Published February 1, 2021
A University at Buffalo partnership with private industry is achieving great impact in the field of prosthetic design.
A team of Jacobs School of Medicine and Biomedical Sciences researchers and Buffalo-based startup Garwood Medical Devices LLC have been awarded $749,000 to evaluate the technology behind BioPrax, their medical device that utilizes UB-licensed technology, and bring it one step closer to clinical use in amputee patients.
The device was created to eliminate bacterial biofilm infections associated with orthopedic implants — a common, costly and potentially devastating problem.
“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,” says Wayne Bacon, president and chief executive officer of Garwood Medical Devices. “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.”
The technology behind BioPrax, a cathodic voltage-controlled electrical stimulation (CVCES), is patented by UB and Syracuse University and exclusively licensed by Garwood. When an infection is present, BioPrax delivers the electrical stimulation to a metal implant, such as a prosthetic knee, where it has an antibacterial effect and kills the infecting bacteria.
“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,” says Mark Ehrensberger, PhD, co-inventor of the CVCES technology and associate professor of biomedical engineering, a joint program of the UB School of Engineering and Applied Sciences and the Jacobs School.
Ehrensberger is also director of the Kenneth A. Krackow, MD, Orthopaedic Research Laboratory in the Department of Orthopaedics in the Jacobs School.
Previous, nonclinical studies have proved the technology to be effective at disrupting biofilms and killing bacteria and showed no deleterious impacts to tissue or bone. In 2019, Garwood received “Breakthrough Device” designation from the U.S. Food and Drug Administration (FDA).
According to the FDA’s website, the Breakthrough Devices Program targets technologies “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” The goal “is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment and review,” the website states.
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,” says Ehrensberger, principal investigator of the study.
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,” Ehrensberger says. “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.”
“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,” he adds. “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.”
Co-investigators in the Jacobs School are:
The team is also collaborating with researchers at the Uniformed Services University and Walter Reed National Military Medical Center.
Since the inception of their idea, Ehrensberger and Campagnari have received numerous grants and awards, as well as assistance with patent filing and licensing agreements, from Business and Entrepreneur Partnerships (BEP).
“BEP provides a full continuum of support to faculty — from grant funding to technology transfer to facilitating contracts and outreach — that enables faculty to partner with industry and advance their innovations to achieve great economic, social and human impacts,” says Christina P. Orsi, UB associate vice president for economic development. “Building a global ecosystem that drives symbiotic partnerships and enables collaborations between researchers, patients, health care providers and life sciences companies is the most effective way to achieve true patient centricity and speed up the development and access to new medicines or devices for patients in need.”
By connecting faculty with industry partners and resources that allow them to focus on their strengths, BEP helps fill in needed gaps to rapidly commercialize novel innovations.
“As a professor, my passion really is pursuing the fundamental and applied research to enhance our knowledge of the science and technology behind this novel antimicrobial therapy,” Ehrensberger says. “Working with Garwood has been advantageous because they’re very much grounded in translating this technology out into the clinic as soon as possible.”
“I’m very confident in their commercialization strategy and their abilities to move the technology forward — with manufacturing and fabrication, testing and navigating the FDA approval pathway — which allows our academic team to focus on the science and developing the next iterations of ideas to continue optimizing this infection control strategy,” he adds.
In addition to business and financial support, Ehrensberger has seen the partnership with Garwood result in something that he says is even more fulfilling — jobs for his students.
Bacon, president and CEO of Garwood, says, “In addition to having licensed the valuable technology behind BioPrax, we hired brilliant employees from the same UB lab, including our lead scientist, Mary Canty, PhD, and biomedical engineer Jackson Hobble. They are directly participating in translating their research into a highly valuable device and treatment.”
“I would love to see this technology make it into the clinic and positively impact patient care. I think that is what everyone who is involved with this project rallies around,” Ehrensberger says. “It would be a very fulfilling culmination of an idea that our collaborative team started working on over 10 years ago.”