A Fort Wayne-based orthopedic startup is nearing the beginning of an FDA-approved clinical trial for its knee implant that could help people avoid total knee replacement.
BioPoly has its first patient on the schedule for the BioPoly Partial Resurfacing Knee Implant, which is designed for middle aged patients who are too young for total knee replacement.
CEO Herb Schwartz told Inside INdiana Business the implant surface uses an orthopedic biomaterial created that self lubricates and mimics cartilage.
“It’s kind of like a pothole forming in a road, and so if you can catch that pothole and fill it before you have to resurface the entire road, that’s what we do with BioPoly knee implants,” Schwartz said. “For this type of implant in particular, the market is in the billions of dollars for the for the U.S. alone. So it’s a very big market that’s barely being tapped right now.”
Schwartz said the implant addresses what are known as focal defects in the knee, and the BioPoly implant’s material is helps take the pain away and give patients their mobility back.
BioPoly is the only company that has the material available to it, Schwartz said. The proprietary material is polyethylene that is combined with a molecule called hyaluronic acid that changes the nature of the material.
“Hyaluronic acid…its job is to attract water to itself and in a joint environment, there’s fluid called synovial fluid that’s used for lubrication, and that’s what cartilage uses for lubrication,” Schwartz said. “That’s what BioPoly uses as well. That’s why our material is used in these applications, because it mimics the function of cartilage and can be replaced.”
BioPoly has 23 patents issued for the material and the implants that use it. The material is manufactured in Fort Wayne.
Schwartz said the implant could be a game changer for middle aged patients, for whom the number of existing treatments are limited.
“The treatment options aren’t really available for them from a biological standpoint, and then they’re too young for a total joint,” he said. “So they’re in this gap here, and they’re kind of left to be treated pharmaceutically or with injections and just trying to push the patient along to until they get old enough to get a total joint. So what BioPoly does is it fills that gap for that middle aged population.”
BioPoly has used the Partial Resurfacing Knee Implant in Europe since 2012, serving about 1,250 patients to date. The company has its first surgery in the U.S. scheduled for August, with the second coming shortly after that.
“There’s 156 patients that we need to enroll and do the surgery on, and we’re going to do that throughout the United States,” Schwartz said. “We’re gonna have about 10 sites that will be part of this investigation group. We’re focusing on completing this study, because once the patients are all enrolled, we have to wait two years to get the results in.”
The clinical study is estimated for completion at the end of 2028.
Schwartz said he’s proud of what his team has accomplished so far, and he’s excited to finally bring the knee implant to the U.S.
“Even though we’re small, we can do so much; we’re doing things that big companies can’t do,” he said. “It’s the team environment. It’s everyone carrying their weight and then some. We persevere, and we were very diligent in what we do.”