Titan Medical Announces Completion of Pre-Clinical GLP Studies

Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company focused on the design and development of surgical technologies for robotic single access surgery, announced today that it has completed its scheduled pre-clinical studies with its Enos robotic single access surgical system, performed in accordance with FDA’s good laboratory practice (GLP) regulations. GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support marketing permits for products regulated by government agencies.

Titan’s pre-clinical studies involved utilizing the Enos system to perform hysterectomies in porcine subjects. Initial testing has been successfully completed and in accordance with GLP principles, further tests on the subjects were run post-surgery and pathology results are expected over the next several months. The COVID-19 pandemic has impacted the processing time at laboratories, resulting in a longer than expected turnaround time for results. With the completion of these studies, surgeons have now performed over 70 pre-clinical procedures representing multiple subspecialties with Titan’s Enos system.

“We are pleased to report that the studies were completed on time, adding to the cadre of data supporting the Enos system’s use in pre-clinical studies. These studies provide critical input toward the final steps of development in preparation for regulatory submissions. We look forward to finalizing product development of the Enos system and continuing with our plans for application for investigational device exemption with the FDA, and once approved, proceeding with clinical studies,” stated David McNally, President and Chief Executive Officer of Titan.

About Titan Medical Inc.

Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company headquartered in Toronto, Ontario and with R&D facilities in Chapel Hill, North Carolina, is focused on enhancing robotic assisted surgery using innovative technology through a single access point. The Enos robotic single access surgical system is being developed with an ergonomic focus to provide a surgical experience that imitates real-life movements that surgeons demand, and includes multi-articulating instruments designed to allow surgeons an increased range of motion in a confined space, with dexterity and the ability to exert the forces necessary to complete common surgical tasks. With the Enos system, Titan intends to initially pursue gynecologic surgical indications. Certain of Titan’s robotic assisted surgical technologies and related intellectual property have been licensed to Medtronic plc, while retaining world-wide rights to commercialize the technologies for use with the Enos system.