximedica, a medical products development firm, in solidifying Titan's clinical strategy for the regulatory review and approval by the U.S. Federal Drug Administration (FDA) and by the European Union of the Single Port Orifice Robotic Technology (SPORT(TM)) surgical system.
"Titan is delighted to have Dr. Dennis Fowler as our Director of Clinical Affairs. Dr. Fowler is one of the co-inventors of the SPORT(TM) surgical system and has a long, storied career of being an innovator and leader in adopting and implementing minimally invasive surgery techniques in the operating room. We are thrilled to have him, with his vast experience and knowledge, lead our clinical regulatory strategy," said John Hargrove, CEO of Titan Medical.
Dr. Fowler and Titan also announced today that they are implementing a regulatory approval process plan, prepared in conjunction with Ximedica, for the submission of its SPORT(TM) surgical system to regulators for approval in Titan's two major target markets - the United States and the European Union. The regulatory approval process plan maps the appropriate pathway through both the FDA and the European Union regulatory approval processes and is based on Ximedica's review of the SPORT(TM) technology and the intended indications for its use. With the guidance and leadership of Dr. Fowler, the plan, which identifies the specific FDA and European Union requirements that Titan must meet and outlines a detailed process for meeting those requirements, will be implemented. This regulatory approval process plan is expected to reduce the regulatory approval timeline.
"The clinical regulatory team at Ximedica will play a major role in supporting Dr. Fowler's efforts to develop and implement Titan's regulatory approval process plan to obtain approval of the SPORT(TM) surgical system in our two major target markets. Addressing regulatory compliance issues well before the product is submitted to the regulators for approval will contribute to a sustainable, successful business model and ensure that Titan attains its milestones on time, on budget, and in accordance with our projected 2015 commercial launch of our SPORT(TM) surgical system." said Titan CEO John Hargrove.
Dr. Dennis Fowler
Prior to being appointed Director of Clinical Affairs at Titan, Dr. Fowler was a consultant to Titan. He is the co-inventor of the single-incision Insertable Robotic Effector Platform (IREP) technology licensed from Columbia University for use in Titan Medical's SPORT(TM) Surgical System. Dr. Fowler received his M.D. in 1973 from the University of Kansas School of Medicine, Kansas City. In 2008 he received his Master of Public Health from Columbia University, Mailman School of Public Health. Dr. Fowler is certified by the American Board of Surgery and is a member of numerous surgical societies. Currently, he is the Gerald and Janet Carrus Professor of Surgical Science and Director of the Center for Innovation and Outcomes Research in the Department of Surgery, Columbia University College of Physicians and Surgeons and is also Medical Director of the Simulation Center, New York Presbyterian Hospital/Columbia University Medical Center. He also has a vast list of honours, committee positions, teaching responsibilities and publication credits. To view Dr. Fowler's curriculum vitae please visit http://asp.cumc.columbia.edu/facdb/profile_list.asp?uni=dlf91&DepAffil=Surgery.