Pathfinder Therapeutics' five-year journey to bring a device and software to market to vastly improve liver surgery is nearly over. With federal Food and Drug Administration approval in hand, the Nashville-based company is set to release its products in December.

 

"Surgeons are getting very excited about the software and the images that we're providing them, and they're eager to utilize the product in the OR," said Skip Goode, who joined the company in March as president and chief executive officer.

 

In December 2007, Pathfinder received FDA clearance for its SurgiSight Linasys (short for liver navigation system), an integrated system of hardware, software and instruments that Goode described as a "GPS for surgery." SurgiSight offers surgeons a real-time look through the liver to more precisely guide their instruments for liver procedures such as hepatic resection, open ablation, open biopsy, living-donor transplant and cyst removal. "As the surgeon moves the surgical instrument in the surgical space, he can look up on the computer screen and see exactly where that instrument is. He can use that system to guide him to his destination," Goode explained.

 

Pathfinder's second product, PlaniSight Linasys, was FDA approved in September 2008. It's the companion software that allows the surgeon to pre-operatively plan for the liver surgery by registering and mapping the patient's anatomy. Melding the two products results in the surgeon's unique three-dimensional view.

 

Launched in 2004, Pathfinder is a spinoff of research conducted by Vanderbilt University biomedical engineers, electrical engineers and surgeons. Several of them founded the company, including Jim Stefansic, who worked on the project as a Vanderbilt graduate student and left his university research position to run Pathfinder. "To throw the technology, as we say, 'over the wall' to a company and actually get something to market is easier said than done," said Stefansic, who is Pathfinder's chief operating officer. He acknowledged that raising capital has been a challenge, but that changed in October 2008 when the company closed on a $5.2 million Series A financing round led by Hatteras Venture Partners, based in Triangle Park, N.C. The company also secured a $3.5 million grant from the federal Small Business Innovation Research program. Expect a second round of financing perhaps next spring, Goode added, and the search is still on for additional investors to join those already on board.

 

Clinical studies are ongoing, with about 70 procedures under the company's belt as of October. "We have verified that we can register the patient's anatomy and keep that anatomy in registration. Now, the next step is to attach a device to the surgeon's instrument and do a complete resection," Goode said. Some of the early clinical work was done at Vanderbilt, but most of the later studies have been conducted at Memorial Sloan-Kettering Cancer Center in New York, the University of Pittsburgh Medical Center and the University of Florida Shands Cancer Center. William Chapman, MD, formerly with Vanderbilt and a Pathfinder founder, is now head of transplantation at Washington University in St. Louis; thus, a few studies have been conducted there, as well.

 

It was Chapman who got the Pathfinder ball rolling at Vanderbilt when he expressed interest in image-guided tools for liver surgery that would mimic those used by his colleagues in neurosurgery.

 

"One of the main reasons Dr. Chapman was so interested in this was liver cancer," Goode explained. "If those patients can have the liver cancer resected, about 50 percent have a life expectancy of five years or greater. If the tumor is not resected and is treated with chemotherapy or radiation, only 5 percent live five years or longer. The challenge then and now is that only about 18 percent of the patients diagnosed with liver cancer are candidates for resection based on the location of the tumor."

 

That's because the liver is such a vascular structure — inoperability because of blood-loss concerns is a real possibility. Currently, surgeons rely on preoperative CT scans, which clearly show the liver and the tumor but not the vascular structures. "The objective of the Pathfinder products is to take some of those 82 percent who aren't surgical candidates and move them to where they are surgical candidates," Goode said.

 

Next on the list for Pathfinder are the pancreas and the kidneys. "Many liver surgeons also do pancreas, so when the liver surgeons see these incredible images that we provide for the liver, they say, 'Wait a minute! I need these for the pancreas also,'" Goode said, adding that kidney ablation procedures are expected to benefit tremendously from Pathfinder's image-guided process.

 

Located on Armory Drive near 100 Oaks Mall, Pathfinder has 15 employees and expects to double that number in the next year. Most are research scientists and engineers, who will be joined by technicians to build the products in-house. The company already has earned its ISO 13408 certifications, meaning it has met all regulatory and quality requirements to manufacture a medical device. Said Stefansic, "We're doing everything here in Nashville, which is really exciting. We're one of the few medical device companies that does it all here." While Memphis boasts a thriving medical device industry, Nashville is working to build that sector, and Pathfinder is an early member of the club.

 

A native of Memphis, Goode moved to Nashville from Colorado to take the helm of Pathfinder, bringing with him sales and product-launch experience at several medical device companies. "This was a good opportunity and a way to get back to the South," he said.