Garwood Medical Devices recently announced that it and a University of Buffalo research team have won a $749,000 federal grant to evaluate a medical device to prevent, control, and eliminate bacterial biofilm infections associated with orthopedic implants.

Garwood is licensing the technology behind the BioPrax device, a cathodic voltage-controlled electrical stimulation (CVCES) patented by the University of Buffalo and Syracuse University. When an infection is present, BioPrax is designed to deliver the electrical stimulation to a metal implant, such as a prosthetic knee, where it has an antibacterial effect designed to kill the infecting bacteria.

“Metallic implants, such as knee and hip replacements, are prone to getting antibiotic-resistant biofilm infections, which are nearly impossible to cure without removing the implant altogether,” said Garwood Medical president & CEO Wayne Bacon in a news release. “After removing orthopedic implants, there is a high percentage of failure to ever re-implant another joint replacement, costing patients and the health care system tens of billions of dollars per year and leading to many joint fusions, amputations and deaths.”

“We believe this novel infection control strategy has the potential to introduce a paradigm shift in the treatment of orthopedic implant-associated infections (IAIs), as it would allow for effective treatment without having to remove the implant, thereby maintaining biomechanical stability and mobility of the body segment and reducing the morbidity and mortality rates associated with recalcitrant IAIs,” added CVCES technology co-inventor and orthopedic researcher Mark Ehrensberger, an associate professor in the University of Buffalo’s Department of Biomedical Engineering.

Garwood Medical raised $4 million in August to fund preclinical studies that it says have shown the technology to be effective at disrupting biofilms and killing bacteria and showed no deleterious impacts to tissue or bone. The company received FDA breakthrough device designation for the technology in 2019.

The new grant funding, awarded by the Peer Reviewed Orthopaedic research program of the Congressionally Directed Medical Research Program, will enable the multi-institutional team to investigate a potential new clinical application for the BioPrax technology. The main goal of the study is to “evaluate in a large animal model how the therapy behind Garwood’s BioPrax system can be used to enhance wound healing and infection control at the percutaneous site of osseointegrated prosthetic limbs,” said Ehrensberger, principal investigator of the study. The team is also collaborating with researchers at the Uniformed Services University and Walter Reed National Military Medical Center.

An osseointegrated prosthetic limb is a new type of artificial limb that is directly anchored to the bone within the patient’s residual limb. According to Ehrensberger, these devices can be particularly beneficial to amputee patients with a short residual limb or soft-tissue challenges that limit traditional socket prosthetic use — challenges often associated with military combat amputees.

“Osseointegrated prosthetic limbs offer promising advantages and improvements over the currently-used socket prosthetic limbs, including direct load transfer to the skeleton, better control of prosthetic movement, and potentially the return of some sensory function. However, the widespread utilization of this prosthesis has been guarded due to concerns of infection originating at the site where the titanium implant protrudes through the skin,” Ehrensberger said. “We believe when infection risk is minimized and soft-tissue healing is promoted, osseointegrated prosthetic limbs can lead to functional independence for patients who cannot otherwise tolerate a prosthesis. Enhanced infection control and tissue-integration with CVCES could allow amputees to realize the full potential of osseointegrated prostheses and improve their quality of life.”