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Healing fractured bones can be a messy business. Surgeons often employ a toolbox of metal rods, plates, screws and nails to align and stabilize fissured bones. The difficulty of the task worsens with aging or osteoporotic bones.
IlluminOss Medical Inc. in East Providence is rethinking the way fractured bones are repaired, with an emphasis on minimally invasive techniques.
“We were trying to find a new way to do what they were currently doing,” said IlluminOss Medical founder Robert Rabiner. “We started doing surgeries for broken fingers in the hand.”
IlluminOss Medical developed a system it calls Photodynamic Bone Stabilization, in which a tightly packaged balloon catheter is inserted through a 5 or 6 millimeter hole drilled into the medullary canal of the fractured bone. Once inserted, the balloon is inflated with a light-curable glue the consistency of thin honey. As the balloon fills, it forms to the individual shape of the canal and assists in the alignment of the bone fragments, setting the pieces in place. Surgeons then switch on a small light connected to a fiber within the balloon catheter, and the glue inside the balloon hardens into a solid material in a matter of minutes.
Gene DiPoto, vice president of research and development at IlluminOss Medical, said to think about the system as “angioplasty meets dental cement.”
“Because it goes in a very tiny incision in a tiny bone hole that we can then fill up and solidify almost instantaneously, our device doesn’t have to be a big solid rod,” said DiPoto. “It aligns the fracture, and the body can start to heal itself.”
The traditional approach to fixing fractured bones often requires large incisions, scraping away of muscle and tissue surrounding the bone, and adhering metal rods and plates onto the bones with screw or nails. There is a risk of soft-tissue injury and collateral damage to nerves, tendons and muscles in the process. This, in turn, can significantly increase the discomfort of the patient, the recovery time and the potential for permanent damage.
IlluminOss Medical built a minimally invasive system that improves the techniques in which surgeons tackle fractured bones, with an emphasis on getting patients, of all ages and robustness, back to their normal activities with less downtime and immobility after surgery.
The balloon is made of polyethylene terephthalate, or PET, which is used in other medical devices, such as sutures or vascular grafts. “The body loves that material,” said DiPoto.
If IlluminOss Medical is successful, it will represent one of the first major achievements in individually customized orthopedic implants. “Implants mounted on the outside of the bone are more uncomfortable to the patient than on the inside of the bone,” said Rabiner.
IlluminOss Medical’s goal is to design a device that will improve patient outcomes by reducing scarring and the traumatic impacts of more invasive surgeries.
“You’re seeing our patients getting back to life sooner, because there is less pain from an incision and as a result they move faster,” said Rabiner.
Over the last four years, IlluminOss Medical implanted its device inside the collarbones, legs, ankles, elbows, forearms and hands of 200 patients throughout Europe. During that time, the company says, it has found no device-related complications.
“We follow all of our patients, and they all have done exceptionally well,” said Rabiner, who said IlluminOss Medical is working with the U.S. Food and Drug Administration toward starting studies in the United States.
Before launching the device in a number of European countries, IlluminOss Medical thoroughly trained surgeons on how to use it. The company said the design is intuitive, so there is a short learning hurdle for surgeons. Once they know it, surgeons choose to use the system over more traditional methods, the company said.
“It’s been fantastic. Everybody gets it. Everybody understands it,” said DiPoto. “They all say this is the way it’s going to go. I think in a lot of cases, they think this solves a problem where they thought there is no other solution.”
DiPoto specifically pointed out that the device could be the most helpful in older patients with osteoporotic bone. “One of the treatments we are proud of occurred in Germany. We had an older woman with an ankle fracture, and she was walking the next day,” said LeeAnn Ali, IlluminOss medical director of clinical affairs. She compared that patient to her own aunt, who suffered from a similar ankle fracture in August. Although the women were approximately the same age, Ali’s aunt was placed in a walking boot with no intervention. Just months later, “she’s still using a walker and has gone from completely independent to needing assistance with just about everything,” Ali said.
“When you think of the impact if this treatment was available, it’s really staggering,” said Ali.
Complications can happen fairly quickly. “If a device doesn’t work a few times, a doctor isn’t going to use it again. In the places where the device is being used, it’s being used in their standard toolkit. That indicates to us that doctors are pleased with its performance and the patient is pleased as well,” said Ali.
While IlluminOss Medical is in the midstages of its corporate development, the ability to repair bones from the inside out could potentially tap a $3.8 billion segment of the orthopedic market.
Douglas Moore is a research scientist at Rhode Island Hospital in the orthopedics department and conducts very early pre-clinical testing with new medical devices.
When Moore learned about what IlluminOss Medical was designing, he was impressed. “The device is very novel and interesting,” he said. “And there is broader applicability. You just look at the technology, and you realize it can be done in different shapes and different places in the body.”
The device could be especially useful in bones that are curved and difficult to jigger a metal plate around.
IlluminOss Medical recently secured $28 million in financing from investors. Previously, the company raised another $22 million in venture capital funding.
The company hopes to continue to develop collaborative relationships with other companies, hospitals and schools throughout Rhode Island and to hire students from Rhode Island universities and colleges as it expands. IlluminOss Medical has 16 full-time employees.
In 2007, Rabiner received Providence Business News’ Innovator of the Year Award for his idea of the IlluminOss Medical Orthopedic System. Two years later, he was awarded the Innovation of the Year in the area of health care. •