Post by icemandios on Feb 10, 2016 14:00:34 GMT
TransEnterix Finalizes FDA Submission Process Related to SurgiBot System 510(k) Application
- Continue to anticipate SurgiBot FDA clearance by the end of the first quarter of 2016 -
- Strengthens balance sheet with $18M of equity raised -
TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the following:
Completes FDA Response. TransEnterix has successfully completed its response to the U.S. Food and Drug Administration (FDA) related to the pending 510(k) application submitted for clearance of the company’s SurgiBot™ System.
Strengthens Balance Sheet. Since September 30, 2015, the Company has raised $18 million(1) in net proceeds at an average price of $3.23 per share under its $25 million “at-the-market” (ATM) equity sales facility that was established in February 2015. There is no further availability under this facility. The proceeds from these sales will be utilized to continue to support investments for the commercialization of the ALF-X® system in Europe, as well as the SurgiBot in the United States, following FDA clearance.
Files New ATM Facility. Following the successful completion of the prior ATM facility, the Company has entered into a new ATM facility that allows it the option to raise up to $43.6 million in equity from time to time through January 2017. The Company has no obligation to sell any shares under this facility.
“We are pleased to have completed our response to the FDA and strengthened our balance sheet,” said TransEnterix President and CEO, Todd M. Pope. “We continue to expect FDA clearance for the SurgiBot System in the first quarter of this year, and our cash position allows us to accelerate our transition to commercializing both the ALF-X and the SurgiBot.”
(1)Includes trades that have been processed but not yet settled as of the date of this press release.
About TransEnterix
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 development and commercialization of the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform, and the commercialization of ALF-X®, 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 tracking camera control. The SurgiBot System is not yet available for sale in any market. The ALF-X has been granted a CE Mark but is not available for sale in the US. For more information, visit the TransEnterix website at www.transenterix.com.
