TransEnterix,
Inc. (NYSE MKT:TRXC),
a medical device company that is pioneering the use of robotics and
flexible instruments to improve minimally invasive surgery, today
announced the submission of its 510(k) application with the U.S. Food
and Drug Administration (FDA) for clearance of the company’s SurgiBot™
System.
“TransEnterix is pleased to deliver on our commitment to file for 510(k)
clearance for the SurgiBot System by mid-2015,” said TransEnterix
President and CEO, Todd M. Pope. “Robotically enhanced laparoscopy with
the SurgiBot System represents the first surgical platform designed to
address economic and clinical challenges associated with current
laparoscopic and robotic options. We view the SurgiBot as a
market-expanding technology with a compelling value for a wide variety
of surgical facilities with the potential to deliver critical benefits
to surgeons, hospitals and patients. We look forward to continuing our
preparation to bring this innovative technology to the market upon FDA
clearance.”
The SurgiBot System is the first patient-side, robotically enhanced
laparoscopy platform. Our goal is to usher in the next wave of minimally
invasive surgery by delivering excellent instrument dexterity and
precision, surgeon comfort, and minimize patient incisions. The system
is also designed to be mobile, minimize reliance on additional staff,
and be cost-effective for many types of surgical facilities.
The surgical approach and motions used with the SurgiBot are intended to
mimic established laparoscopic surgical techniques. The system utilizes
flexible instruments through articulating channels controlled directly
by the surgeon, with robotic assistance, from within the sterile field.
The flexible nature of the system allows multiple instruments to be
introduced and deployed through a single incision.
About TransEnterix
TransEnterix is a medical device company that is pioneering the use of
robotics and flexible instruments to improve minimally invasive surgery
by addressing the economic and clinical challenges associated with
current laparoscopic and robotic options. The company is focused on the
development and commercialization of the SurgiBot system, a robotically
enhanced laparoscopic surgical platform that allows the surgeon to be
patient-side within the sterile field. For more information, visit the
company’s website at www.transenterix.com.
Forward Looking Statements
This press release includes statements relating to the SurgiBot
System, and our current regulatory and commercialization plans for these
products. 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, including whether we will be able to successfully
commercialize the SurgiBot System and whether the SurgiBot System will
be able to be utilized in a wide variety of surgical facilities with the
potential to deliver critical benefits to surgeons, hospitals and
patients. Factors that could cause our results to differ materially from
those described include, but are not limited to, whether the SurgiBot
System’s 510(k) application will be cleared by the U.S. FDA. For a
discussion of the most significant 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 for the year ended December 31, 2014 filed on February 20,
2015 as amended, and other filings we make with the Securities and
Exchange Commission. 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 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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