TransEnterix, Inc., a medical device company that is pioneering the use of flexible instruments and robotics to improve minimally invasive surgery, today announced that multiple surgeons have used SurgiBot, the company’s patient-side minimally invasive robotic system, to successfully complete general surgery procedures in the porcine model. The procedures performed in the pre-clinical testing included cholecystectomy and sleeve gastrectomy.
Dr. Michel Gagner, who is president of the 2014 World Congress of the International Federation for the Surgery of Obesity & Metabolic Disorders, is among the surgeons participating in the pre-clinical testing.
“SurgiBot has promise as a patient-side robotic system for precise dissection during many types of surgical procedures,” Gagner said. “As an experienced laparoscopic surgeon, I appreciate the benefits of robotic precision, strength and ergonomics while remaining in control of the operative site in the sterile field. The system also allows the surgeon to control multiple instruments and a camera and therefore reduce reliance on other assistants during procedures.”
“We’re pleased to have achieved this important milestone in the development of SurgiBot,” said Todd M. Pope, president and CEO of TransEnterix. “We are committed to executing our plan of delivering a revolutionary patient-side robotic system to benefit patients, surgeons and hospitals.”
The company plans to submit a 510(k) application for clearance with the U.S. Food and Drug Administration for the SurgiBot system later in 2014.
The SurgiBot is a minimally invasive, patient-side robotic surgery system. The system is designed to utilize a small incision often hidden inside the belly button. SurgiBot provides multiple channels to the surgeon capable of accommodating both rigid and flexible articulating instruments which offer dexterity in complex surgical tasks. The instruments are designed to give the surgeon needed strength and precision in an ergonomically comfortable manner while maintaining tactile feel. SurgiBot also integrates high-definition, three-dimensional visualization to restore the depth perception that’s lost in traditional laparoscopic procedures. The system’s size and mobility are designed for easy repositioning during multi-quadrant surgery. As a patient-side robotic system, the surgeon maintains direct access to the sterile field throughout the procedure. By integrating the benefits of advanced technology and visualization in a patient-side surgical system, TransEnterix believes the SurgiBot will advance minimally invasive surgery for patients, surgeons and hospitals.
TransEnterix (transenterix.com) is a medical device company that is pioneering the use of flexible instruments and robotics to improve minimally invasive surgery. The company is focused on the development and commercialization of SurgiBot, a patient-side minimally invasive surgical robotic system.
Forward Looking Statements
This press release includes statements relating to our SurgiBot system and our current regulatory and commercialization plans for the 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 SurgiBot will provide precise dissection during surgical procedures, whether the SurgiBot will allow for surgeons to be in control of multiple instruments and a camera, therefore reducing the reliance on other assistants during procedures; and whether the Company will submit a 510(k) application for clearance with the U.S. FDA later in 2014. Factors that could cause our results to differ materially from those described include, but are not limited to, whether the SurgiBot’s 501(k) application will be cleared by the U.S. FDA, whether the combined company will be successful in 2014 and beyond, the pace of adoption of our product technology by surgeons, the outcome of coverage and reimbursement decisions by the government and third party payors, the success and market opportunity of our continuing and new product development efforts, including the SurgiBot system, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. 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, 2012, the Form 8-K filed on September 6, 2013 and subsequent SEC reports. 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.