When it comes to treating deep tissue and bone infections, solutions are hard to come by and often even harder to administer.

Lyn Markey aims to change this. The co-founder of Xtremedy Medical, an NUI Galway-based medical device firm, believes the non-thermal device pioneered by her company can improve outcomes for patients and surgeons alike.

She and Camille O’Malley jointly established Xtremedy in 2020 after undertaking NUIG’s BioInnovate Fellowship, which aims to find new therapies for underserved or hard-to-treat health problems.

“During that period, we would go into surgeries and clinics and try to find unmet needs,” Markey recalled. “And Camille and I spent a good few months in orthopedic surgeries throughout Ireland trying to figure out what problem we wanted to solve. And the one that stuck out to us was bone infection.”

Xtremedy’s directors picked an important area to focus their attention on. Bone infections are complex, given that they often require treatment of deeply buried tissue. It’s a difficult area to reach, and the antibiotic and surgical interventions used on infections like osteomyelitis are often ineffective.

“Antibiotics can’t get to the bone, and surgeries often don’t work, meaning patients can spend months in and out of hospital in a devastating process,” Markey said. “Neither has proven to be clinically beneficial.

“Where our approach is different is that we use electrical signals that treat the surface and below the surface without disrupting the integrity of the wound. So you don’t have that problem of spreading the infection deeper and you are effectively zapping the infection that is there.”

The device invented by Xtremedy, which has backing from Enterprise Ireland, is disposable and easy to use, and could help reduce the number of patients in hospitals by improving surgical outcomes in the space.

It will eventually be sold to hospitals, Markey noted. “Surgeons will be our customers.”

But there’s a long road ahead for the company: it could take up to six years before Xtremedy gets approval to roll the treatment out in the US, where it plans to start out.

“We can hit the ground running once we get regulatory approval, and we’re looking at the American market initially,” Markey said. “But authorisation from the Food and Drug Administration (FDA) might not come until 2027.”

In the meantime, the product will have to jump through a number of hoops in prototype form, culminating, Markey said, in a pivotal clinical trial within five years.

To get to that stage, the company is seeking to raise €3 million by the first quarter of 2022, in a fundraise that will help pay for the trials as well as key new hires.

“Infection is a huge, huge market,” Markey said. "And there’s a huge opportunity out there for Xtremedy to meet the need in this huge market. Our next focus is to prove the product is safe in humans, and then to prove ourselves in a pivotal clinical study. From there, we want to get the devices out to patients, and really improve patients’ outcomes for them.”

Reporting: The Business Post