BioPoly Knee System offers less invasive alternative to joint replacement surgery

By: Kay Rios Friday March 21, 2014 Tags: BioPoly LLC, CSU Ventures, CSURF, Dian Kammeyer, Fort Collins, Herb Schwartz, Susan James

By Kay Rios

InnovatioNews

FORT COLLINS -- A Fort Collins company's long years of development are now bearing fruit with a less painful way to regain joint movement.

BioPoly's RS Knee System resurfacing devices are already being sold in Europe and will hopefully soon provide another less invasive option in the U.S. to the more extremes of either biological treatments or partial/total joint replacement.

The BioPoly device uses a patented self-lubricating material that offers improved wear properties. It is uniquely designed to replace only the damaged portion of the cartilage. The BioPoly device appears similar to a thumb tack and can be easily inserted, replacing only the damaged portion of the cartilage with an implant that interacts positively with surrounding tissues.

Because the procedure is minimally invasive, the patient can begin walking immediately, allowing for quicker rehabilitation and return to normal activity.


The first implants in human knees were accomplished in January of 2012 in Europe, says Susan James, Colorado State University mechanical engineering department head and lead inventor of BioPoly's resurfacing technology.

"The patients are doing really well and -- so far -- the results are outstanding. The youngest patient was 20 years old, back to full active life within weeks of surgery and pain free. The follow-up has been good and sales are expanding across Europe."

The device will be available in the U.S. once FDA approval is received, James said.

BioPoly and its technology has been in the works for some time.

"It dates back to the mid-90s when I was applying for an assistant professor position," says James. "At that time, total joint replacement was the only option using plastic and metal. The main problem was the wear of the polyethylene plastic component. Little pieces of plastic would come off, cause an immune response in the body and that response would result in the destruction of bone."

As the bone deteriorated, the implant would become loose, she noted. "We began looking for a way to make the plastic wear longer."

BioPoly is a "bio-inspired" material, James says. "Cartilage is a well-lubricated material, and a significant portion of that is water. When plastic is used in joint replacement, we find it doesn't like water. So the original concept of BioPoly was to make the plastic component of the implant look more like cartilage to the body. Instead of having a waxy water-phobic surface, we wanted to create a water-loving surface."

The challenge, James explains, was that an implant couldn't be built out of the type of molecules that are water-loving.

"The secret to BioPoly is this molecule called hyaluronan," she says. "Your body is full of it and your joints are full of it. It's part of the lubricating process. It's slimy and mucous-like, so it's great for making things slippery but it doesn't have the structural integrity to build an implant.

"Knowing that, we started working on how we could take a molecule like hyaluronan and put it into the surface of these implants. That meant we would need to use a hybrid approach. The idea was to improve the plastic by putting this snotty molecule on the surface, making it better lubricated and liking water. And because hyaluronan is a natural molecule, it's less likely to cause an immune response like the original plastics. We spent many, many years in the lab with many students working on developing this technology."


After finding success, a patent on the chemistry and manufacturing process was applied for and received by CSU. In 2006, BioPoly was formed as a company as a subsidiary of Schwartz Biomedical Company by Herb Schwartz, president and CEO, and an agreement was formalized allowing use of the patented process.

"The patents we have licensed to BioPoly are the intellectual property of Colorado State University Research Foundation," says Dian Kammeyer, director of licensing and business development for CSU Ventures. "We are the agent of the University for technology transfer and that includes ownership of CSU's intellectual property. We work on commercialization of the intellectual property and, to accomplish this, the ownership is transferred to CSURF so we have the full right to enter into licensing contracts."

Kammeyer explains that "Schwartz Biomedical is an Indiana startup that had received some Indiana state funds for a 21^st Century startup grant. CSURF became involved because we helped Herb win the grant by leveraging the James et al. patent. The 21^st Century grant provided Sue James and her lab with research funding to further develop the technology via a subcontract to CSU.

"Herb now has the exclusive license to the patent portfolio. But we still own the intellectual property."

"Herb is very smart businessman and scientist," James says. "He made a commercial and market-driven decision about how to use BioPoly first. Instead of looking at the total replacement market, he went with the partial resurfacing knee implants. He did it for a couple of reasons. Essentially, the total replacement market is dominated by a small number of players who are relatively large companies and that would have been harder for him to enter. He looked at partial implants and found there was hardly anything on the market."

In addition to that, James notes, the patient experiencing knee pain is becoming younger. "You don't want to use a total knee replacement for a younger patient because total replacement has a limited life, so this is a good option."

Schwartz is working on FDA approval but says that will take time. He is also looking at the possibility of using BioPoly in other joints. "Full implants are definitely in the pipeline," he says. "Other joint resurfacing applications have been and are being developed. In fact, I'm planning a press release in the coming weeks to announce our latest approved product."

BioPoly LLC has the license for all medical applications of the technology.

James is glad to see BioPoly in use but says it's been a long haul.

"Persistence is the name of the game with this type of invention," she says. "We ran into hurdles and obstacles. I had the first idea in 1993--a dream in the middle of the night and the patents didn't get filed until 1999 or 2000. The first implantation didn't happen until 2012.

"We call it 'research' and not 'search' because it never works the first time."