Startup's device may change surgery

A Durham company has raised $21 million in venture capital to chase every surgeon's dream: to cure without cutting.

TransEnterix is a brain child of Synecor, a business incubator that spun out of Duke University seven years ago to turn medical device ideas into money makers.

The cash -- not a record amount but a lot for a tiny, barely operational Triangle company -- will allow TransEnterix to hire six engineers, build models of a medical device and, if all goes well, begin testing the device in about two years on patients undergoing abdominal surgery.

The Triangle is known as a hub for drug research, but an increasing number of medical-device companies are starting in the area. Most are small, and their inventions years from being ready.

Investors are willing to make bets because of the potential payoff of a major breakthrough.

TransEnterix's device could dramatically improve how some surgeries are performed: repairing a hernia or removing a gall bladder, ovary or appendix, for instance.

Despite advances, those operations require four or five small cuts to insert surgical tools into the abdominal cavity. Surgeons need tools to push, grasp and cut.

"What was considered minimally invasive 20 years ago is not minimally invasive today," said Dr. Richard Stack, a Duke University professor emeritus and co-founder of Synecor.

Surgeons stopped slicing patients' bellies open as laparoscopy gained popularity in operating rooms more than 15 years ago. In laparoscopic surgery, tools are mounted on rigid extensions and inserted into the abdominal cavity through cuts measuring less than an inch. Several openings across the stomach are necessary for surgeons to handle the tools.

TransEnterix's device inserts one package of tools mounted on flexible extensions. Once inside the abdominal cavity, the tools spread out, much like the fabric on an open umbrella.

Reducing the number of incisions would lower the risk of infection and lead to less pain, fewer scars and shorter hospital stays.

But a new device must be at least as safe and easy to handle as the technology already in use.

"It sounds really cool," said Dr. Tim Farrell, an associate professor of surgery at the University of North Carolina at Chapel Hill.

But TransEnterix's device has not been proved safe in humans, nor is it the only one of its kind in development, said Farrell, who regularly performs laparoscopic surgery. "It's one of these technologies where the detail is in the [clinical] data," he said.

Into the spotlight

Founded in 2006, TransEnterix has operated in obscurity, but Synecor plans to officially announce the company's formation and funding this morning.

Synecor came up with the idea for the medical device, spun out TransEnterix and orchestrated the $21 million in financing. Investors include Synergy Life Science Partners, a new venture fund Synecor participated in; Parish Capital Advisers in Chapel Hill; and SV Life Sciences, a Boston venture capital firm.

Synecor engineers built two prototypes of the device, and more than 60 patents for the device are issued or pending. But few people have seen or touched the device.

TransEnterix has a video showing the device being used to take out a pig's gall bladder. More tests in animals are necessary before tests in humans can start in about two years as planned.

By 2012, clinical tests could begin with a modified version of the device that would allow the surgeon to slip the tool package into the mouth, down the esophagus and through a cut in the stomach wall. The modification adds small balloons to prevent stomach acid from leaking during the surgery.

"This is a major transition of how surgery is done," Stack said.

Patients undergoing gallbladder removal, in particular, would benefit.

About 25 million suffer from gallstones in the U.S., according to the American Gastroenterological Association. Treatment frequently involves gallbladder removal. About 90 percent of those surgeries are done by laparoscopy.