Stock prices for the Research Triangle Park, N.C.-based plunged last month when TransEnterix revealed that 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.
Yesterday 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 yesterday that the company has already cut $4 million in annual salary costs from the SurgiBot program.
“Many of our home office R&D and regulatory personnel will continue in new roles focusing on the ALF-X 510(k) and continuing ALF-X development activities, while, overseas, our headcount another investment plans remain unchanged as we continue our focus on supporting revenue growth and advancing the platform,” Slattery said, according to Seeking Alpha.
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.
“So I think we’re a little smarter now,” Pope said. “We certainly think we are better-positioned. First of all, the ALF-X has CE Mark, had that for several years. We’ve got clinical data. We’ve got several systems out in clinical use. We have multiple publications from multiple specialties. So we just think we are going in to the ALF-X filing in a different and stronger position than we were with SurgiBot.”
Pope said TransEnterix, which has added 3 direct sales reps since March, plans to recruit “a senior leader on from the surgical community” for the ALF-X team.
“It is early days for us as we go out and start establishing our commercial organization. We are excited about the folks we brought in. We’re bringing them in from great companies, both robotic companies and large-cap medtech, so they’ve got a good working knowledge of Europe,” he said.
The company said it pared losses by -9.9% to -%9.1 million during the 1st quarter, although earnings per share slid -25.0% to -12¢ compared with Q1 2015.
TRXC shares closed down -6.4% at $2.06 apiece yesterday and plunged another -15.1% to $1.75 in pre-market trading today.