TransEnterix Enters Next Phase of Development of SurgiBot™ System
13 Enero 2014 - 6:00AM
Business Wire
Multiple surgeons perform general surgery
procedures in pre-clinical testing
TransEnterix, Inc. (OTCBB: TRXC), a medical device company that
is pioneering the use of flexible instruments and robotics to
improve minimally invasive surgery, today announced that multiple
surgeons have used SurgiBot, the company’s patient-side minimally
invasive robotic system, to successfully complete general surgery
procedures in the porcine model. The procedures performed in the
pre-clinical testing included cholecystectomy and sleeve
gastrectomy.
Dr. Michel Gagner, who is president of the 2014 World Congress
of the International Federation for the Surgery of Obesity &
Metabolic Disorders, is among the surgeons participating in the
pre-clinical testing.
“SurgiBot has promise as a patient-side robotic system for
precise dissection during many types of surgical procedures,”
Gagner said. “As an experienced laparoscopic surgeon, I appreciate
the benefits of robotic precision, strength and ergonomics while
remaining in control of the operative site in the sterile field.
The system also allows the surgeon to control multiple instruments
and a camera and therefore reduce reliance on other assistants
during procedures.”
“We’re pleased to have achieved this important milestone in the
development of SurgiBot,” said Todd M. Pope, president and CEO of
TransEnterix. “We are committed to executing our plan of delivering
a revolutionary patient-side robotic system to benefit patients,
surgeons and hospitals.”
The company plans to submit a 510(k) application for clearance
with the U.S. Food and Drug Administration for the SurgiBot system
later in 2014.
About SurgiBot
The SurgiBot is a minimally invasive, patient-side robotic
surgery system. The system is designed to utilize a small incision
– often hidden inside the belly button. SurgiBot provides multiple
channels to the surgeon capable of accommodating both rigid and
flexible articulating instruments which offer dexterity in complex
surgical tasks. The instruments are designed to give the surgeon
needed strength and precision in an ergonomically comfortable
manner while maintaining tactile feel. SurgiBot also integrates
high-definition, three-dimensional visualization to restore the
depth perception that’s lost in traditional laparoscopic
procedures. The system’s size and mobility are designed for easy
repositioning during multi-quadrant surgery. As a patient-side
robotic system, the surgeon maintains direct access to the sterile
field throughout the procedure. By integrating the benefits of
advanced technology and visualization in a patient-side surgical
system, TransEnterix believes the SurgiBot will advance minimally
invasive surgery for patients, surgeons and hospitals.
About TransEnterix
TransEnterix is a medical device company that is pioneering the
use of flexible instruments and robotics to improve minimally
invasive surgery. The company is focused on the development and
commercialization of SurgiBot, a patient-side minimally invasive
surgical robotic system. For more information, visit the company’s
website at www.transenterix.com.
Forward Looking Statements
This press release includes statements relating to our SurgiBot
system and our current regulatory and commercialization plans for
the 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 SurgiBot will provide precise dissection during
surgical procedures, whether the SurgiBot will allow for surgeons
to be in control of multiple instruments and a camera, therefore
reducing the reliance on other assistants during procedures; and
whether the Company will submit a 510(k) application for clearance
with the U.S. FDA later in 2014. Factors that could cause our
results to differ materially from those described include, but are
not limited to, whether the SurgiBot’s 501(k) application will be
cleared by the U.S. FDA, whether the combined company will be
successful in 2014 and beyond, the pace of adoption of
our product technology by surgeons, the outcome of coverage
and reimbursement decisions by the government and third party
payors, the success and market opportunity of our continuing and
new product development efforts, including the SurgiBot system, the
effect on our business of existing and new regulatory requirements,
and other economic and competitive factors. 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,
2012, the Form 8-K filed on September 6, 2013 and
subsequent SEC reports. 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.
Investor Contact:Westwicke PartnersMark Klausner,
443-213-0501transenterix@westwicke.comorMedia Contact:Karen
Stinneford, 919-833-9102
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