Toe Implant Kicks Off BioPoly’s U.S. Implants

The implant replaces the damaged cartilage

After a series of successful products in Europe, a Fort Wayne-based orthopedic startup is putting its best foot forward in the U.S. market with the BioPoly Great Toe Implant. The device, and all the implants that came before it in BioPoly’s portfolio, uses the startup’s key technology: a “self-lubricating” polymer that behaves more like natural cartilage. BioPoly President Herb Schwartz says the device eliminates pain for the patient and establishes an important foothold in the U.S. market for the startup—a major step toward commercializing more products in its U.S. pipeline.

BioPoly’s knee implants have been used in Europe for nearly a decade, but the Great Toe Implant will be the startup’s first device for American patients. Like all of BioPoly’s implants, the “big toe” device uses the startup’s unique orthopedic material, which it licensed from a researcher at Colorado State University.

The material combines polyethylene, which Schwartz describes as a plastic, and hyaluronic acid, a gooey substance that occurs naturally in the body to attract and retain water to keep tissues well-lubricated; it can be found in large amounts in joints’ connective tissues. Combining the two creates a “water-loving” polymer that attracts the body’s lubricating joint fluid to the implant’s surface.

“There’s something called synovial fluid, which is lubricating fluid for all of your joints. BioPoly actually attracts that lubricating fluid to the surface and [holds on to] that lubrication while your joint is moving,” says Schwartz. “We replace damaged cartilage or [joint] surface with our BioPoly material, and the opposite side of the joint is still intact and still has cartilage and natural tissue; BioPoly can rub against the natural tissue without causing damage, because of that lubricating property of BioPoly.”  

The “self-lubricating” polymer is more similar to human cartilage, unlike conventional metal implants, which BioPoly says are 16,000 times stiffer than cartilage. A common concern, Schwartz adds, is that a traditional implant wears out the other side of the joint as the metal rubs against healthy tissue.

Joint pain in the big toe—or the “Great Toe” in the orthopedic world—is a very common ailment, says Schwartz, and usually caused by arthritis. He says the current standard of care is a fusion, in which the joint is locked into place, reducing pain because the joint can no longer move.

“But there’s also lost mobility, because you don’t move that joint anymore. With our material, we can just replace the damaged portion of the joint. And other implants out there are made of heavy metal… but then you have metal rubbing against cartilage,” says Schwartz. “In our opinion, fusion should be the last resort, and now it’s kind of the first thing they go after. Based on our orthopedic surgeon and podiatrist input, we felt this was the market to go after. And it’s actually a pretty sizable market.”

Earning regulatory approval for the Great Toe Implant “opens the door for virtually any joint” in the U.S., says Schwartz. BioPoly will likely add more foot and ankle products, and Schwartz says “a knee and shoulder product are coming down the pipeline now.”

“That’s the hardest part about where we are right now; we have so many choices, we want to make sure we pick the right one,” says Schwartz, “because we have limited resources to bring [these products] to market.”

Because of the material’s anti-thrombogenic properties, meaning it can prevent the formation of a blood clot, BioPoly is even exploring cardiovascular applications. Schwartz says a stint or heart leaflet valve could be made out of the material or coated in it “so the patient doesn’t have to be on Plavix the rest of their life.”

Founded in 2006, BioPoly manufactures all of its implants at its Fort Wayne headquarters and will likely partner with other manufacturers in the nearby Orthopedic Capital of the World to support the higher volumes expected in the startup’s U.S. portfolio.

“I want to give credit to the entire BioPoly team; we’re a company of seven [employees], and they’re very committed, very smart and innovative and have done a great job to design, develop and now manufacture these implants.”

Schwartz says it “has been a long road to get in the U.S.,” and the team is excited to finally dip its toe into the new market.

“We’ve been implanting in knees since 2012, and we see those patients and how it changes their lives; their pain goes away, they get their mobility back and can improve their overall health,” says Schwartz. “We see a huge benefit finally available to the U.S. population, starting with the toe, and then expanding to the other joints.”