- Continue to anticipate SurgiBot FDA clearance by the end of the
first quarter of 2016 -
- Strengthens balance sheet with $18M of equity raised -
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 following:
-
Completes FDA Response. TransEnterix has successfully completed
its response to the U.S. Food and Drug Administration (FDA) related to
the pending 510(k) application submitted for clearance of the
company’s SurgiBot™ System.
-
Strengthens Balance Sheet. Since September 30, 2015, the
Company has raised $18 million(1) in net proceeds at an
average price of $3.23 per share under its $25 million “at-the-market”
(ATM) equity sales facility that was established in February 2015.
There is no further availability under this facility. The proceeds
from these sales will be utilized to continue to support investments
for the commercialization of the ALF-X® system in Europe, as well as
the SurgiBot in the United States, following FDA clearance.
-
Files New ATM Facility. Following the successful completion of
the prior ATM facility, the Company has entered into a new ATM
facility that allows it the option to raise up to $43.6 million in
equity from time to time through January 2017. The Company has no
obligation to sell any shares under this facility.
“We are pleased to have completed our response to the FDA and
strengthened our balance sheet,” said TransEnterix President and CEO,
Todd M. Pope. “We continue to expect FDA clearance for the SurgiBot
System in the first quarter of this year, and our cash position allows
us to accelerate our transition to commercializing both the ALF-X and
the SurgiBot.”
(1)Includes trades that have been processed but not yet
settled as of the date of this press release.
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 SurgiBot System,
the ALF-X® 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 achieve clearance for the
SurgiBot System from the FDA in the first quarter of this year and
whether our cash position allows us to accelerate our transition to
commercializing both the ALF-X and the SurgiBot. 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 Quarterly Report on Form 10-Q filed on
November 9, 2015 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160210005524/en/
Copyright Business Wire 2016