FDA Approved: Transenterix Inc (TRXC) Will Now Offer Surgical Robotic System in the US


trxcTransenterix Inc (NYSEAMERICAN:TRXC) investors are overwhelmingly excited today after the medical device maker announced the Company has received FDA 510(k) clearance for the Senhance™ Surgical Robotic System.

Transenterix shares reacted to the news, skyrocketing nearly 85% to $2.72 in Monday’s trading session.

TransEnterix CEO Todd M. Pope commented, “The clearance of the Senhance System in the US is a milestone in the progress of robotics and is expected to deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals […] Millions of surgical procedures in the US are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control. New choices are needed that enhance the senses, control and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize value for the hospital. Senhance is this new choice.”

With this clearance, the Senhance becomes the first new market entrant into the field of abdominal surgical robotics since 2000. Using the system, a surgeon directs small surgical instruments and a camera with precise movements and comfort. The system builds on the foundation of laparoscopy and features the security of haptic feedback and eye-sensing camera control for the first time in a robotic surgery platform. Additionally, the Senhance utilizes an open architecture, which allows hospitals and surgeons to leverage existing technology investments within the operating room ecosystem. The system is specifically engineered to manage operative costs effectively, making robotic surgery cost-effective on a per-procedure basis through the use of fully reusable instruments.

“Surgeons are approaching the boundaries of minimally invasive care performed with handheld manual instruments and cameras, and are seeking new technologies that will allow us to advance beyond these boundaries,” said Dr. Steve Eubanks, a general surgeon and Executive Director of Academic Surgery at Florida Hospital. “The future will be driven by the appropriate use of robotics and information tools in the operating room. The Senhance platform grants laparoscopic surgeons robotic precision, control of our vision, and haptic feedback while minimizing procedural costs, and is a welcome revolution in our field.”

TransEnterix operates as a development stage medical device company. It focuses on research, development and sale of medical device robotics to improve minimally invasive surgery. It offers the Senhance Surgical Robotic System, which offers robotic surgery for laparoscopic abdominal and pelvic surgery, as well as limited thoracic operations excluding cardiac and vascular surgery, and the SurgiBot System which refers to the a single-port, robotically enhanced laparoscopic surgical platform.