Garwood Medical Devices, LLC

Americans undergo two million knee and hip replacement surgeries annually. Approximately 2.4%, or 50,000 of these patients suffer from implant infection. Orthopedic implant infections are extremely difficult to treat, and the current “Gold Standard” for infection control is painful and costly. Treatment involves reopening the wound, removing the implanted materials and any infected bone, and employing an antibiotic drip for weeks to prevent reinfection. The average cost for each course of treatment, which may last years, is $300,000, for an annual cost of $15 billion nationwide for knee and hip implants alone. With an aging population this figure will only increase — infection incidences are projected to nearly triple by 2030.

Orthopedic implant infections are caused by bacteria that attach and grow on the metal surface of the implant, forming a slime or “biofilm”.  The biofilm itself forms a barrier that protects  the bacteria from antibiotic treatment and the immune system. If the biofilm is actually disrupted by antibiotics it tends to grow back, and “successful” antibiotic treatment can cause bacteria to detach from the joint area, enter the bloodstream, and infect the heart, causing severe complications.

Garwood have exclusively licensed a technology developed by UB researcher Dr. Mark Ehrensberger that can disrupt bacterial biofilms. In partnership with UB they are developing a medical device that can act on any metal implant in the body, with the aim of preventing and treating orthopedic implant infections, reducing patient morbidity and mortality, preventing unnecessary surgeries and saving billions of dollars worldwide per year.

The Biofilm Disruption Device™ (BDD™) is a minimally invasive “electroceutical” medical device that can be used on any metal implant. It utilizes low voltage electrical current in a two-hour treatment that breaks up biofilms, kills bacteria, and stops infections early on before they become problematic.

The BDD forms a circuit that turns the metal implant into an electrode. The voltage creates a chemical reaction at the surface of the implant that rapidly increases the local pH, effectively eradicating the infection on the implant and in surrounding bone tissue.

The seed for the BDD innovation 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. Dr. Ehrensberger developed the electrical-stimulation method that Garwood licensed from UB and continues to support their product development as scientific adviser for the company.

To bring the technology to market, Garwood partnered with the Buffalo Institute for Genomics and Data Analytics (BIG), part of Gov. Andrew M. Cuomo’s economic development efforts to further grow Buffalo Niagara as a hub for bioinformatics and life sciences.

Garwood has also been working with UB’s 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, using computer modeling and electronic engineering expertise to accelerate their product development.

Garwood’s goal is to eliminate the need for follow-up surgeries, wiping out infection-causing bacteria before it starts. Future applications for the technology could include prosthetics and dental implants. Support from UB and Empire State Development has accelerated this technology through the prototyping, proof of concept and preclinical testing stages.

In 2016, Garwood closed on a $3.6 million Series A round from investors in Buffalo Niagara to continue the products development. They are now working on raising $3 million in a Series B round.

Meanwhile, another round of preclinical testing 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.