Stock of RTP-based TransEnterix Rises 225 Percent After FDA Clearance

TransEnterix Inc., a medical device company, has seen its stock price rise by more than 225 percent in the last two days after receiving U.S. Food and Drug Administration clearance of its Senhance Surgical Robotic System.

TransEnterix stock rose 92 percent, rising from $1.46 on Friday to $2.81 on Monday, after the company issued a press release announcing the FDA approval.

The stock rose as much as 71 percent again during Tuesday morning trading and now sits at $4.82. The stock is now up 226 percent during the last two days.

The Senhance Surgical Robotic System is the first new entrant into the market of abdominal surgical robotics since 2000.

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, said Todd M. Pope, president and chief executive officer of TransEnterix, in a press release.

“Millions of surgical procedures in the U.S. are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control,” said Pope. “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.”

Transenterix had filed for approval with the FDA in April and then filed additional information in September.

“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.”

TransEnterix, which was founded in 2005, aims to use robotics to improve minimally invasive surgery by addressing the clinical and economic challenges currently associated with laparoscopic and robotic options, according to their website.

In August, TransEnterix announced that it installed a Senhance Surgical Robot at the Institute for Surgical Advancement at Florida Hospital Orlando.

The Institute for Surgical Advancement is the first U.S. center to explore the new surgical robotic platform. TransEnterix now has Senhance systems in hospitals in France, Germany, Italy, Japan, the United Kingdom and the United States.

TransEnterix also developed the SurgiBot System, a robotically enhanced laparoscopic surgical platform.

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