TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is
pioneering the use of robotics to improve minimally invasive surgery,
today announced that the Company has received an update from the FDA on
the status of the 510(k) submission for the SurgiBot™ System.
The FDA advised the Company that it has not yet concluded the review of
the Company’s 510(k) submission and provided an update on the status of
the filing. The Company has updated its timing expectations and now
expects to receive a decision from the FDA by mid-April, 2016. The
Company previously expected a decision from the FDA in the first quarter
of 2016.
“We have been engaged in constructive dialogue with the FDA throughout
the entire submission process,” said Todd M. Pope, President and Chief
Executive Officer of TransEnterix. “We appreciate the proactive exchange
with the FDA and look forward to their decision, and continue to expect
clearance for the SurgiBot.”
About TransEnterix
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 development and
commercialization of the SurgiBot™ System, a single-port, robotically
enhanced laparoscopic surgical platform, and the commercialization of
ALF-X®, 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 tracking camera control. The
SurgiBot System is not yet available for sale in any market. The ALF-X
has been granted a CE Mark but is not available for sale in the US. For
more information, visit the TransEnterix website at www.transenterix.com.
Forward Looking Statements
This press release includes statements relating to the ALF-X® System,
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 obtain SurgiBot
clearance, if at all, from the FDA by mid-April 2016; and whether we
will be able to successfully commercialize the SurgiBot System and the
ALF-X 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 March 3, 2016 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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