0001628280-20-001389.txt : 20200212 0001628280-20-001389.hdr.sgml : 20200212 20200212065536 ACCESSION NUMBER: 0001628280-20-001389 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20200212 ITEM INFORMATION: Other Events FILED AS OF DATE: 20200212 DATE AS OF CHANGE: 20200212 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRANSENTERIX, INC. CENTRAL INDEX KEY: 0000876378 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 112962080 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19437 FILM NUMBER: 20599678 BUSINESS ADDRESS: STREET 1: 635 DAVIS DRIVE STREET 2: SUITE 300 CITY: MORRISVILLE STATE: NC ZIP: 27560 BUSINESS PHONE: 919-765-8400 MAIL ADDRESS: STREET 1: 635 DAVIS DRIVE STREET 2: SUITE 300 CITY: MORRISVILLE STATE: NC ZIP: 27560 FORMER COMPANY: FORMER CONFORMED NAME: TRANSENTERIX INC. DATE OF NAME CHANGE: 20131210 FORMER COMPANY: FORMER CONFORMED NAME: SafeStitch Medical, Inc. DATE OF NAME CHANGE: 20080211 FORMER COMPANY: FORMER CONFORMED NAME: CELLULAR TECHNICAL SERVICES CO INC DATE OF NAME CHANGE: 19930328 8-K 1 trxc-form8xkxpressrele.htm 8-K Document
false0000876378 0000876378 2020-02-12 2020-02-12


    
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
February 12, 2020
Date of Report (date of earliest event reported)
_________________
TransEnterix, Inc.
(Exact name of Registrant as specified in its charter)
_________________
Delaware
 
0-19437
 
11-2962080
(State or other jurisdiction of incorporation or organization)
 
(Commission
File Number)
 
(I.R.S. Employer
Identification Number)

635 Davis Drive, Suite 300
Morrisville, North Carolina 27560
(Address of principal executive offices)
919-765-8400
(Registrant’s telephone number, including area code)
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 (see General Instruction A.2. below):
☐ 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))
Securities registered pursuant to Section 12(b) of the Act:

Title of each class
 
Trading symbol
 
Name of each exchange on which registered
Common Stock
$0.001 par value per share
 
TRXC
 
NYSE American

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 February 12, 2020, TransEnterix, Inc., a Delaware corporation, issued a press release announcing that its Senhance® Surgical System received CE Mark for use in pediatric indications.
A copy of the press release is filed herewith as Exhibit 99.1 and incorporated herein by reference.


Item 9.01    Financial Statements and Exhibits.
(d) Exhibits.
Exhibit   No.  
Description
Press Release, dated February 12, 2020





2



SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
 
 
 
 
 
 
 
 
 
 
TransEnterix, Inc.
 
 
 
Date: February 12, 2020
 
 
 
/s/ Brett Farabaugh
 
 
 
 
Brett Farabaugh
 
 
 
 
Interim Chief Financial Officer


3
 EX-99.1 2 exhibit991-pediatric.htm EXHIBIT 99.1 Exhibit

Exhibit 99.1


TransEnterix Announces CE Mark Approval for Pediatric Indication for Senhance Surgical System
TransEnterix is First to Offer Robotic 3 mm Microlaparoscopic Surgery for Pediatric Patients

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Feb. 12, 2020-- TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company received CE Mark approval for an expanded indication to treat pediatric patients above 10kg (approximately 22 lbs) with the Senhance® System.

“Given the size of the patients, pediatric surgery seeks to use the smallest instruments and scopes possible to minimize invasiveness, yet it is critical to maintain a high degree of precision,” said Anthony Fernando, president and chief executive officer of TransEnterix. “The Senhance System is designed to maximize control of instruments as small as 3 mm and be compatible with small scopes while also retaining the sense of touch through haptic feedback. This makes our technology uniquely positioned to meet the requirements of pediatric surgeons, and we look forward to working closely with leading European hospitals to serve the needs of their pediatric patients.”

“The ability to use 3 mm microlaparoscopic instruments on a robotic platform is very exciting and is a large step forward in treating pediatric patients,” said Prof. Dr. Wim van Gemert, chairman of the department of pediatric surgery, Maastricht University Medical Center+ in the Netherlands. “Especially in younger patients, smaller ports and instruments are critically important in achieving the best outcomes given the body size constraints in these patients.”

The Senhance® Surgical System is the first and only digital laparoscopic platform designed to maintain laparoscopic MIS standards while providing digital benefits such as haptic feedback, robotic precision, eye-sensing camera control, comfortable ergonomics, advanced instrumentation including, 3 mm microlaparoscopic instruments, eye-sensing camera control and reusable standard instruments to help maintaining per-procedure costs similar to traditional laparoscopy.

Senhance European Indication for Use
The Senhance® Surgical System has received a CE Mark according to the Medical Device Directive and is intended to be used for laparoscopic surgery in the abdomen, pelvis and limited uses in the thoracic cavity excluding the heart and greater vessels. The system is indicated for adult and pediatric use in CE marked territories.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today's value-based healthcare environment. The Company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU, Japan and select other countries. For more information, visit www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the Senhance System and the expansion of indications to include pediatric applications in CE marked territories. 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 indication expansion to treat pediatric patients will broaden our Senhance footprint in CE countries and whether the Senhance System technology is uniquely positioned to meet the requirement of pediatric surgeons. 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, 2018, filed with the SEC on February 27, 2019 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.

Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media Contact:
Terri Clevenger, +1 203-682-8297
terri.clevenger@icrinc.com


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Cover Page
Feb. 12, 2020
Cover Page [Abstract]  
Document Type 8-K
Document Period End Date Feb. 12, 2020
Entity Registrant Name TransEnterix, Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 0-19437
Entity Tax Identification Number 11-2962080
Entity Address, Address Line One 635 Davis Drive
Entity Address, Address Line Two Suite 300
Entity Address, City or Town Morrisville
Entity Address, State or Province NC
Entity Address, Postal Zip Code 27560
City Area Code 919
Local Phone Number 765-8400
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock$0.001 par value per share
Trading Symbol TRXC
Security Exchange Name NYSEAMER
Entity Emerging Growth Company false
Entity Central Index Key 0000876378
Amendment Flag false
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