TransEnterix readying FDA filing of SurgiBot in mid-year
TransEnterix (NYSE MKT:TRXC) plans to file for FDA approval in mid-year of its SurgiBot robotic platform to enhance minimally invasive laparoscopic surgery through a single surgical incision.
“We anticipate a six-to-nine month review cycle for our 510(k) submission and hope to launch in the first half of 2016,” CEO, Todd Pope, says in an interview with BioTuesdays.com.
If approved, SurgiBot would be the second major player in robotic surgery after industry leader, Intuitive Surgical’s da Vinci system. “We do not intend to directly compete with Intuitive but rather expand the market,” he adds. “There is a vast opportunity for our system between traditional laparoscopy and existing multimillion dollar robotic systems.”
Mr. Pope contends that SurgiBot addresses unmet needs in today’s robotic surgery by being cost effective and having broad procedure applicability.
“The big differentiator of our platform is that it allows doctors to be beside their patient during surgery rather than sitting at a console. This allows a surgeon to have his or her hands on the instruments so they have tactile feedback similar to a traditional laparoscopic procedure,” he adds.
Founded in 2006, TransEnterix received FDA and European approval for its Spider Surgical System and a suite of flexible laparoscopic instruments. More than 3,500 procedures have been performed with Spider. In 2012, the company began developing SurgiBot, incorporating many features suggested by surgeons.
“We robotized our manual platform for improved dissection and retraction strength, enhanced precision and control, improved surgeon ergonomics and advanced visualization, with articulated 3D cameras,” Mr. Pope recalls.
“The system also has a small, mobile footprint in the operating room and hospitals do not have to dedicate an entire OR for robotic surgery,” he adds. The flexible nature of the system allows for multiple instruments to be introduced and deployed through a single incision.
Mr. Pope says TransEnterix figures SurgiBot’s market opportunity is about two million laparoscopic procedures a year, targeting gall bladder, colorectal, gynecology/urology and bariatric surgery.
Stifel analyst, Rick Wise, in a recent research report, said that his due diligence at the 2015 Society for Robotic Surgery meeting suggests broad potential SurgiBot applications in a number of large procedure opportunities.
“In time, we envision the SurgiBot platform could evolve to include iterations that address a seemingly growing clinician demand for natural orifice access,” he wrote. “Most obvious, to us, would be SurgiBot trans-anal access for rectal/colon-centric procedures, for instance.”
Mr. Wise rates TransEnterix at “buy,” with a price target of $7. The stock closed at $3.54 on Friday.
Earlier this month, the company successfully completed its Good Laboratory Practices (GLP) studies using the SurgiBot system, one of the key remaining steps prior to its 510(k) submission to the FDA in mid-year.
Mr. Pope says the GLP studies included multiple procedures performed by surgeons from varying specialties to demonstrate the system’s ability to handle critical tasks commonly performed in laparoscopy.
“I prefer to be at the patient’s side during surgery, and appreciate maintaining the approach and movement of gold standard laparoscopic surgery while adding the features of robotic assistance,” Dr. Michel Gagner, president of the 2014 World Congress of the International Federation for the Surgery of Obesity & Metabolic Disorders, and one of the investigators for the GLP study, said in a statement.
According to Mr. Pope, TransEnterix is receiving interest about SurgiBot from hospitals with and without robotic capability. He points out that there are more than 3,000 mid-to small-sized hospitals in the U.S. with fewer than 300 beds, and more than 80% of them do not offer robotic surgery.
“We figure this could represent more than 800,000 annual procedures for SurgiBot,” he adds.
In addition, he contends that healthcare economics are driving rapid procedure growth at some 5,000 surgery centers in the U.S. “With the cost benefits of SurgiBot, this is a big opportunity for us because fewer than 1% of these surgery centers have robots.”
He says a SurgiBot system is priced at around $500,000, with disposable instruments at $1,000 to $1,500 per procedure. That compares with existing robotic systems that have a capital cost in the range of $1.5-million to $2-million each.
“We have a good core competency in understanding how to build manual instruments for laparoscopy, and we think that will serve us well going into SurgiBot,” Mr. Pope says.