Titan Medical, a medical device company focused on the design and development of surgical technologies for robotic single access surgery, 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.
Source: Titan Medical.