UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
| Date of Report (Date of Earliest Event Reported): | September 18, 2017 |
TransEnterix, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
| Delaware | 0-19437 | 11-2962080 |
|
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
| 635 Davis Drive, Suite 300, Morrisville, North Carolina | 27560 | |
|
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
| Registrant’s telephone number, including area code: | 919-765-8400 |
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 8.01 Other Events.
On September 18, 2017, TransEnterix, Inc. (the "Company") issued a press release to disclose that it had filed its response to the U.S. Food and Drug Administration’s Additional Information request related to the Company’s Senhance Surgical Robotic System 510(k) submission. The press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press Release, dated September 18, 2017.
Exhibit Index
| Exhibit No. | Description | |
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99.1
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Press Release, dated September 18, 2017. |
Exhibit 99.1
September 18, 2017
TransEnterix, Inc. Reports Progress on Senhance FDA Submission
- Files additional information response with FDA -
- Continues to expect 510(k) clearance in 2017 -
RESEARCH TRIANGLE PARK, N.C.—(BUSINESS WIRE) — TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has filed its response to the Food and Drug Administration’s (“FDA”) Additional Information (“AI”) request related to the Company’s Senhance Surgical Robotic System 510(k) submission.
“We are very pleased to have submitted our AI response ahead of schedule, demonstrating our team’s effectiveness and our ongoing collaboration with the FDA,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “The submission of our response is a key step towards achieving 510(k) clearance for the Senhance, which we continue to expect in 2017.”
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 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 also developed 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 includes statements relating to our second quarter 2017 results, the Senhance™
Surgical Robotic System and our current regulatory and commercialization plans for this product.
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 the Senhance
510(k) will achieve clearance in 2017, if at all. 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 for the year ended December 31, 2016,
which was filed on March 6, 2017, 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.
For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
or
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com