TORONTO, ON–(Marketwired – May 25, 2016) – Titan Medical Inc. (TMD.TO)(TITXF) today announced it has signed a three month extension of the exclusive rights granted to Longtai Medical Inc. to negotiate a potential exclusive marketing, sales and distribution agreement for Titan’s SPORT™ Surgical System in the Asia Pacific Region. The granting of exclusive rights to negotiate a distribution agreement was part of a previously disclosed Letter Agreement with Longtai. The extended negotiation period will expire on August 19, 2016.
In addition, based on the recently published FDA guidance document “Applying Human Factors and Usability Engineering to Medical Devices,” Titan reported today that it has initiated usability studies for its SPORT Surgical System to comply with the recommendations in that document. The current usability studies are formative evaluations undertaken by Titan to inform final design and involve critical task identification, cognitive walk-through testing and simulated use testing. The outcomes from these studies include identification of system use-related issues that will be addressed through further engineering to eliminate or reduce use-related hazards.
Commenting on the negotiation extension, Reiza Rayman, President of Titan Medical Inc. commented, “We have had very productive discussions with Longtai regarding our two companies teaming up to maximize the potential of Titan’s SPORT™ Surgical System in the China market. This three month extension enables both companies to continue to discuss a wide variety of topics designed to negotiate a potential comprehensive agreement benefiting both companies.”
Commenting on the initiation of the SPORT Surgical System usability studies, John Hargrove, Chief Executive Office of Titan said, “As we recently reported, on April 3rd the FDA published updated guidelines titled “Applying Human Factors and Usability Engineering to Medical Devices” and Titan has revised its timeline and milestones for submission of a 510(k) application to the FDA to include detailed attention to these new guidelines. The first step in this process is the initiation of usability studies. We are well into these studies, which are conducted to enable SPORT to comply with FDA requirements, and expect to complete the current studies by the end of the current year. Successful outcomes will play a major role in the system design freeze during the first half of 2017.”
About Titan Medical Inc.
Titan Medical Inc. is a Canadian public company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (“MIS”). The Company’s SPORT™ Surgical System, currently under development, includes a surgeon-controlled robotic platform that incorporates a 3D high-definition vision system and multi-articulating instruments for performing MIS procedures through a single incision. The surgical system also includes a surgeon workstation that provides a surgeon with an advanced ergonomic interface to the robotic platform for controlling the instruments and provides a 3D high-definition endoscopic view of inside a patient’s body. The SPORT™ Surgical System is designed to enable surgeons to perform a broad set of surgical procedures for general abdominal, gynecologic, and urologic indications. For more information, visit the Company’s website at www.titanmedicalinc.com.
About Longtai Medical Inc. and Ningbo Long Hengtai International Trade Co. Ltd.
Longtai is a British Columbia corporation associated with Ningbo Long Hengtai International Trade Co. Ltd., a corporation engaged in the distribution of medical device and related products in China. Longtai is owned by one or more members of Shiguang Ling, Chairman of Ningbo Long Hengtai International Trade Co. Ltd.
Ningbo Long Hengtai International Trade Co. Ltd. is engaged in the distribution of medical equipment in China through a substantial network of sub dealers and serves a number of medical device companies including a leading European provider of diagnostic imaging and healthcare IT solutions for hospitals and care centers around the world.
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 March 30, 2016 (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.