TransEnterix Announces Completion of GLP Studies
16 Abril 2015 - 3:15PM
Business Wire
SurgiBotTM system FDA 510(k)
filing on track for mid-2015 submission
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 successful
completion of its GLP Studies using the SurgiBot system, its
patient-side robotic surgery system. Management also commented that
the Company remains on track to submit its FDA 510(k) filing in
mid-2015.
“We are pleased to have completed our GLP Studies, one of the
key remaining steps prior to the upcoming 510(k) submission for the
SurgiBot system. Our GLP studies included multiple procedures
performed by surgeons from varying specialties to demonstrate the
system’s ability to handle the critical tasks commonly performed in
laparoscopy,” said Todd M. Pope, President and Chief Executive
Officer of TransEnterix. “Importantly, we continue to be in
position for a mid-2015 submission.”
Dr. Michel Gagner of Montreal, Canada and President of the 2014
World Congress of the International Federation for the Surgery of
Obesity & Metabolic Disorders was one of the investigators for
the study. “The SurgiBot system proved to be capable of effectively
performing surgery in this completed study,” said Dr. Gagner. “The
system provided articulating vision and multiple instruments
through a single incision. The user experience keeps the surgeon in
the sterile field with familiar laparoscopic movement. I prefer to
be at the patient’s side during surgery, and appreciate maintaining
the approach and movement of gold standard laparoscopic surgery
while adding the features of robotic assistance.”
Analyst Event
The Company will host an Analyst Event featuring an expert panel
of laparoscopic surgeons at 10:00am CT / 11:00am ET on Friday,
April 17, 2015. The event will take place at the Gaylord Opryland
Resort and Convention Center in Nashville, TN, and a live webcast
will be accessible using the following link:
http://ir.transenterix.com/events.cfm. A replay will be available
on the company’s website.
About SurgiBot
The SurgiBot system, currently in development, is a minimally
invasive, patient-side robotic surgery system. The system utilizes
flexible instruments through articulating channels controlled
directly by the surgeon, with robotic assistance, at the patient’s
bedside. The flexible nature of the system allows for multiple
instruments to be introduced and deployed through a single
incision. The SurgiBot system has not been cleared by the FDA for
use the in United States.
About TransEnterix
TransEnterix is a medical device company that is pioneering the
use of robotics and flexible instruments to improve minimally
invasive surgery. The company is focused on the development and
commercialization of the SurgiBot system, a minimally invasive
surgical robotic system 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, our flexible energy device 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 successfully submit our
SurgiBot system regulatory filings in mid-2015, 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 procedures. 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(s) 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.
Investor Contact:Westwicke PartnersMark Klausner,
443-213-0501transenterix@westwicke.comorMedia
Contact:TransEnterix, Inc.Mohan Nathan,
919-917-6559mnathan@transenterix.com
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