More than two years ago, Deborah Bathgate fell off a ladder and knew something was wrong as soon as she crashed to the ground.
She was right. It turned out she had fractured her humerus, a bone in the upper left arm by her shoulder.
Usually, a bone fracture such as that means months of recovery and limited mobility while the arm stays in a sling, particularly when elderly people are injured. But not for Bathgate, who opted to undergo a procedure using orthopedic medical technology created by East Providence-based IlluminOss Medical Inc.
The procedure is minimally invasive and works by inserting a balloon into the broken bone through an incision and pathway that can be as small as 3 millimeters, says Mike Mogul, IlluminOss board chairman.
Then the surgeon fills the balloon with a specialized light-sensitive resin through a catheter. As the balloon fills, it expands to fill the space inside the bone. A blue optic fiber inserted in the bone then causes the glue to quickly cure, creating a cast of sorts inside the bone, stabilizing it.
Bathgate, who lived in Providence at the time, says she felt almost no pain during or after the procedure and while she still had some limitations during the recovery process, she was still able to return to her daily routines.
“I wasn’t able to drive because I injured my primary arm, but I didn’t have to have skilled workers come in,” Bathgate said. “It gave me a new lease on life.”
IllumniOss is counting on many others feeling the same way in the coming years.
The company – which recently reached the mark of 10,000 procedures using its light-cured implants to strengthen fractured bones in the U.S., the Netherlands and Germany – predicts that its technology will see more demand as the global elderly population grows rapidly over the next 25 years.
According to IllumniOss, about 1.5 million geriatric patients suffer “fragility fractures” that are difficult to treat with conventional methods because of the age of the patient. That’s not the case with IllumniOss technology, executives say.
The company is privately held and hasn’t disclosed its annual revenue publicly. But its potential has garnered attention.
In 2020, private equity firm HealthpointCapital, which focuses on the musculoskeletal sector, took a majority stake in IlluminOss. And last month, House Speaker K. Joseph Shekarchi attended a demonstration of the implant procedure at Orthopedics Rhode Island Inc., which does business as Ortho Rhode Island, in Warwick.
Shekarchi, who last year championed the creation of the R.I. Life Sciences Hub, touted IlluminOss as an example of the economic development potential he envisions for the sector.
Mogul says the idea for the IlluminOss technology came from founder Robert Rabiner, who noticed surgeons using bone cement for procedures such as hip or knee replacements only have a limited time before the material hardens. This means surgeons would have to race against the clock to make sure they set the bone properly.
But because the material in IlluminOss’ technology cures only when exposed to blue light, surgeons can take as much time as they need.
“You don’t really want to have a race,” Mogul said. “Because of the blue light, you’re able to orient and set the fracture before you turn the light on and that way the surgeon doesn’t have any stress when they’re putting the bones back together.”
Then once the bone is set, the blue light takes just minutes to harden so patients can go home the same day.
Mogul says the procedure costs the same as a standard “fracture fixation device,” equipment that typically costs between $3,000 and $4,000. But the main difference with methods used by IlluminOss is that the recovery time is much quicker, company executives say.
In Bathgate’s case, many doctors would have likely advised her to remain in a sling to immobilize her arm for several months, IlluminOss says. Another option for some bone fractures: undergo a more intensive surgery that requires anesthesia and months of rehabilitation.
But with IlluminOss’ procedure, Bathgate says she was back to normal in 10 weeks with regular physical therapy. And now she has fully recovered and has returned to her normal activities, including caring for her young grandchildren.
“I’ll stick by it,” Bathgate said, adding she’s met people who had a similar injury that had to stay in a cast or sling for several months.
While the technology can be used on any adult patient, it works best for those who are 55 years and older, such as Bathgate, who have bone fragility concerns.
“The key for fractures, especially with the geriatric or older population, is getting them moving right away because every day you don’t move is a much bigger atrophy issue,” said Dr. Michael Bradley, orthopedic surgeon and CEO and president of Ortho RI. “These will help patients move right away; they may not lift heavy things, but they can move their arm and use it.”
The technology has been used in Europe since 2010 and in the U.S. since 2018 after securing approval from the U.S. Food and Drug Administration. Now IlluminOss is hoping to expand its reach and help more patients recover from broken bones quicker. The best way to do this is through education, Bradley says.
“We’re really trying to educate emergency rooms, primary care providers and families that there are other options besides immobilization,” Bradley said.