Speedier fracture recovery gets step closer in U.S.

FIXING THE ISSUE: the soft-tissue trauma caused by the invasive surgical methods to fix broken bones are extremely slow to heal and dramatically affect [people's] ability to function on their own,
FIXING THE ISSUE: the soft-tissue trauma caused by the invasive surgical methods to fix broken bones are extremely slow to heal and dramatically affect [people's] ability to function on their own," said Illumin-Oss founder, President and CEO Robert A. Rabiner. / PBN FILE PHOTO/ RUPERT WHITELEY

IlluminOss technology that offers “fracture repair at the speed of light” may soon be available in the United States after nearly a decade in the works.

The East Providence company, which has offered what it calls its minimally invasive orthopedic fracture-repair technology in Europe since 2010, is in the midst of clinical trials in the United States. The trials are expected to wrap up in the first half of next year.

Fifteen Lightfix trial sites have been established around the country, and the focus is specific to impending and actual pathologic fractures in the humerus due to metastatic carcinoma, although the IlluminOss implant can address all types of fractures in various bones, according to IlluminOss founder, President and CEO Robert A. Rabiner.

Once trials conclude, the company will then seek approval from the U.S. Food and Drug Administration to launch its technology here, he said. In fact, the first two U.S. patients recently were treated through Marshall University Joan C. Edwards School of Medicine, in collaboration with Cabell-Huntington Hospital in West Virginia.

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The technology uses a light curable monomer that is introduced within a PET (polyethylene terephthalate) balloon to provide fracture repair and stabilization to the bone. It offers patients with an implant that hardens almost instantly for “virtually immediate bone stabilization,” Rabiner said.

The IlluminOss system is an alternative to the current standard of metal hardware used – plates, screws and rods, he explained.

“As we may have observed in our aging parents, grandparents and other relatives, the soft-tissue trauma caused by the invasive surgical methods to fix broken bones are extremely slow to heal and dramatically affect [people’s] ability to function on their own,” Rabiner said.

The IlluminOss system, he said, “can dramatically improve the recovery time for these patients, offering them a quick return to normal activities” – and without the hindrance of a hard cast.

Rabiner said they have received “overwhelmingly positive feedback” based on the system’s use in Europe, where more than 1,000 patients have been treated.

Rabiner said because this is a new approach to fracture repair, they are still educating the market so they do not expect to replace “conventional” orthopedic surgery methods “for decades and decades.”

“As we continue to validate our technology and get the word out we think the advantages of our approach will speak for itself,” Rabiner said.

The company, which recently closed the last tranche of the $40 million round of venture funding that began in September 2012, is funded by Foundation Medical Partners, New Leaf Venture Partners, Tekla Capital Management, Life Sciences Partners, SR One, Longwood Fund, Excel Venture Management, Pappas Ventures, Mieza Capital and the Slater Technology Fund.

“It’s the stealth story in Rhode Island’s innovation economy,” said Richard Horan, managing director at the Slater Technology Fund, which provided $500,000 during the company’s Series C funding round.

Horan said the IlluminOss system could have a “potentially revolutionary impact on the orthopedic-device space.”

The company has approximately 30 employees. Rabiner said that in June, he hired a vice president of sales for Europe, a new position filled by Clive Ridgwell. He expects to hire more staff as the company moves toward commercialization of its technology here. Sales and customer service are areas that should see additional staff, he said.

In addition to growing employees, the company has expanded its facility several times. Initially, it was based in Middletown, where the early research and development was conducted in an approximately 1,500-square-foot space. IlluminOss moved to East Providence at the end of 2007 and now occupies 20,000 square feet, Rabiner said.

The company has seen several management changes over the years, as president and CEO Scott Rader was terminated in 2012 after five years. At the time, Rader said the company was looking for someone with more sales and marketing experience.

He was replaced approximately six months later by Dirk M. Kuyper, who served for 18 months until his departure in September 2014.

Rabiner said hiring a new CEO is not the priority – the focus instead is on the clinical trials and securing U.S. product approval.

“IlluminOss currently has a strong team to lead these efforts,” he said. •

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