8-K

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 28, 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 28, 2020, TransEnterix, Inc., a Delaware corporation, issued a press release announcing that Kitakyushu General Hospital, a hospital in southwestern Japan, completed its first surgical procedures with the Senhance® Surgical System. TransEnterix had announced on January 29, 2020 that Kitakyushu General Hospital had entered into an agreement to lease and utilize a 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
99.1	Press Release, dated February 28, 2020

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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 28, 2020	/s/ Anthony Fernando
	Anthony Fernando
	President and Chief Executive Officer

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EX-99.1

Exhibit 99.1

TransEnterix Announces Kitakyushu General Hospital Completes First Surgical Procedures with the Senhance Surgical System

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)—Feb. 28, 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 Kitakyushu General Hospital, a hospital in southwestern Japan, completed its first surgical procedures using the Senhance^® Surgical System. The first patients were treated by Dr. Naoki Nagata, President of Kitakyushu General Hospital, and team across general and colorectal minimally invasive surgical procedures. TransEnterix had announced on January 29, 2020 that Kitakyushu General Hospital had entered into an agreement to lease and utilize a Senhance System.

“It is gratifying to see system installation, clinical training, Senhance program launch and first clinical cases completed within three weeks from signing of the agreement at Kitakyushu General Hospital and showcases the hospital’s commitment to integrating Senhance into their minimally invasive surgery program” said Anthony Fernando, president and chief executive officer at TransEnterix. “We look forward to continuing our clinical partnership with the Kitakyushu General Hospital team.”

Kitakyushu General Hospital is a prestigious institution and is recognized as one of the major hospitals in Kitakyushu. It offers both advanced and emergency medical care and is a core part of the Kitakyushu Hospital Group. It is a 360-bed facility that contains a critical care center and is the only general hospital in the Kitakyushu Hospital Group.

“We are pleased to bring this new minimally invasive surgery platform to our patients,” said Dr. Nagata. “Our Kitakyushu surgical team was able to easily and rapidly integrate the Senhance System program, progressing smoothly from installation, through staff training, to performing our first cases in a matter of weeks. The clinical partnership and comprehensive support from TransEnterix allowed us to efficiently launch this new program to our community.”

The Senhance^® System 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. It is the first new abdominal robotic surgery platform to receive FDA clearance since 2000 and is approved for use in Japan with broad reimbursement. The Senhance Surgical System was approved for use by the Japanese Ministry of Health, Labor and Welfare (MHLW) in 2019, and has the broadest procedural reimbursement of any abdominal robotic surgery platform in Japan, which applies to 98 benign and malignant laparoscopic procedures across general, colorectal, gynecologic, pediatric and urologic surgeries at reimbursement rates equivalent to traditional laparoscopy in Category A1.

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 Kitakyushu General Hospital performing first surgical procedures 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 TransEnterix’s partnering with the surgeons at Kitakyushu General Hospital will advance patient care; and whether the Senhance System will be a welcome addition to Kitakyushu General Hospital’s leading offering for patients seeking advanced minimally invasive and robotic 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, 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.

For TransEnterix, Inc.

Investor Contact:

Mark Klausner, +1 443-213-0501

or

Media Contact:

Terri Clevenger, +1 203-682-8297

XML

Cover Page	Feb. 28, 2020
Cover Page [Abstract]
Document Type	8-K
Document Period End Date	Feb. 28, 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