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IlluminOss gets FDA OK to move ahead with clinical trial

News shared at MedMates get-together

Image from IlluminOss website

IlluminOss has been approved for clinical trials by the FDA for its bone fracture repair product.

By Richard Asinof
Posted 10/13/14
IlluminOss, the medical device firm based in East Providence, received FDA approval for clinical testing of its bone-fracture product last week. The news was shared at a MedMates gathering at Betaspring.
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PROVIDENCE – Call it serendipity. Robert A. Rabiner, founder and chief technical officer at IlluminOss, was asked to be part of a panel at MedMates held at Betaspring on Wednesday, Oct. 8, part of a series focused on “journey of a health tech startup.”

The panel discussion, first in a series, was conceived as an interactive story-telling session by CEOs, following the narrative of “ideation > organization > funding > traction > exit.”

A crowd of about 100 – including many students who were attending a MedMates event for the first time – got to hear the breaking news about a Rhode Island success in the bio-medical industry sector.

That morning, in culmination of what Rabiner described as a seven-year “conversation” with the U.S. Food & Drug Administration, IlluminOss received the go-ahead for a clinical trial for its minimally invasive bone fracture repair system, using photodynamic orthopedic implants, which it markets as “fracture repair at the speed of light.”

As a result, Rabiner had quite a story to share: the evolution of a Rhode Island company, from an idea through Series C venture funding, that was poised to be able to fully enter the market with its product – moving from investigational devices to being approved for sale in the U.S., if the clinical trial outcomes were successful.

The privately held company, founded in 2007, is headquartered in East Providence, and is funded by Foundation Medical Partners, New Leaf Venture Partners, Tekla Capital, Life Sciences Partners, Excel Venture Management, SR One, Longwood Fund, Pappas Ventures, Mieza Capital, and the Slater Technology Fund.

As described on its website, “The minimally invasive IlluminOss Photodynamic Bone Stabilization System is used to treat fractures through a small entry into the bone. A flexible balloon catheter is inserted into the bone, placed across the fracture site, and infused with a proprietary liquid monomer [a molecule that can bind chemically to form a polymer]”

The liquid monomer then expands the balloon, the description continued, “to assist in the alignment of the fractured bone.” Surgeons then use a visible light source to illuminate it and convert it into a hardened polymer implant – similar to dental cement. “The result is an exceptionally tough, customized orthopedic implant that provides strength and stabilization to the bone during the healing process,” the website description said.

The process achieves a customized, immediately stable implant, giving patients near-immediate rotation stability, according to IlluminOss.

Good to the bone
In a conversation with ConvergenceRI the next day, following the event, Rabiner briefly sketched out of some the details of the upcoming clinical trials, which will focus on bone fractures and impending fractures related to cancer. He said that no news release is planned until after he gets back from Europe in mid-November.

With clinical trials approved, the effort shifts to developing agreements with hospitals, he explained. Rabiner said he hoped to be able to develop a clinical trial site at Rhode Island Hospital, working with Lifespan. “I hope that they will participate,” he said, adding that other places under consideration are cancer centers across the country.

In terms of timing, Rabiner said that he expected it would take three to four months of a start up process and recruitment process, with the hope that the trials would commence during the first quarter of 2015.

At the MedMates event, Rabiner talked about the importance of developing metrics and outcomes. Since 2008, IlluminOss had done implants in about 700 patients. In that time, there had been “zero” infections and only “two” implant removals.

As a result, in the FDA’s letter granting approval of the clinical trials, there were few if any questions regarding the safety and the technology, according to Rabiner.

Rabiner said that the success of IlluminOss, with its “well-qualified and quality” venture funding sources, is a great Rhode Island story.

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