more closely resemble traditional laparoscopic surgery, which reduces both the learning curve for surgeons and the hospital’s expenses for robotic surgery. TransEnterix expects that per procedure, robotic surgeries using its devices will be comparable in cost to traditional laparoscopic surgery. Laparoscopic surgery is the dominant form of minimally invasive surgery, accounting for more than 6 million procedures in the United States and in CE Mark countries, according to figures TransEnterix cited from the Millenium Research Group. [Paragraph updated with details from the conference call.]
The ALF-X was granted Europe’s CE Mark in 2012, clearing the product for use in general surgery, gynecology, urology, and thoracic procedures. It is not cleared for use in the United States. TransEnterix says both robotic systems are designed to provide surgeons a better sense of touch during surgery, while keeping the surgeon close to the surgical field.
TransEnterix CFO Joe Slattery said that ALF-X gives TransEnterix a ready-for-market product that accelerates the timeline for generating surgical robotics revenue, and also increases that revenue opportunity. The company last month named Paul Ziegler the company’s vice president of sales, hiring him away from Intuitive Surgical. Pope said that Ziegler’s role will remain focused on SurgiBot sales in the United States; the company will be making additional hires to support international sales of ALF-X. But he added that TransEnterix will also be going to market through distributors and partners using global relationships that the company established when it first commercialized the SPIDER. [Paragraph added to include comments from the conference call.]
The FDA has asked TransEnterix for more information about the SurgiBot as the agency considers the company’s 510(k) clearance filing, Pope said. But the company still expects to receive regulatory clearance in the first quarter of 2016. TransEnterix is planning for a second quarter SurgiBot launch. By then, the integration of the Italian robotics unit into TransEnterix is expected to be complete.
TransEnterix also plans to secure FDA clearance for the ALF-X in the United States. TransEnterix would pay SOFAR $11.3 million upon reaching that milestone, or on Dec. 31, 2016, whichever comes first. SOFAR is also due a $17 million milestone payment when ALF-X quarterly revenue reaches 25 million euros. In 2017, TransEnterix expects it will launch the ALF-X in the United States, as well as expand into additional international markets.
