0001628280-20-008228.txt : 20200521 0001628280-20-008228.hdr.sgml : 20200521 20200521163054 ACCESSION NUMBER: 0001628280-20-008228 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20200521 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200521 DATE AS OF CHANGE: 20200521 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: 20902274 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-form8xk05212020si.htm 8-K Document
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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
May 21, 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 May 21, 2020, TransEnterix, Inc., a Delaware corporation, issued a press release announcing that the Sinai Health System in Chicago has entered into an agreement to lease and utilize its Senhance® Surgical System, which would be the first facility in Chicago to use the Senhance System.
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 May 21, 2020
104
Cover Page Interactive Data File (formatted in inline XBRL)





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: May 21, 2020
 
 
 
/s/ Anthony Fernando
 
 
 
 
Anthony Fernando
 
 
 
 
President and CEO


3
 EX-99.1 2 trxc-form8xkxsinaichic.htm EXHIBIT 99.1 Exhibit


Exhibit 99.1

TransEnterix Announces Sinai Health System in Chicago to Initiate Program
with the Senhance Surgical System

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--May 21, 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 Sinai Health System in Chicago has entered into an agreement to lease and utilize a Senhance® Surgical System, which would be the first facility in Chicago to move in this direction.
“Our team is excited that Sinai Health System has chosen to add the Senhance Digital Laparoscopy Platform to its minimally invasive surgery program,” said Anthony Fernando, president and chief executive officer at TransEnterix. “In the midst of the challenging times posed by COVID-19, hospitals are looking to the future and continue to seek more advanced and cost-effective technologies to treat their patients undergoing surgery. We are thrilled to partner with the excellent surgical team at Sinai Health System.”
The Senhance System is the first new abdominal robotic surgery platform to receive FDA clearance since 2000. It is the first and only digital laparoscopic surgical platform designed to maintain laparoscopic MIS standards while providing digital benefits such as haptic feedback, robotic precision, comfortable ergonomics, advanced instrumentation including, 3 mm microlaparoscopic instruments, eye sensing camera control and reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy. In March 2020, TransEnterix received FDA clearance for the first machine vision system in robotic surgery which powers the new Intelligent Surgical Unit capability of Senhance.
“We chose the Senhance Surgical System because it offers unique capabilities in adding robotics to our surgical program,” said Dr. Carlos Sandoval-Herrera FACOG, Director of Gynecology and Chief of the Division of Minimally Invasive Gynecologic Surgery at Sinai Health System. “This technology offers the opportunity to use instruments as small as 3mm with robotic assistance, which can help offer many patients virtually scarless surgery. The advances being made with augmented intelligence utilizing this system are truly the future in using digital information to better guide and control surgery.”
“As a health system, we seek to offer the best possible care utilizing the latest technology to all the patients we serve in our community, and we are proud to be the first hospital in Chicago to launch the Senhance surgical program,“ said Dr. Airica Steed, System Chief Operating Officer and Executive Vice President of Sinai Health System. “We are pleased to build upon our excellent outcomes at the Center of Excellence in Minimally Invasive Gynecological Surgery at Sinai Health System and utilize robotic surgery with Senhance to offer patients fast recovery with minimal pain and scarring.”


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 market development activities for, and increasing utilization of, its 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.

About Sinai Health System

Sinai Health System, a Chicago-based private, not-for-profit organization, is comprised of seven member organizations: Mount Sinai Hospital, Holy Cross Hospital, Sinai Children’s Hospital, Schwab Rehabilitation Hospital, Sinai Medical Group, Sinai Community Institute and Sinai Urban Health Institute. The system has over 800 physicians on its hospital medical staffs, 654 licensed beds, 100,000+ annual emergency department patient visits and eight physician residency training programs. For more information, visit www.sinai.org

Forward-Looking Statements

This press release includes statements relating to the Senhance System and the Sinai Health System in Chicago initiating a program with the Senhance System. 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 and include whether the Senhance System will provide advanced and cost-effective technologies for the patients undergoing surgery; and whether the advances being made with augmented intelligence utilizing the Senhance System will be the future in using digital information to better guide and control surgery. 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, 2019, filed with the SEC on March 16, 2020 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.

Source: TransEnterix, Inc.

For TransEnterix, Inc.
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
May 21, 2020
Cover Page [Abstract]  
Document Type 8-K
Document Period End Date May 21, 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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