TransEnterix Receives Japanese Regulatory Approval of the Senhance Surgical System

TransEnterix Inc., a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, has received Japanese regulatory approval for the Senhance Surgical System.
 
“Regulatory approval in Japan is a pivotal milestone for our company, as Japan is second only to the U.S. as the world’s largest surgical robotics market,” said Todd M. Pope, president and CEO of TransEnterix. “Japan’s high penetration of laparoscopic surgery coupled with their rapid adoption of robotics and the intense focus on procedure cost creates a considerable market opportunity for Senhance.”
 
The Senhance Surgical System was approved (Shonin) by the Ministry of Health, Labor and Welfare (MHLW) for use in laparoscopy for general surgery, gynecology, urology and certain thoracic procedures.
 
“Approval of the Senhance Surgical System for use in laparoscopic procedures in Japan is a major achievement,” said Professor Shigeki Yamaguchi, M.D., Ph.D., chief of Colorectal Surgery at Saitama Medical University International Medical Center. “As the first hospital in Japan to obtain and utilize the Senhance Surgical System to treat patients, I believe this technology allows surgeons to offer excellent minimally invasive procedures that add precision and visual control while leveraging a familiar laparoscopic approach with minimal additional costs to the health system.”
 
Japan is the second-largest medical device market in the world, valued at over $40 billion annually, including over $5 billion in capital equipment spending. There are more than 8,400 hospitals in Japan, of which approximately 80 percent are private entities. Japanese laparoscopic penetration in surgery is among the highest in the world. The central government has implemented cost containment initiatives in recent years and has approached recent procedure approvals for robotics by establishing reimbursement at the same rate as traditional laparoscopy, which places a high emphasis on procedure cost to influence adoption.
 
Saitama Medical University International Medical Center was established in April 2007 with the objective of contributing to regional and Japanese medicine, aiming to create an internationally competitive hospital. Its mission is to cover all areas of Saitama prefecture, to be dedicated in highly specialized medical service for cancer and heart disease, and to provide advanced critical and emergency medical care. The medical center is affiliated with Saitama Medical University Medical Hospital, and is one of the top-ranked hospitals in Japan. Saitama Medical University International Medical Center is the first university hospital in Japan to be Joint Commission International (JCI) accredited.
 
TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the United States, the European Union and select other countries.