Electrical stimulation could fix joint-replacement infections

You probably know someone with a knee or hip replacement. If not, chances are you will, as demand for these surgeries is expected to continue growing.

While widely successful, not all joint replacements go as planned. Infections are a serious problem, often requiring costly and painful follow-up surgery.

This could become much less common.

Researchers are developing a medical device that delivers low-voltage to a joint replacement or any metal inserted into the body. The electric signal creates an antibacterial environment that stops infections before they become problematic.

“Our goal is to eliminate the need for follow-up surgeries. We think we can wipe out infection-causing bacteria before trouble starts,” says Wayne Bacon, president and chief executive officer of Garwood Medical Devices, the Buffalo-based startup developing the biotechnology with assistance from UB’s Buffalo Institute for Genomics and Data Analytics (BIG).

The seed for the innovation — called Biofilm Disruption Device™ (BDD™) — was born in the laboratory of Mark Ehrensberger, associate professor in UB’s Department of Biomedical Engineering, a joint program of the School of Engineering and Applied Sciences and the Jacobs School of Medicine and Biomedical Sciences at UB.

Ehrensberger developed the electrical-stimulation method that Garwood licensed from UB. To bring the technology to market, Garwood partnered with BIG, which is part of Gov. Andrew M. Cuomo’s economic development efforts to further grow Buffalo Niagara as a hub for bioinformatics and life sciences.

Garwood also has been working with UB’s New York State Center of Excellence in Materials Informatics, the UB Center for Advanced Technology in Big Data and Health Sciences, and the UB Center for Computational Research. Additionally, it recently was accepted into Empire State Development’s Technology Transfer Program.

“Garwood has swiftly tapped into the entrepreneurial ecosystem that UB and its partners have created in Buffalo. With their suite of innovative and cost-saving medical devices, they’re poised to become yet another successful life sciences startup from the region,” says Christina P. Orsi, associate vice president for research and economic development at UB.

The BDD™ system includes two electrode skin patches, a machine that generates low voltage electricity and a needle (about the size of a sewing needle) that carries the electricity to the joint replacement.

The needle is inserted into the body until it reaches the implant or metal hardware. The electric stimulation then triggers a chemical reaction at the surface of the implant that produces a surrounding microenvironment that promotes the killing of bacteria.

Tested in animal models, the technology BDD™ is based upon has eradicated up to 98 percent of harmful bacteria associated with joint replacements, Bacon says. The advancement is important, he says, because infections affect roughly 1 of every 100 knee replacements and there is no simple and effective way to treat them.

Often infections prompt the need for replacement surgeries, which cost at a minimum tens of thousands of dollars. And some studies suggest the rate of infections following joint replacements will increase.

“Biofilm Disruption Device™ is an elegant and minimally invasive solution to a growing problem that causes pain and suffering in hospitals across the nation. It also could save the health care system billions of dollars,” says Ehrensberger, who also directs the Kenneth A. Krackow, MD, Orthopaedic Research Laboratory at UB.

In 2016, Garwood closed on a $3.6 million Series A round from investors in Buffalo Niagara. The company is now raising $3 million in a Series B round.

Meanwhile, another round of testing of BDD™ is underway, with the goal of providing the necessary information to win approval from the U.S. Food and Drug Administration when Garwood files its formal application next year, Bacon says.

The new funding will also help Garwood further develop another product, an electronic bandage called EnerAid™.

Like a conventional bandage, EnerAid™ helps to treat wounds. But the device advances medical care by emitting electricity and magnetic pulses that stimulate blood flow to promote healing. It also will connect wirelessly to the cloud, providing real-time information on a patient’s condition to the physician and nursing staff.

The project is a collaboration with Albert Titus, professor and chair of UB’s Department of Biomedical Engineering.