RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
TransEnterix, Inc. (NYSE American: TRXC), a medical device company that
is pioneering the use of robotics to improve minimally invasive surgery,
today announced the Company has received FDA 510(k) clearance for the
Senhance™ Surgical Robotic System.
"The clearance of the Senhance System in the US is a milestone in the
progress of robotics and is expected to deliver improvement in the
efficacy, value and choices offered to patients, surgeons and
hospitals," said Todd M. Pope, President and Chief Executive Officer of
TransEnterix. "Millions of surgical procedures in the US are performed
each year laparoscopically with basic manual tools that limit surgeons'
capability, comfort and control. New choices are needed that enhance the
senses, control and comfort of the surgeon, minimize the invasiveness of
surgery for the patient, and maximize value for the hospital. Senhance
is this new choice."
With this clearance, the Senhance becomes the first new market entrant
into the field of abdominal surgical robotics since 2000. Using the
system, a surgeon directs small surgical instruments and a camera with
precise movements and comfort. The system builds on the foundation of
laparoscopy and features the security of haptic feedback and eye-sensing
camera control for the first time in a robotic surgery platform.
Additionally, the Senhance utilizes an open architecture, which allows
hospitals and surgeons to leverage existing technology investments
within the operating room ecosystem. The system is specifically
engineered to manage operative costs effectively, making robotic surgery
cost-effective on a per-procedure basis through the use of fully
"Surgeons are approaching the boundaries of minimally invasive care
performed with handheld manual instruments and cameras, and are seeking
new technologies that will allow us to advance beyond these boundaries,"
said Dr. Steve Eubanks, a general surgeon and Executive Director of
Academic Surgery at Florida Hospital. "The future will be driven by the
appropriate use of robotics and information tools in the operating room.
The Senhance platform grants laparoscopic surgeons robotic precision,
control of our vision, and haptic feedback while minimizing procedural
costs, and is a welcome revolution in our field."
TransEnterix will host a conference call on Tuesday, October 17, 2017 at
8:00 AM ET to discuss the FDA clearance of the Senhance. To listen to
the conference call on your telephone, please dial (844) 804-5261 for
domestic callers or (612) 979-9885 for international callers, reference
conference code 1546349. To access the live audio webcast or archived
recording, use the following link http://ir.transenterix.com/events.cfm.
The replay will be available on the Company's website.
TransEnterix is a medical device company that is pioneering the use of
robotics to improve minimally invasive surgery by addressing the
clinical and economic challenges associated with current laparoscopic
and robotic options. The Company is focused on the commercialization of
the Senhance™ Surgical Robotic System, a multi-port robotic system that
brings the advantages of robotic surgery to patients while enabling
surgeons with innovative technology such as haptic feedback and eye
sensing camera control. The Company also developed the SurgiBot™ System,
a single-port, robotically enhanced laparoscopic surgical platform. The
Senhance Surgical Robotic System has received FDA 510(k) clearance and
has been granted a CE Mark. For more information, visit the TransEnterix
website at www.transenterix.com.
This press release includes statements relating to the Senhance™
Surgical Robotic System and our current regulatory and commercialization
plans for this product. 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 Senhance Surgical Robot will
deliver improvement in the efficacy, value and choices offered to
patients, surgeons and hospitals, whether the Senhance System will
maximize value for hospitals and whether the Senhance platform grants
laparoscopic surgeons robotic precision, control of surgeon's vision and
haptic feedback while minimizing procedural costs. 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 March 7, 2017
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171013005683/en/
For TransEnterix, Inc.
Mohan Nathan, +1-919-765-8400
Source: TransEnterix, Inc.
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