A single-port laparoscopic device designed to knock down a key barrier in the space has earned a financial boost just days ahead of the product's official U.S. launch.

Chemelot Ventures led Fortimedix Surgical B.V.'s €11 million series A round to support the company's FMX314, which recently won both FDA clearance and a CE mark, and is compatible with a standard-sized trocar that laparoscopic surgeons are most familiar with.

Fortimedix, of Nuth, Netherlands, plans to launch the device in the U.S. at the American College of Surgeons Clinical Congress next week in Washington, with a European launch to follow in 2017. The company said the FMX314 is the first single-port device compatible with a standard 15 mm trocar for abdominal laparoscopic surgery. MKB Leningenfonds, and Rijksdienst voor Ondernemend Nederland (part of the Dutch Ministry of Economic Affairs) also pitched in cash for the series A round.

"The biggest barrier to minimally invasive surgery has been the size of the available devices," Santiago Horgan, chief of minimally invasive surgery at the University of California San Diego Health, told Medical Device Daily.

Since the introduction of natural orifice translumenal endoscopic surgery (NOTES), a development Horgan has played a key role in, laparoscopic surgeons have been trying to cut down on the number of ports they use to only one. This advancement in the space, called single-port surgery, fills the gap between conventional five-port laparoscopic surgery and NOTES. Single-port still enters the abdomen from the outside, while NOTES enters the abdomen from the inside (lumen).

Existing single-port systems require a trocar that is more than 25 mm in diameter, which is larger than the standard trocar used to remove a gallbladder, Horgan said. Most laparoscopic surgeons simply are not comfortable using a system that size for the cases they do, he added, "but the momentum is there."

Horgan recently performed the first two U.S. commercial procedures with the new system to remove the patients' gallbladders. It was not the surgeon's first time using the device, as he has been involved with the company through the development and trial phase as a consultant, but it was his first two U.S. cases with the technology. More importantly, he said, it was the first time his U.S. surgical team (nurses and other operating room assistant), had been involved with a procedure with the FMX314.

"I was impressed with how quickly they adapted to the new device," Horgan said. "The first case took 40 minutes, the second case took 30 minutes, so there was a very short learning curve for the surgical team. Nobody felt overwhelmed by the size of the device, nobody felt threatened – which are things that may happen in the operating room. Everybody felt comfortable with the technology very quickly."

Being aware of how a new technology impacts the entire surgical team, not just the surgeon, is important, he said, because the field has shifted to emphasize a team approach in the operating room, a trend that he said has emerged just over the past 10 years of his 25-year surgical career. From a business standpoint, keeping the learning curve short for the entire team also tends to make a difference in terms of adoption rate once the product is on the market, he said.

Horgan said the new device could help reduce the rate of port-site complications, lessen the amount of pain patients experience after surgery, and lead to faster recovery and "exceptional cosmesis in comparison to conventional multi-port laparoscopic surgery."

As such, Horgan said he expects the Fortimedix technology to have an impact on the space, as the lower-profile solution is likely to be an attractive benefit to surgeons, especially as the company continues to develop the platform and release newer generations. Horgan said the Center for the Future of Surgery at UC San Diego Health averages 800,000 laparoscopic cases a year in which the FMX314 could potentially be used.

Chemlot Ventures' Casper Bruens, a managing director at the Netherlands-based firm, said the device has the potential to "deliver on the promise of single-port laparoscopic surgery." Chemlot has backed Fortimedix since 2004, the company from which Fortimedix Surgical emerged in 2012.