UPDATED Sept. 19, 2016, with comment from Acelity.
Progenerative Medical said this week that it inked an exclusive licensing agreement with Acelity subsidiary Kinetic Concepts Inc. for a negative-pressure technology portfolio it aims to develop for spine and general orthopedic procedures.
The announcement is a long time coming for CEO James Poser, who worked at KCI for a year as vice president of global R&D back in 2007. Poser told MassDevice.com that a KCI colleague mentioned the interesting effects of negative pressure therapy on bone formation. He told his colleague to investigate and get back to him in 6 months.
“And he did,” Poser told us. “In the end, we had a profound understanding which we translated into a very significant intellectual property portfolio.”
After Poser left the company in 2008, the KCI team continued to develop preclinical data with the intention of taking its negative pressure technology to clinical trials.
“They met with the FDA, they crossed all of those hurdles – all of the pre-clinical work was done. All the engineering and development was done. It was a very significant effort at Kinetic Concepts, but the decision was made when the company went private, under new ownership, to discontinue that development,” Poser explained.
An Acelity representative told MassDevice.com that the decision not to pursue the technology was part of “the transformational journey to Acelity.” “In the creation of Acelity, the company’s [KCI] goals shifted away from those investments and more towards the investments we made in advanced wound therapeutics and regenerative medicine,” corporate communications VP Cheston Turbyfill told us.
A consortium of Canadian pension funds and private equity player Apax Partners paid $6.3 billion to take KCI private in 2011.
Poser told us that he and his colleagues saw the opportunity in the disused KCI tech and formed Progenerative Medical in February 2015 to take advantage of his connections at KCI.
Negotiations over a licensing deal closed in June, marking the 1st time Kinetic Concepts has ever licensed a piece of its technology and intellectual property. Progenerative, self-funded thus far, is looking to raise venture capital for clinical trials for a spinal indication, he said.
“We consider ourselves to be a startup company, but in reality, we are a company that is ready to move this technology forward into clinical evaluation,” Poser told us. “Now we are ready to put some fuel in the tank to really drive the process of bringing this technology forward for clinical evaluation with a very focused effort looking at specific spine indications as a primary objective.”
Negative-pressure therapy is a well-established procedure for healing chronic wounds. But after they noticed the effects it was having on bone, Progenerative Medical wanted to take advantage of what they estimate is at least a $650 million market in the U.S.
“Bone is not a static tissue,” Poser explained. “It’s not just some protein and some mineral. All of the biology is driven by cells, and those cells respond to their environment.” Poser, who has spent his career researching bones, explained that a type of bone cell which regulates communication, called osteocytes, respond to what’s known as fluid flow.
Recent research on fluid flow, the movement of interstitial fluid within bones, revealed its importance in bone regulation and formation, he said. “Negative-pressure therapy enhances fluid flow in bone and sets up a cascade of events which reaches what we call the threshold for stimulating bone formation,” Poser told MassDevice.com.
Progenerative’s 1st product for trial, Regenn Therapy, is designed for lumbar interbody spinal fusion, a decision Poser said was made based on “exquisite” pre-clinical data.
Poser, a 20-year veteran of the orthopedics industry, said he’s well-connected in ortho hotbed San Antonio’s investment circles. Orquest, a company he started in 1994, was sold to DePuy Spine in 2001 for $75 million.
But Poser said he’s a scientist before he‘s a businessman.
“There’s a time when you step out of the laboratory and you move behind a desk, and I guess I’ve been behind the desk for a while,” he told us. “But those who work with me understand that my greatest passion is to still be at the bench, breaking test tubes.”