Garwood Medical Devices President and CEO Wayne Bacon demonstrates how a needle used in experimental BioPrax technology makes contact with a knee implant to start a low-voltage electrical circuit that has the potential to revolutionize the way implant-related infections are treated.
Dr. Scott R. Nodzo, right, a knee and hip joint replacement specialist, goes over an image with physician assistant Barrett Gast. Nodzo will lead clinical trials in collaboration with Garwood Medical Devices and University at Buffalo researchers of the BioPrax infection-killing device.
Wayne Bacon, a Buffalo industrialist turned entrepreneur, launched a medical device venture almost eight years ago, hoping to create an adhesive bandage with infection-fighting ingredients.
University at Buffalo medical school researchers had a different idea: Why not focus on an experimental concept to use electrical stimulation to help joint-replacement patients fight off infections?
Now Garwood Medical, Bacon's refocused company, has a chance to become the next hot Buffalo startup. The company has raised more than $14 million, hired a small staff and helped patent a new technology, called BioPrax, that is so promising the FDA granted it breakthrough device status two years ago to speed up the federal approval process.
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As Buffalo Niagara reinvents itself, Garwood Medical offers the kind of economic kindling regional development experts crave. The effort started with research at the University at Buffalo and Syracuse University. University and company scientists have collaborated since. And a novel idea continues to attract money and expertise in the push toward commercialization.
From Silicon Valley to Boston to Austin, that is a proven startup path.
The company's potential is big. Treating an infected hip or knee replacement can require two surgeries and implant removal, as well as long hospital stays and rehabilitation. An estimated 40,000 such procedures take place every year in the United States. Almost half of patients never get another implant and the five-year mortality rate is 34%. The medical costs, studies suggest, approach $2 billion.
Bacon sees an even bigger market. He and other Garwood founders hope it will become standard treatment for other implants – shoulders, spine and maybe even dentistry.
“Our long-term goal is for this technology to prevent infections in the first place,” said Brian Peterson, a Garwood co-founder.
But Garwood’s obstacles are big, too. The company's next major hurdle is getting FDA permission to start a small-scale human trial. If that shows promise, a broader study must follow. Under the best of circumstances, the first BioPrax sale is likely at least three years away.
This is a test for Buffalo Niagara. The region doesn’t have a robust medical device industry to supply the talent, capital and advice that Garwood needs to grow. And for startups, there is always the chance that an established company will buy them and move them elsewhere. The region must prove such a company can take flight here.
“For the company to take off – and be successful – would be a game changer for how joint replacement patients are managed – and the market for that would be absolutely huge,” said Dr. Timothy Murphy, professor and senior associate dean in the UB Jacobs School of Medicine and Biomedical Sciences. “The technology of this is most exciting to me.”
Garwood Medical’s treatment is aimed at a stubborn problem: About 2% of the more than 1 million knee and hip replacement surgeries each year become infected. Antibiotics often can't treat the infections in the area around the joint and the surrounding bone and tissue.
Surgeons must then remove the artificial joint, scrub away the infection, disinfect the area and implant a temporary cement spacer. Patients may spend months on IV antibiotics before a surgeon can consider implanting a new prosthetic joint.
The costs can run as high as $270,000, 10 times more than joint replacement surgery. “This bankrupts people,” Bacon said.
Garwood’s invention essentially turns the implant itself into an infection-killer. A thin needle is inserted into the joint to make an electrical connection with the implant. That causes a reaction that generates infection-fighting activity around the implant.
The magic is finding the most effective voltages to use on different implants, depending on the type of metal they contain. Garwood’s staff has spent the last four years improving the system.
“This is actually more natural than antibiotics,” said Peterson, an electrical engineer.
Early work of University at Buffalo associate biochemistry professor Mark Ehrensberger, right, created the foundational principles of the BioPrax medical device. Microbiology professor Anthony Campagnari and others helped improve the technology and prepare the device for clinical trials.
The start: An inquisitive graduate student
The idea for Garwood’s novel treatment started 15 years ago with Mark Ehrensberger, an Erie, Pa., native and bioengineer, who began exploring the idea while a doctoral student at Syracuse University.
After graduating in 2008, Ehrensberger came to UB to become director of the Orthopaedic Research Laboratory. Two months after he arrived, he contacted Anthony Campagnari, the medical school's senior associate dean responsible for encouraging collaboration among medical researchers.
“I didn't really have a good foundation in the microbiology and he's a professor of microbiology,” Ehrensberger said.
The duo forged a research team that has secured more than $3.2 million in grants, starting in 2010 with a $620,000 Department of Defense idea grant to evaluate the fundamental technology that would become the BioPrax therapy.
