Titan Medical Inc.

Titan Medical Inc.

September 17, 2013 09:05 ET

Titan Medical Inc. Announces Dr. Dennis Fowler as Director of Clinical Affairs and the Completion of a Regulatory Approval Process Plan

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™) 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™ 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™ 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™ 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™ 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™ 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™ 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.

About Ximedica

Ximedica is a full service ISO 13485 certified and FDA registered product development firm with an exclusive focus on medical products. With more than 25 years of experience developing medical devices, combination products and consumer healthcare products, Ximedica's client base spans the globe and ranges from start-ups to the world's largest medical device manufacturers. Ximedica's mission is to create products that meet international regulatory requirements and strategic business goals. For more information, visit the Company's website at www.ximedica.com.

About Titan Medical Inc.

Titan Medical Inc. is a Canadian public company (TSX VENTURE:TMD)(OTCQX:TITXF) focused on the design and development of a robotic surgical system for application in minimally invasive surgery ("MIS"). The Company's robotic surgical system, currently under development, comprises a surgeon-controlled robotic platform that includes a 3D vision system and interactive instruments for performing MIS procedures, and a surgeon workstation that provides the surgeon with an interface to the robotic platform for controlling the interactive instruments and providing a 3D endoscopic view inside a patient's body during MIS procedures. The robotic surgical system is being designed to expand robotic surgery into areas of surgical specialties and simple and complex procedures that are currently under-serviced, and to allow surgeons to perform procedures within small to medium size surgical spaces such as general surgery and cholecystectomy. For more information, visit the Company's website at www.titanmedicalinc.com.

Forward Looking Statements

This news release contains "forward-looking statements" which reflect the current expectations of management of the Company's future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as "may", "would", "could", "will", "anticipate", "believe", "plan", "expect", "intend", "estimate", "potential for" and similar expressions have been used to identify these forward-looking statements. These statements reflect management's current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the "Risk Factors" section of the Company's Annual Information Form dated April 10, 2013 (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.

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