October 01, 2018
RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–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 its Senhance Ultrasonic Instrument System.
Advanced energy devices, including ultrasonic devices, represent some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to effectively ligate and divide tissue, and minimize thermal injury to surrounding structures.
“Advanced energy devices are an important tool for laparoscopic surgeons because of their applicability within a wide range of procedures,” said Todd M. Pope, TransEnterix CEO. “We believe the addition of the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries that accept CE Mark around the world.”
“Ultrasonic energy devices are critical tools in managing complex surgeries while minimizing bleeding and trauma to surrounding tissue,” said Prof. Dietmar Stephan, M.D., Head of Minimally Invasive and Robotic Surgery at St. Marien Hospital in Siegen, Germany. “In certain procedures, use of such advanced energy has become standard of care. The addition of this capability to the Senhance Digital Laparoscopic platform is a significant expansion of clinical applicability.”
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 and select other countries. For more information, visit www.transenterix.com.
Forward Looking Statements
This press release includes statements relating to the Senhance Surgical System and the Senhance Ultrasonic Instrument System and our current regulatory and commercialization plans for this product. 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™ Ultrasonic advanced energy capability will broaden the potential applicability of Senhance surgery in CE Mark countries, whether the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries around the world that accept CE Mark, and whether the addition of the ultrasonic energy device to the Senhance Digital Laparoscopic platform is a significant expansion of Senhance’s clinical applicability. 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 filed on March 8, 2018, 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.