Today Titan Medical Inc. announced the successful completion of the chronic procedures performed under Good Laboratory Practice (“GLP”) principles using its single-port robotic surgery system, noting that all animals survived through the follow-up period. Ricardo Estape, M.D., a robotic gynecologic oncology surgeon specializing in robotic single incision surgeries from South Miami Gynecology Oncology Group, led the completion of the GLP studies.
The Company now intends to complete the full GLP studies report and required Summative Human Factors studies, followed by the full Human Factors Evaluation (“HFE”) report to facilitate filing of the Investigational Device Exemption (“IDE”) submission by the end of September.
“We are pleased to have successfully completed the survival phase of the chronic studies performed under the expert guidance of Dr. Estape for our IDE application to the U.S. Food and Drug Administration (“FDA”),” said David McNally, Titan’s chief executive officer. “All of the chronic study animals survived the required time following benign hysterectomy procedures using our single-port robotic surgery system. The demonstration of multi-week survival is a significant achievement for Titan. We are encouraged by the results and our team is now focused on completing the remaining milestones to support a 510(k) filing by year-end 2019.”
Dr. Estape said, “It was a privilege to lead these important studies with Titan’s single-port robotic surgery system and I am pleased that the post-surgery period has elapsed without complications. The survival of the chronic animals, along with the successful completion of other GLP acute animal and cadaver studies, demonstrates that I was able to complete the essential surgical tasks to achieve the desired results using the system. I remain very excited about the potential of Titan’s single-port robotic surgical system. Once cleared for clinical use, it may deliver single-incision surgery performance that could result in reduced trauma and faster healing for my patients.”