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.
About TransEnterix
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.
Forward-Looking Statements
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.
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