The company acquired the Telelap ALF-X robot-assisted surgery device from Italy’s Sofar SpA last September. The Telelap ALF-X device has CE Mark approval in the European Union for minimally invasive surgery procedures.
“We are pleased to announce the first global sale of our ALF-X System. Humanitas is an outstanding academic hospital with a respected multi-specialty surgical program. The ALF-X enables an enhanced surgical program through the use of advanced robotic technology with responsible procedural economics. The initiation of sales of ALF-X represents an important milestone towards realizing our vision to transform surgical robotics. We have made substantial progress building out our global commercial, distribution and service capabilities throughout 2016,” CEO Todd Pope said in a press release.
TransEnterix shelved its SurgiBot robot-assisted surgery device earlier this year after the FDA denied its submission for 510(k) clearance for the SurgiBot, which it claims as the 1st patient-side robotically enhanced laparoscopy platform designed to be wheeled to a patient’s bedside for single-port procedures.
In May, company executives, saying they think getting SurgiBot through the FDA would require another 510(k) submission, said they’re cutting their losses on the project and turning to the ALF-X device. TransEnterix last fall put nearly $100 million on the table for Italy’s Sofar, which developed the Telelap ALF-X and took it through CE Mark approval in the European Union.
TransEnterix CFO Joseph Slattery told analysts during a conference call that the company has already cut $4 million in annual salary costs from the SurgiBot program.
A 510(k) application for the ALF-X device is on track for later this year with FDA clearance hoped for in 2017, Slattery said. CEO Todd Pope said that, notwithstanding the company’s experience with the SurgiBot 510(k), he’s confident in the ALF-X clearance bid.