May 28, 2019
RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced that it 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 chief executive officer 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% 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.
About Saitama Medical University International Medical Center
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 world-class hospital. Their 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 US, the EU and select other countries. For more information, visit www.transenterix.com.
This press release includes statements relating to the current regulatory and commercialization plans for the Senhance Surgical System. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Japanese robotic surgical market will create a considerable market opportunity for the Senhance Surgical System and whether the Senhance Surgical System will allow 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. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on February 27, 2019 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.