TransEnterix, Inc. (NYSE MKT:TRXC) today announced that the United
States Food and Drug Administration (“FDA”) notified the Company on
April 19, 2016 that the FDA has determined that the SurgiBot™ System
does not meet the criteria for substantial equivalence based upon the
data and information submitted by TransEnterix in its 510(k) submission.
“The FDA’s decision is extremely disappointing. We are in the process of
reviewing all aspects of the FDA’s communication,” said Todd M. Pope,
President and CEO of TransEnterix. “We will work to complete this
review, and will provide an update on the regulatory strategy for the
SurgiBot System together with our first quarter 2016 financial and
operating results during our quarterly conference call on May 10, 2016.”
First Quarter Financial and Operating Results Conference Call
TransEnterix will release first quarter 2016 financial and operating
results after the market closes on Tuesday, May 10, 2016. Todd M. Pope,
President & Chief Executive Officer and Joseph P. Slattery, Executive
Vice President and Chief Financial Officer will host a conference call
to discuss these results starting at 4:30 pm Eastern Time the same day.
The call will be concurrently webcast.
To listen to the conference call on your telephone, please dial,
888-427-9419 for domestic callers and 719-457-1035 for international
callers and reference TransEnterix Call approximately ten minutes prior
to the start time. 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.
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 ALF-X®
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 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 U.S. For
more information, visit TransEnterix online 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. 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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