RESEARCH TRIANGLE PARK, N.C.--(EON: Enhanced Online News)--TransEnterix, Inc. (NYSE MKT:TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today provided a year-end corporate update.
“We continued to make meaningful progress during the fourth quarter, both in terms of our commercialization efforts and in the preparation of our Senhance 510(k) submission”
“We continued to make meaningful progress during the fourth quarter, both in terms of our commercialization efforts and in the preparation of our Senhance 510(k) submission,” said Todd M. Pope, President and CEO at TransEnterix. “We are excited by the significant opportunity that lies ahead in 2017, as we look to leverage the foundation we have put in place.”
Clinical Leadership Program
As previously announced, during the fourth quarter, the Company launched a Clinical Leadership Program to partner with influential institutions and surgeons in order to establish clinical reference sites in target markets, expand the utilization of the system across multiple procedures and specialties, and continue to generate clinical data. On November 9, 2016, the Company announced the first installed Senhance System as part of the Clinical Leadership Program at Imperial College London.
Subsequent to the installment of the Senhance at Imperial College, London, the Company has established partnerships at two additional locations, one in Italy and one in France. The Company expects to establish a fourth partnership during the first quarter of 2017.
Senhance FDA Regulatory
The Company is on track to file the 510(k) for the Senhance System in early 2017 and expects to receive clearance in late 2017. During the fourth quarter, the Company successfully completed the usability testing requirements for the Senhance System 510(k) submission.
Open Platform Architecture - Visualization & Imaging Capabilities
The Company completed the validation of two additional top-tier vision/imaging systems for use with the Senhance System and expects to launch this capability and related accessories during the first quarter of 2017. Integration with third-party imaging systems allows hospitals to leverage their existing ecosystem investments with the Senhance System.
Robotic Training and Research & Development Center
On December 15, 2016, the Company inaugurated the Robotic Surgery Center in Milan, Italy. The center features an integrated demonstration operating theater, robotic training and development systems, and facilities for hosting large groups. This facility also serves as the Company's European research and development facility that will further enable research collaborations across Europe.
Lincoln Park Capital Fund Common Stock Purchase Agreement
On December 20, 2016, the Company announced that it has entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). TransEnterix will have the right to sell Lincoln Park up to $25.0 million in shares of the Company’s common stock over a 36-month period from the date of the execution. TransEnterix will control the timing and amount of any sales to Lincoln Park, and Lincoln Park will be obligated to make purchases in accordance with the stock purchase agreement. Proceeds will be used for general corporate purposes.
Increased Equity Investment by SOFAR S.p.A
On January 5, 2017, the Company announced that it had received an additional €5 million investment, or approximately $5.2 million, from SOFAR S.p.A. The investment was made pursuant to an amendment to the September 18, 2015 agreement to purchase the Senhance technology and business operations from SOFAR. Under the amendment, SOFAR agreed to invest in €5 million of our common stock, or 3,722,685 shares, rather than receiving an all-cash payment of €10 million due to be paid upon the company achieving certain future milestones. The price per common share was $1.404. The remaining €5 million will be due in cash upon the completion of certain future milestones, and may be deferred by the company to December 31, 2017 in the event that the milestone criteria is satisfied before that date. Following this investment, SOFAR owned approximately 16.1% of TransEnterix’ outstanding common stock.
About TransEnterix, Inc.
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 is also developing 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.
This press release contains "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, which 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 establish an additional clinical leadership program site in the 2017 first quarter, whether we will file the Senhance System 510(k) in early 2017, whether the Senhance System will receive FDA clearance in 2017 and whether we will launch top-tier vision/imaging systems and related accessories for use with the Senhance System during the first quarter of 2017. We cannot assure you that our expectations will be realized. For a discussion of the risks and uncertainties associated with TransEnterix's business, including those related to the regulatory approval for and commercialization of our products, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 3, 2016, our most recent periodic report on Form 10-Q, 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.