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The beat goes on at IlluminOss

Two new patents brings IP portfolio to 25 in U.S., 55 in 17 countries around globe

Photo by Richard Asinof

IlluminOss announced it been granted two new U.S. patents last week, bringing its total to 25 patents in the U.S. and 55 worldwide for its innovative orthopedic implant. The company,which is headquartered in East Providence on Waterman Avenue, is about to begin clinical trials for its product in the U.S.

By Richard Asinof
Posted 12/15/14
The success story of IlluminOss is a great Rhode Island story, built upon good science, attention to metrics and outcomes, supported by well-qualified and quality venture sources. The firm, based East Providence, offers a road map that Rhode Island could follow in developing its biomedical industry sector, understanding the long-term process in job creation.
What kinds of machine-shop prototypes, following the Bolt model developed in Massachusetts by Ben Einstein, can Rhode Island invest in to support new startups in the medical device and maker industry sectors? How can the map of Rhode Island’s emerging innovation ecosytem be enlarged to include other areas of the state outside of Providence? What kinds of infrastructure investments are necessary to support the growth of the biomedical research sectors – from wet labs to machine and tool shops? How can the existing educational institutions in Rhode Island – such as RIC, CCRI and NEIT – be leveraged?
As much as the focus by elected officials is always on job creation, with the desire for immediate results and instant gratification, the reality of job creation, particularly in the manufacturing arena, is a long-term endeavor. The success of Alexion Pharmaceuticals in Smithfield, for instance, is built upon more than a decade of hard work translating research science from the lab bench into profitable manufacturing. The promises of job creation made during a political campaign do not easily translate into immediate results. As the 38 Studios debacle demonstrated, there are no silver bullets for job creation and jumpstarting an industry sector. Investing in early childhood education and building healthier communities may prove to be a more successful long-term job creation and economic development strategy for Rhode Island, with good metrics and outcomes.

EAST PROVIDENCE – If Gov.-elect Gina Raimondo wants to discover the secret sauce of how to grow Rhode Island’s economy and create jobs by investing in the emerging innovation ecosystem, she may want to plan a visit to the headquarters of IlluminOss at 993 Waterman Ave., where the firm 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 research and development on site, and its growth has been the result of “a slow and secure rollout,” Robert A. Rabiner, the founder and chief technical officer of IlluminOss, told ConvergenceRI in a recent interview.

The East Providence site had been found with the help of Lawrence Aubin, the president and CEO of Aubin Corporation, a commercial real estate firm, according to Rabiner. Aubin was recently named chairman of the Lifespan hospital system board of directors.

“We were down in Middletown, on the water,” Rabiner said. “I said to Larry [Aubin], we needed to be near the hospitals, and [the location] has to be in Rhode Island, because of a promise I made.”

When the company first moved to East Providence in December of 2008, it had secured an initial 5,000 square-foot space in what then had been a vacant building at 993 Waterman Ave., Rabiner said. As the company expanded, it kept breaking through walls, to add more space. Now, the company’s footprint includes 993, 995 and 997 Waterman Ave.

The success of IlluminOss, with its well-qualified and quality venture funding sources, is a great Rhode Island story, according to Rabiner.

New patents granted
Last week, IlluminOss announced that the firm had been granted two new U.S. patents for its innovative orthopedic implant system, bringing its intellectual property portfolio to 25 patents here and 55 in 17 countries around the globe.

The implant uses a reinforcing agent inside a balloon that is cured by visible light, Rabiner explained. “To our knowledge, we’re the only [firm] in the world that does that,” he said.

In November, IlluminOss officially announced that it had been granted conditional approval by the FDA for clinical trials for its orthopedic implant system to treat impending and pathologic fractures in the humerus – the upper arm bone – due to metastatic carcinoma.

ConvergenceRI broke the story in early October when Rabiner, a participant on a MedMates panel, shared the good news, which he said followed a lengthy seven-year conversation with the FDA. [See link to ConvergenceRI story below.]

Plans are to have the first patient in a U.S. clinical trial site, Rabiner told ConvergenceRI, to be enrolled during the first quarter of 2015.

“We are enrolling sites as we speak,” Rabiner said. “Our clinical folks are busily recruiting, running down sites. [We plan to] have the first patient [enrolled] early mid-quarter in the first quarter in the U.S.”

Rabiner hopes to have a clinical trial site in Rhode Island. “It is our hope and desire that we’ll have Rhode Island Hospital as one of the sites. We are in conversations with members of the Orthopaedic Oncology team over there,” he said.

Metrics and outcomes
The IlluminOss proprietary orthopedic implant system has already been safely and effectively used in more than 700 patients since 2008 internationally. In that time, there have been “zero” infections and only “two” implant removals, Rabiner said at the MedMates event, talking about the importance about developing metrics and outcomes.

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.

It 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.

Repurpose older mills
Rabiner said that he had not been invited to participate in the gathering of 80 or so thought leaders form the private sector by Gov.-elect Raimondo on Dec. 16, and he said he wanted to be careful not to pre-judge the potential outcomes of that conversation.

But, based on his own experience, he did talk about some ideas about growing the economy in Rhode Island.

“With a [startup] medical device company,” Rabiner said, “what you need is a machine shop, you need production facilities.” Many startups, he continued, “are bootstrapping. They don’t’ have the wherewithal.”

Rabiner suggested repurposing some of Rhode Island’s empty mills and old factories and developing them into a hands-on machine shop to do prototype fabrication.

“Utilize some of the folks at CCRI to run it, and you could come in, similar to Betaspring, create a low-cost use of manufacturing so you can make your product prototypes,” he said.

A lot of people who have a good idea, Rabiner continued, “don’t have the cachet or bandwidth to get someone interested that will fund the idea. Prototypes cost money, and it could be big money.” What is needed, he suggested, is access to have that production work done at a low-cost facility.

Strategy for success
IlluminOss appeared to be moving forward on a successful trajectory, but Rabiner expressed cautious optimism regarding the company’s future.

“You cannot be too cautious,” he said. “We are increasing manufacturing, we are hiring more people, nothing crazy, one or two, here and there, to support the product.”

There is no way you can prognosticate what is going to happen tomorrow, Rabiner continued. “I can only do my best every day to move the needle forward, to get the those clinical sites enrolled, to get the sales. The product will speak for itself.”

Rabiner, who is planning to take a vacation next week, noted that on his first day of vacation, he’s going to see a potential clinical trial site in Miami.

Rabiner offered this advice about building a company – and it was advice that Rhode Island might take to heart about the long-term nature of rebuilding its economy.

“When you build a house, you build the house on a foundation,” he said. “And you build it a board at a time; you don’t try to build the second floor before the foundation.”

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