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): | December 19, 2014 |
TransEnterix, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
| Delaware | 0-19437 | 11-2962080 |
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_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
| 635 Davis Drive, Suite 300, Morrisville, North Carolina | 27560 | |
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_________________________________ (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))
Item 8.01 Other Events.
On December 19, 2014, TransEnterix, Inc. (the "Company"), announced the successful completion of four general surgery and urology lab procedures as part of its development activities for its SurgiBot system, a minimally invasive, patient-side robotic surgery system current in development. TransEnterix also affirmed its prior guidance of its intent to submit a 510(k) filing for the SurgiBot system in mid-2015. A copy of the press release is attached to this Form 8-K as Exhibit 99.1 and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. Description
99.1 TransEnterix, Inc. press release, issued December 19, 2014.
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 hereunto duly authorized.
| TransEnterix, Inc. | ||||
| December 19, 2014 | By: |
Joseph P. Slattery
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| Name: Joseph P. Slattery | ||||
| Title: EVP and CFO | ||||
Exhibit Index
| Exhibit No. | Description | |
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99.1
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TransEnterix, Inc. press release, issued December 19, 2014 |
Exhibit 99.1
TransEnterix Completes Successful Pre-Clinical Robotic Surgical Procedures; Management Affirms
FDA Timeline
- SurgiBotTM system FDA 510(k) filing on track for mid-2015 submission -
December 19, 2014
RESEARCH TRIANGLE PARK, N.C.—(BUSINESS WIRE)— TransEnterix, Inc. (NYSE MKT:
TRXC), a medical device company that is pioneering the use of robotics and flexible
instruments to improve minimally invasive surgery, today announced the successful completion of
four general surgery and urology procedures using its SurgiBot system patient-side robotic surgery
system. Management also stated that the preparation of its FDA 510(k) filing is proceeding as
planned, and affirmed prior guidance of its intention to submit the filing in mid-2015.
Using the SurgiBot system in the porcine model, Dr. Juan-Carlos Verdeja, a general surgeon and Chief of General Surgery at Baptist Health Medical Group in Miami, performed two cholecystectomy (gallbladder removal) procedures, and Dr. Michael N. Ferrandino, a urologist and Director of Minimally Invasive Urologic Surgery at the Duke Division of Urology, performed two nephrectomy (kidney removal) procedures.
“The SurgiBot system has the ability to offer multiple instruments and a camera through a single small incision. It is designed to limit surgical trauma while enabling the surgeon with advanced vision, dexterity and control,” said Dr. Verdeja. “I was impressed with the system’s capabilities, providing ergonomic benefits as well as excellent visualization in 3DHD. Being able to perform the procedure from within the sterile field, and with tactile feedback, increases the control a surgeon has when performing surgery.”
Dr. Ferrandino commented, “I can envision the SurgiBot being utilized in a wide variety of surgical procedures. This system provides an elegant and effective combination of the best of single-port, laparoscopic and robotic approaches in surgery.”
“These pre-clinical procedures support our expectation for commercial success with the SurgiBot,” said Todd M. Pope, president and CEO of TransEnterix. “We are pleased with our progress and our FDA 510(k) filing remains on track for a mid-2015 submission.”
About SurgiBot
The SurgiBot system, currently in development, is a minimally invasive, patient-side robotic surgery system. The system utilizes flexible instruments through articulating channels controlled directly by the surgeon, with robotic assistance, at the patient’s bedside. The flexible nature of the system allows for multiple instruments to be introduced and deployed through a single incision. The SurgiBot system has not been cleared by the FDA for use the in United States.
About TransEnterix
TransEnterix is a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery. The company is focused on the development and commercialization of the SurgiBot system, a minimally invasive surgical robotic system that allows the surgeon to be patient-side within the sterile field. For more information, visit the company’s website at www.transenterix.com.
Forward Looking Statements
This press release includes statements relating to the SurgiBot system, our flexible energy device
and our current regulatory and commercialization plans for these products. 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 we will successfully submit our
SurgiBot system regulatory filings in mid-2015, whether we will be able to successfully
commercialize the SurgiBot system and whether the SurgiBot system will be able to be utilized in a
wide variety of procedures. Factors that could cause our results to differ materially from those
described include, but are not limited to, whether the SurgiBot system’s 510(k) application(s) will
be cleared by the U.S. FDA. For a discussion of the most significant 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, 2013
filed on March 5, 2014 as amended, and other filings we make with the Securities and Exchange
Commission. 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
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:
Westwicke Partners
Mark Klausner, 443-213-0501
transenterix@westwicke.com
Media Contact:
TransEnterix, Inc.
Mohan Nathan, 919-917-6559
mnathan@transenterix.com