TransEnterix Provides Year End Corporate Update
10 Enero 2017 - 5:50AM
Business Wire
TransEnterix, Inc. (NYSE MKT:TRXC), a medical device company
that is pioneering the use of robotics to improve minimally
invasive surgery, today provided a year-end corporate update.
“We continued to make meaningful progress during the fourth
quarter, both in terms of our commercialization efforts and in the
preparation of our Senhance 510(k) submission,” said Todd M. Pope,
President and CEO at TransEnterix. “We are excited by the
significant opportunity that lies ahead in 2017, as we look to
leverage the foundation we have put in place.”
Clinical Leadership Program
As previously announced, during the fourth quarter, the Company
launched a Clinical Leadership Program to partner with influential
institutions and surgeons in order to establish clinical reference
sites in target markets, expand the utilization of the system
across multiple procedures and specialties, and continue to
generate clinical data. On November 9, 2016, the Company announced
the first installed Senhance System as part of the Clinical
Leadership Program at Imperial College London.
Subsequent to the installment of the Senhance at Imperial
College, London, the Company has established partnerships at two
additional locations, one in Italy and one in France. The Company
expects to establish a fourth partnership during the first quarter
of 2017.
Senhance FDA Regulatory
The Company is on track to file the 510(k) for the Senhance
System in early 2017 and expects to receive clearance in late 2017.
During the fourth quarter, the Company successfully completed the
usability testing requirements for the Senhance System 510(k)
submission.
Open Platform Architecture - Visualization &
Imaging Capabilities
The Company completed the validation of two additional top-tier
vision/imaging systems for use with the Senhance System and expects
to launch this capability and related accessories during the first
quarter of 2017. Integration with third-party imaging systems
allows hospitals to leverage their existing ecosystem investments
with the Senhance System.
Robotic Training and Research & Development
Center
On December 15, 2016, the Company inaugurated the Robotic
Surgery Center in Milan, Italy. The center features an integrated
demonstration operating theater, robotic training and development
systems, and facilities for hosting large groups. This facility
also serves as the Company's European research and development
facility that will further enable research collaborations across
Europe.
Lincoln Park Capital Fund Common Stock Purchase
Agreement
On December 20, 2016, the Company announced that it has entered
into a common stock purchase agreement with Lincoln Park Capital
Fund, LLC (“Lincoln Park”). TransEnterix will have the right to
sell Lincoln Park up to $25.0 million in shares of the Company’s
common stock over a 36-month period from the date of the execution.
TransEnterix will control the timing and amount of any sales to
Lincoln Park, and Lincoln Park will be obligated to make purchases
in accordance with the stock purchase agreement. Proceeds will be
used for general corporate purposes.
Increased Equity Investment by SOFAR S.p.A
On January 5, 2017, the Company announced that it had received
an additional €5 million investment, or approximately $5.2 million,
from SOFAR S.p.A. The investment was made pursuant to an amendment
to the September 18, 2015 agreement to purchase the Senhance
technology and business operations from SOFAR. Under the amendment,
SOFAR agreed to invest in €5 million of our common stock, or
3,722,685 shares, rather than receiving an all-cash payment of €10
million due to be paid upon the company achieving certain future
milestones. The price per common share was $1.404. The remaining €5
million will be due in cash upon the completion of certain future
milestones, and may be deferred by the company to December 31, 2017
in the event that the milestone criteria is satisfied before that
date. Following this investment, SOFAR owned approximately 16.1% of
TransEnterix’ outstanding common stock.
About TransEnterix, Inc.
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
commercialization of the Senhance™ Surgical Robotic 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 sensing camera control.
The company is also developing the SurgiBot™ System, a single-port,
robotically enhanced laparoscopic surgical platform. The Senhance
Surgical Robotic System has been granted a CE Mark but is not
currently available for sale in the United States. For more
information, visit the TransEnterix website at
www.transenterix.com.
Forward-Looking Statements
This press release contains "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, which 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 establish an additional clinical leadership program site in
the 2017 first quarter, whether we will file the Senhance System
510(k) in early 2017, whether the Senhance System will receive FDA
clearance in 2017 and whether we will launch top-tier
vision/imaging systems and related accessories for use with the
Senhance System during the first quarter of 2017. We cannot assure
you that our expectations will be realized. For a discussion of the
risks and uncertainties associated with TransEnterix's business,
including those related to the regulatory approval for and
commercialization of our products, please review our filings with
the Securities and Exchange Commission (SEC), including our Annual
Report on Form 10-K filed on March 3, 2016, our most recent
periodic report on Form 10-Q, 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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version on businesswire.com: http://www.businesswire.com/news/home/20170110005362/en/
For TransEnterix, Inc.Investor Contact:Mark Klausner, +1
443-213-0501invest@transenterix.comorMedia Contact:(For EU)
Conrad Harrington, +44 (0)20 3178 8914or(For US) Hannah Dunning, +1
415-618-8750TransEnterix-SVC@sardverb.com
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