Animal studies from 2014 through 2016 showed that the process could reduce infections on the implants, as well as on surrounding bone and tissue. Adding antibiotics to the treatment heightened the effect.
UB and Syracuse University jointly own the U.S. patent for the BioPrax technology, awarded in 2017. The schools exclusively licensed it to Garwood Medical Devices for commercialization.
A restless businessman and a bioengineer
Wayne Bacon wasn’t an expert in knee replacements or medical devices. But he was a veteran businessperson – he owned Mills Welding & Specialty Gases in Buffalo for 24 years before selling it in 2007 to Praxair. After the sale, he dabbled in real estate and thought he would coast into semi-retirement, but he couldn’t shake his lifelong interest in building companies.
So in 2014 – at age 66 – Bacon started exploring an infection-fighting bandage. He recruited Peterson, who was working in Boston for Greatbach Medical, a device company based in Alden. Later that year, Bacon and Peterson co-founded Garwood Medical Devices.
In early 2016, while Bacon, Peterson and UB researchers were using UB supercomputers to model how energy flowed through the body with the infection-fighting bandage, Jeffrey Dunbar, director of the university Technology Transfer office, suggested the company owners might be interested in BioPrax.
Bacon was sold. Peterson worked from outside Boston as the new company developed, trying to help find the best combinations of metals and electrical current.
"Electrochemistry is very dependent on the metal you're attaching to, so we have done a lot of work," Peterson said. “Our electronics have simplified a very complex science, so you just hit a button and the device handles the control parameters.”
Peterson, a New England native, helped apply for the BioPrax-related patent, then started full time after patent approval the next year. He moved to East Aurora in 2019, after the Food and Drug Administration granted breakthrough device status to BioPrax.
“I am actually a Buffalo Bills fan,” he said. “I had to bring in pictures to prove it.”
Bacon funded the company for its first two years, until Garwood raised $3.6 million from investors in 2016. It raised $3.8 million more in 2019 and $7 million last year. Most investors came from the region, though some in the latest round hail from Mexico and Sweden.
The next big test: human trials
Garwood’s next big test is the first human clinical trial, expected to start next year in Buffalo and up to five other sites. It will involve as many as 15 patients with implant-related infections and will take six months to a year to get trial results. If they prove promising, Garwood Medical will start preparing for a bigger trial involving other specialists and as many as 200 patients from across the country.
Clinical research studies are challenging. Many never reach completion, often because of a lack of research participants. UB researchers doubt that will be the case with BioPrax because of pent-up demand.
The company continues to do some of its work in UB labs on the Buffalo Niagara Medical Campus, but in June it opened a “red shed” research and manufacturing building at the Northland Corridor Redevelopment Project on the East Side. It now has a staff of 14, including the first machinist trained next door at the Northland Center. They have assembled a pilot production line and employed a half-dozen UB researchers who otherwise would have moved from the region.
At the insistence of the co-founders, the company tries to source more than half of its billable material and assemblies from Western New York. The aim is to increase the initiative's spin-off impact on the Buffalo Niagara region by using local sources for things ranging from injection molders, electronics supplies, packaging, powder coating and metal stamping to printing and legal support.
Bacon, Peterson and their staff are big on Buffalo.
“A successful launch of production in the region will mean FDA registration here,” Bacon said, “helping to ensure that we keep the production jobs in Buffalo, even if someone else invests in or purchases the company long-term.”
Will it work? Every startup is bullish, but Dr. Scott Nodzo, an orthopedic surgeon who will lead the human clinical trials, exudes confidence.
“We're still doing most of the same things we did 40 years ago – and our outcomes haven't dramatically improved,” Nodzo said.
“In terms of joint replacements, this is huge.”
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I have covered a variety beats and editor positions in South Florida, Syracuse and, since 2004, my home Buffalo Niagara region. Since 2013, I've been editor of WNY Refresh, which focuses on health, fitness, nutrition and family life.
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Garwood Medical Devices President and CEO Wayne Bacon demonstrates how a needle used in experimental BioPrax technology makes contact with a knee implant to start a low-voltage electrical circuit that has the potential to revolutionize the way implant-related infections are treated.
Dr. Scott R. Nodzo, right, a knee and hip joint replacement specialist, goes over an image with physician assistant Barrett Gast. Nodzo will lead clinical trials in collaboration with Garwood Medical Devices and University at Buffalo researchers of the BioPrax infection-killing device.
Early work of University at Buffalo associate biochemistry professor Mark Ehrensberger, right, created the foundational principles of the BioPrax medical device. Microbiology professor Anthony Campagnari and others helped improve the technology and prepare the device for clinical trials.
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