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Courtesy Fortimedix

Fortimedix Surgical adds $12 million to launch laparoscopic solution

by Thomas Dworetzky , Contributing Reporter
More funding is in the works for single-port laparoscopic surgery device maker Fortimedix Surgical, which has secured $12 million in a Series A funding round led by Netherlands-based Chemelot Ventures.

The funds will be used to help launch the FMX314 — the first single-port surgery solution that works with the standard 15mm trocar for abdominal laparoscopic surgery — in the U.S. and Europe, according to a company statement.

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“We believe [the FMX314] can deliver on the promise of single-port laparoscopic surgery,” Chemelot Ventures Managing Director Casper Buens said.

The company has received additional funds from investment fund MKB Leningenfonds and Rijksdienst voor Ondernemend Nederland, a part of the Dutch Ministry of Economic Affairs.

The device holds the promise of fewer port-related complications, less pain and faster healing. It emulates “conventional, multi-port laparoscopy,” according to the company, which allows surgery to be done comfortably by physicians used to conventional approaches.

The device has received 510(k) FDA clearance in the U.S. and CE Mark approval in Europe.

“Our company is poised for significant growth, as we continue to achieve regulatory milestones to introduce innovative surgical instruments in key markets around the world,” Marc van de Graaf, VP Global Business Development of Fortimedix Surgical, recently stated. “Following 510(k) clearance from the United States Food and Drug Administration last August, this CE Mark allows us to expand the availability of our innovative technology to patients in Europe, who will benefit from the unique advantages of FMX314.”

The official launch for the FMX314 is slated to take place at the American College of Surgeons (ACS) Clinical Congress October 16 – 20, 2016, in Washington, D.C., with a European launch to follow in 2017.

Just this week UC San Diego Health Chief of Minimally Invasive Surgery Dr. Santiago Horgan removed a diseased gallbladder – a laparoscopic cholecystectomy – using the FMX314.

“What we are seeing is the rapid evolution of traditional laparoscopy toward less and smaller incisions — just one tiny incision, in fact,” said Horgan, who is also a professor of surgery and director of the Center for the Future of Surgery, UC San Diego School of Medicine, as noted in a UCSD report. “Normally, a gallbladder removal would be performed with four incisions across the abdomen. We achieved the surgery with one small cut hidden in the umbilicus. So not only are there fewer incisions, the one that remains is incredibly small.”

Horgan is renowned as a leader in the development of minimally invasive surgical techniques. He was the first U.S. surgeon to perform an appendectomy through the mouth in 2008.

His 30-minute gallbladder procedure was performed under general anesthesia, with the patient going home that day and without complications.

Fortimedix Surgical, which is headquartered in The Netherlands, has a U.S. subsidiary in San Diego.

About 600,000 people undergo surgical gallbladder removals each year in the U.S.

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