Lexington, KY - When he was president of the University of Kentucky, Lee Todd strongly encouraged faculty members to take their original ideas to the next step and turn them into new businesses and jobs to better the commonwealth.
One company to emerge from the minds of UK personnel was technology incubator Therix Medical. And now, Therix has managed to spin off a company of its own - Bluegrass Vascular Technologies (BVT), which develops and commercializes devices and methods that improve vascular access procedures.
"I had a patient who needed kidney dialysis, but all of their veins to the body were obstructed," recalled Dr. John Gurley, founder of the two companies and a cardiologist and director of the heart catherization lab at UK's Gill Heart Institute. "I had thought about that for years: What do we do when we run out of veins? I could never come up with an idea. This one patient forced my hand and into a solution."
"This type of vein problem is quite common in the population of patients with chronic kidney disease," said Gurley. Over the years, dialysis treatments can use up veins, and the patient is left with a crisis. This may also occur with patients who need pacemakers and defibrillators and some who get chemotherapy through infusion ports.
"Since I couldn't go into the body with a needle from the outside, I could turn the process around and start inside the body and aim the needle outward," Gurley said. "All we needed was some tools to guide the proper direction of the needle."
At a Therix meeting, Gurley explained to his colleagues what he had done and the whole Therix team felt the concept should be developed. That's when the Surfacer Inside-Out Access Catheter System was born.
At first, Gurley modestly didn't think his idea was worth much. It was typical of what he and his colleagues did every day.
"That is, when we run into a problem, we solve it. We think about how to get the patient better, not how to build a commercial product," he said.
The Surfacer has been used successfully in a clinical trial in Paraguay with the first six patients being treated successfully. Paraguay was chosen because its regulatory timelines are much shorter than in the United States. An additional 20 patients are expected to enroll in the trial before the product is taken to Europe for regulatory clearance and eventual sales.
Eventually, Bluegrass Vascular Technologies hopes the Food and Drug Administration, which is slower and more deliberate, will approve the procedure here, perhaps in 2013.
Jim Clifton, president of BVT, said many good medical technology ideas flow from UK. He and his team apply a rigid model of assessment and choose from that list a small subset of projects to pursue.
BVT came from that process. Normally, a larger medical device company such as Boston Scientific searches for ideas that could be sublicensed, developed and commercialized. "But if one of our ideas meets a higher set of criteria, we have a chance to spin that idea out into a company," said Clifton.
Clifton said Gurley's procedure appeared as though it could solve critical clinical needs in chronically sick people. It could extend and save lives. Gurley's solution became intellectual property.
"We went to an IP attorney in Minneapolis who had decades of cardiovascular catheter experience," said Clifton. "Once he determined that this was a novel approach, we had the green light to begin further assessment, development and investment in the company."
The Surfacer is BVT's headline product but with various refinements will have a broad application. The company anticipates a family of products being rolled out underneath the Surfacer name and within the BVT family.
The next step for Bluegrass Vascular Technologies is for Clifton to hire an executive team to flesh out the company from an organizational standpoint.
"Once that's accomplished," said Clifton, "we'll bring [the Surfacer] back to the U.S. for regulatory clearance."
With 650 doctors at UK, plus a couple of thousand support staff who treat sick people daily, Clifton believes that "from an intellectual property and idea standpoint, we're sitting on top of a large untapped resource."
Gurley, who came to UK in 1984, wants Therix doctors to solve tomorrow's problems.
"We don't necessarily want them to follow the rules and do what other doctors are doing already. We want them to think forward. Anything we do, we can do better. Things we think we can't do - well, maybe we can. That mindset is developed to the point where we see commercial products in the face of clinical problems," Gurley said.
Gurley is pleased with the results of the first clinical trials on humans. He honestly didn't know what to expect, but finding ways of saving lives was paramount.
"That's the best part, which is why I and most of my colleagues are here. We want to help our fellow man. We took a problem that nobody could solve and solved it," he said. "Now we can spread the solution around and give it to other physicians. That's cool."