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Orthopedic-device makers are blurring the line between flesh and bone and metal and plastic.
With a growing array of orthobiologic devices, scientists are using animal tissue and the body’s processes to fix damaged bones and joints.
The technology is playing an important and growing role for the orthopedic companies concentrated around Warsaw. And regional entrepreneurs are working hard to get into the game.
“Orthobiologic” describes a broad field of technology, so it’s probably easiest to explain it by the devices’ function: They’re intended to help repair or regenerate – instead of replace – damaged bone and tissue, said Cheryl Blanchard, senior vice president and chief scientific officer of Zimmer Inc., a Warsaw orthopedic-device company.
About 2.2 million procedures using “augmenting materials,” or orthobiologics were done in 2007 in the United States, according to PearlDiver Technologies Inc., a Fort Wayne firm that analyzes the orthopedic industry. By 2014, PearlDiver expects that number to grow by 30 percent, to 2.95 million.
The technologies include devices developed by Zimmer to repair damaged cartilage before arthritis sets in.
After cartilage is damaged, it can degenerate, causing damage to the tissue and to the bone to which it’s attached, resulting in osteoarthritis.
Zimmer’s DeNovo NT and ET technologies are intended to fix damaged cartilage before things get that far. They work by inserting a mix of cut-up cartilage taken from cadavers and adhesive.
Once in the knee, the biologic device grows into the cartilage and the cartilage grows into the biologic device, which can be implanted in one surgery.
Warsaw-based DePuy Orthopaedics Inc. makes its Restore Orthobiologic Implant to repair soft tissue in the rotator cuff in the shoulder.
Made from the small intestine if a pig, the disc-shaped implant serves as a scaffold: It reinforces the muscles and tendons of the rotator cuff. As the tissue heals, the implant dissolves and is assimilated into the rotator cuff.
Orthobiologic treatments in soft tissue such as cartilage and muscle tend to be made in early in the continuum of care.
“On the bone side, it’s very different,” Blanchard said.
Biomet Inc., also based in Warsaw, makes orthobiologic products to help surgeons repair bones with complex breaks and other defects.
“We have devices that allow physicians to concentrate blood factors,” spokesman Bill Kolter said, describing the company’s GPS line of products.
The blood factors, used in conjunction with a demineralized bone matrix also made by Biomet, can help defects heal without resorting to a bone graft.
“It allows the doctor to use the body’s own resources,” Kolter said.
Research into such orthobiologic technologies has been going on for decades, but in recent years, the number of technologies moving from conception to clinical trial to market has begun to explode, said Herbert Schwartz, president of Schwartz Biomedical LLC in Fort Wayne.
Schwartz was a researcher for DePuy until 2004, when he started his own company. Now, with four colleagues, he works at the Northeast Indiana Innovation Center on Stellhorn Road.
This summer, Schwartz’s company sold its BioDuct technology to Stryker Corp. in Kalamazoo, Mich.
Where Warsaw’s big orthopedic companies make orthobiologics for bone and soft tissue, “we kind of play in the middle,” Schwartz said.
BioDuct helps surgeons to repair the meniscus, the cartilage that acts and a shock absorber in the knee. It routes blood to the damaged area – which normally doesn’t have a blood supply – to facilitate healing and then dissolves.
Schwartz and his team are developing BioPoly, a technology that will allow partial joint replacement using synthetic materials and a lubricating molecule found in the body.
With advancements in research using adult stem cells and other technologies, the possibilities of orthobiologics might seem endless. But don’t expect metal and plastic devices to become obsolete in the foreseeable future.
“It hasn’t been apparent that biologics are going to replace the orthopedic products,” said Matt Hall, a project director for BioCrossroads, an Indianapolis group that seeks to foster life-sciences businesses in Indiana. Hall helped complete a study this year of the orthopedic industry concentrated around Warsaw.
Kolter, of Biomet, characterized orthobiologics as “a small, but growing, part of our business.”
Kolter said Biomet doesn’t publicly disclose how much of its revenue is from orthobiologic technologies.
“We’re going to take incremental steps,” Schwartz said. “There are going to be some game-changers, but most of the steps are going to be incremental.”
And there are other considerations, such as the regulatory hoops a technology must clear before it gets to market.
“You have to be very practical as a businessperson and a scientist,” Blanchard said.
