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IlluminOss is no longer a stealth success story in Rhode Island

Successful completion of enrollment in its U.S. clinical trial, with 80 patients at 13 surgical sites, positions the commercial stage firm to receive FDA approval for its innovative bone fracture repair system in the summer of 2017 – and with it, the potential to capture more than half of an estimated $3 billion U.S. market

Photo courtesy of IlluminOss

Manny Avila, the president and CEO of IlluminOss, demonstrates the company's innovative bone fracture repair system.

By Richard Asinof
Posted 7/25/16
The successful full enrollment of 80 patients at 13 surgical sites in the U.S. clinical trial of IlluminOss’s innovative bone fracture repair system, and with it, potential approval from the FDA as early as the summer of 2017, puts the commercial stage firm on a trajectory toward capturing half the estimated $3 billion U.S. market in bone fracture repair.
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EAST PROVIDENCE – Manny Avila, president and CEO at IlluminOss, had just returned from spending a week in Germany, where the commercial stage medical device firm is seeking to expand the market for its innovative, bone fracture repair system in Europe, when he spoke with ConvergenceRI.

In the 10 months since Avila assumed the leadership role at IlluminOss, he has, working in partnership with founder Robert Rabiner, stewarded the company through the successful completion of its first U.S. clinical trial of its innovative bone fracture repair system.

Earlier in the week, on July 18, IlluminOss had announced that it had completed its enrollment in the U.S. clinical trials for some 80 patients at 13 surgical sites around the country, all with impending or pathologic fractures in the humerus, a bone in the arm connecting the shoulder to the elbow, due to metastatic carcinoma.

Feedback from the surgeons that participated in the U.S. clinical trials has been overwhelmingly positive, consistent with results in international use cases, according to Avila.

To date, Avila said, there have been no negative outcomes in any of the U.S. clinical trials. “All the surgeons have been very, very positive. The patients have experienced a great reduction in pain,” he said. “There is nothing that I’ve seen or heard that would impede getting FDA approval.”

Here are testaments from two surgeons who participated in the U.S. clinical trials, talking about the value of the IlluminOss device, taken from the news release:

• “The IlluminOss system is a transformative technology, providing versatility in the way advanced fracture repair can be approached and enabling orthopedic surgeons to extend the functional benefits of surgical stabilization to more patients while also allowing them to preserve the rotator cuff,” said Dr. John Healey, chief of Orthopaedic Service and the Stephen McDermott Chair in Surgery at Memorial Sloan Kettering Cancer Center.

• “We’ve seen that the IlluminOss implant can be a game changer for patients with humeral metastatic disease. This technology allows us to stabilize the bone with less pain, less surgical time, and less difficulty for the patients. We can therefore treat this problem on an outpatient basis in some patients, and can condense treatments fairly dramatically,” said Dr. Richard McGough, chief of Musculoskeletal Oncology at the University of Pittsburgh Medical Center. “I’m very excited by where this can go in the future, pending FDA approval, as I think this technology could allow us to treat conditions we formerly could not, and can offer ways to treat cancer in the skeleton that were previously impossible.”

Next steps
IlluminOss expects to submit its de novo marketing application to the FDA by the end of 2016, once all the data from the surgeries has been compiled, Avila told ConvergenceRI.

“We are looking to get FDA approval by the end of next summer [in 2017],” Avila said. “I believe, based upon the feedback we’re getting from surgeons, we’re very confident about getting approval.”

IlluminOss doesn’t see any competitors in the marketplace for its innovative system of bone fracture repair, a minimally invasive procedure that injects a thin-walled PET balloon infused with a liquid monomer that, when exposed to light delivered within the PET balloon, forms a hardened implant that conforms to the patient’s specific bone.

“We don’t see any new competitors,” Avila said. “We’re competing against metal plates and nails, the current technology.”

The challenge moving forward, once receiving FDA approval, will be to facilitate the change in the way that orthopedic surgeons practice.

“We’re trying to change the way a surgeon treats patients, to try our new methodology,” explaining the focus of the company’s current activities in Europe, focused on Germany and the Netherlands. IlluminOss has another clinical trial in Europe focused on the humerus that is close to wrapping up, Avila said.

To get doctors to try and then adopt the new technology, IlluminOss is seeking to leverage what it calls surgeon-to-surgeon education. “It resonates much better than [messaging] from a company representative or a sales rep,” he said.

Share of the market
Avila told Convergence that the bone fracture repair market in the U.S. is about $3 billion in the U.S., primarily focused on elderly patients who have older, compromised bones.

If all goes well, and IlluminOss receives FDA approval in the summer of 2017, the company’s business projections anticipate being able to capture half of that market in the next few years – about $1.5 billion. “It’s a pretty significant market,” Avila said.

Translated, IlluminOss has the potential to become the next billion-dollar company in Rhode Island.

Focus, focus, focus
That potential is still in the future, and Avila said he remained focused on managing the small company’s efforts around compiling data from the U.S. clinical trials and developing new surgeon education programs in Germany and in the Netherlands.

IlluminOss currently has 12 employees working out of its headquarters and facilities on Waterman Avenue, with no immediate plans to ramp up. “Our biggest effort is to get through the clinical trials. Once we feel that FDA approval is imminent, we will consider hiring sales and marketing people in early 2017.”


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