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The future grows even brighter for IlluminOss

First three patients in clinical trial in U.S. undergo successful surgeries with the firm’s breakthrough technology to repair fractures

Photo courtesy of IlluminOss

Amy Berman, vice president of clinical affairs, demonstrates IlluminOss's new technology to repair bone fracture.

By Richard Asinof
Posted 6/29/15
The successful start of surgeries for patients enrolled in the clinical trials in the U.S. for IlluminOss’s innovative technology to repair bone fractures has been auspicious. It is part of the continuing great story of a Rhode Island firm scaling up in the biomedical industry sector.
When will the mapping of the health innovation ecosystem in Rhode Island emerge as an economic development priority? What are the lessons that can be learned in a comparison of the much-hyped Teespring and its exit from Rhode Island vs. IlluminOss and its long-term investment in expanding its footprint in Rhode Island, creating high-value jobs? How will the changing health care delivery landscape, as it transitions from free-for-service to the age of the ACO, with its redefinition of risk sharing and its promotion of value over volume, change the approach to the new medical device technology pipeline?
So much time, energy, money and political resources have been spent devoted to fighting against gay marriage and attempting to gut Obamacare, two issues that were decided by the U.S. Supreme Court last week. Imagine if all that personal and political energy and money had been spent trying to make things work better, much the way companies within the health innovation ecosystem ask and answer questions about new products and their design.
Decision-making in the digital age is changing; the power brokers can no longer push buttons and get the desired responses, as the Boston Red Sox owners found out when they attempted to push their vision of a new stadium in Providence. Just as the British East India Trading Company discovered 200 years ago [and perhaps companies such as Monsanto are discovering today], engaged communities are changing the landscape about what truths they hold to be self-evident.

EAST PROVIDENCE – The future keeps getting brighter for IlluminOss Medical, a commercial-stage medical device firm, and its minimally invasive technology that can repair fractures “at the speed of light.”

The first three U.S. patients – two at Marshall University Joan C. Edwards School of Medicine, a third at Hackensack Medical Center in New Jersey – have had successful surgeries as part of an ongoing clinical trial underway with 80 planned patients.

The surgeons used IlluminOss’s breakthrough technology – an implant utilizing a light-curable polymer, contained within a balloon catheter – to fix impending or pathologic fractures in the humerus, the upper-arm bone, caused by metastatic carcinoma.

“The patients were completely stable immediately following the procedure and reported little or no discomfort,” said Dr. Felix Cheung, orthopedic surgeon who is chief of the Division of Orthopaedic Oncology at Marshall.

Having seen first-hand how effective the IlluminOss system is, Cheung continued, “I believe the benefits it provides to both the surgeon and the patient have the potential to make it a true game-changer in the way fracture repairs can be approached.”

New sites now enrolled for surgeries as part of the U.S. clinical trial include Memorial Sloan Kettering Hospital in New York, North Mississippi Medical Center in Tupelo, Miss., Rush University Medical Center in Chicago, as well as hospitals affiliated with Duke, Wake Forest, Emory and Ohio State universities, Robert A. Rabiner, the founder and chief technical officer of IlluminOss, told ConvergenceRI in a interview last week.

“We’re about a day or so away from finalization with Rhode Island Hospital,” said Rabiner, praising what he called the team effort at IlluminOss. The only thing remarkable about the three surgeries performed to date, Rabiner added, “was how simple, easy and excited the surgeons were over the use of the product.”

The next threshold for the company is to fully enroll the clinical trial and submit the data to the FDA, hopefully by the early part of next year, Rabiner continued. “Once we get [FDA] approval, we can start to bring this technology to the rest of the medical universe in the United States.”

Good to the bone
IlluminOss is a great Rhode Island success story, a company built upon good science, attention to metrics and outcomes, supported by well-qualified and quality venture sources.

In contrast to much-hyped startup Teespring and its recent, rapid departure from Rhode Island, the IlluminOss story offers a road map that Rhode Island could follow in developing its emerging biomedical industry sector, understanding the long-term process in high-value job creation.

Beginning with a good idea, the commercial-stage firm has evolved through Series A, B, and C venture capital investments. The privately held firm, founded in 2007, 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.

In turn, IlluminOss added new space and new employees at its Waterman Avenue headquarters in East Providence as the firm prospered. IlluminOss has expanded from its initial 5,000 square-foot operating space in 2008 to more than 16,000 square feet today. The self-sufficient facility conducts its own manufacturing and R&D on site. Its growth has been the result of what Rabiner called “a slow and secure rollout.”

As part of its evolution, the firm has also built up the value of its intellectual property. In early December of 2014, IlluminOss announced that the firm had been granted two new U.S. patents for its innovative orthopedic implant system, bringing its IP portfolio to 25 patents here and 55 in 17 countries around the globe.

The IlluminOss proprietary orthopedic implant system has already been safely and effectively used in more than 700 patients since 2008 internationally, principally in Europe. In that time, there have been “zero” infections and only “two” implant removals, according to Rabiner, stressing the importance about developing metrics and outcomes.

The technology has been approved for clinical applications under a CE Mark [the mandatory marking for certain products sold within the European Economic Area] since 2010. 



In addition, IlluminOss has expanded its international efforts with Trimarco in Israel and Cherry Medical Solutions in Austria.

What the innovative technology does
The technology repairs fractures through the implant of a reinforcing agent inside a balloon that is cured by visible light. “To our knowledge, we’re the only [firm] in the world that does that,” Rabiner told ConvergenceRI in a December interview.


As described on the IlluminOss 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

Ramping up
Rabiner told ConvergenceRI that hiring of new employees in the U.S. would be done in relationship to the ramping up of the clinical trials.

“There will be hiring here when we have an approval from the FDA, certainly for a sales organization to promote the product,” Rabiner said. “That’s a little further done the pipeline; it would be premature to make those hires untiul we have a littler more visibility.”

The expansion in Europe continues apace. IlluminOss had just hired an individual to coordinate the firm’s European sales operations, who has 20-plus years experience in international markets, according to Rabiner. In addition, the firm hired a new manager for all of IlluminOss’s German sales.

Rabiner declined to talk about IlluminOss’s success in the context of a more global perspective of the economic development landscape in Rhode Island. “I can only talk about what has happened here at IlluminOss,” he said. “We’re focused on the next patient, the next trial, the next indication.”

Data-driven results
Rabiner stressed the importance of publishing peer-reviewed data on the work being done by IlluminOss.

“It’s important for the medical universe to hear about what we’re doing, so we can align ourselves with key opinion leaders,” Rabiner said.

Looking beyond the U.S. clinical trials, Rabiner said that he was very pleased with the results from the international data – and the potential to use the IlluminOss implant technology to repair fractures “for every bone in the anatomy.”

The potential market in the U.S. will depend on the success of the ongoing clinical trials.

When asked by ConvergenceRI about the potential market for use in sports injuries with professional athletes, once the technology was approved for use in the U.S., given the indications of improved stability and immediate range of motion, Rabiner responded, with a bit of humor: “We would treat all fractures, we would be agnostic, to whom the patients are – should it be the a player with the Patriots, the Red Sox or the New York Yankees, if they happen to have a broken wrist or a forearm fracture.”

Rabiner added, laughing: “We would be glad to take them over to Europe and treat them there now – but that’s a bit of a reach.”

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