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Breaking News: IlluminOss granted FDA OK for its innovative bone stabilization system

The Rhode Island-based commercial stage medical device firm is now ramping up to market the product in the U.S.

Photo courtesy of Robert Rabiner

The IlluminOss bone stabilization system being used in a surgical setting to repair a bone fracture.

By Richard Asinof
Posted 1/9/18
IlluminOss, a privately held, commercial stage medical device firm in East Providence, recently received approval from the FDA for marketing clearance for its innovative bone stabilization system. The approval was announced at the 2018 J.P. Morgan Healthcare Conference in San Francisco.
What lessons can be learned about how best to invest and grow the innovation economy in Rhode Island based upon the experiences of IlluminOss? Would the 10-year negotiation process with the FDA to receive a de novo marketing clearance provide an excellent case study for business universities in Rhode Island? What are the metrics of success in putting patient outcomes first in terms of priorities? Can the seed investment model practiced by the Slater Technology Fund be replicated?
How best to nurture the formation and growth of industry clusters in Rhode Island remains a bit of a conundrum. First, defining the proper interaction between industry clusters and state government often appears to be problematic, revolving too much around funding opportunities. Second, developing a working relationship across state lines, working with industry clusters from either Connecticut or Massachusetts in a regional approach, often runs into competitive, chauvinistic barriers. Third, the focus is often on job creation as the defining metric, rather than the long-term value of the innovation process – which often goes through a series of failures before achieving success.

EAST PROVIDENCE – Call it making a big splash. On Tuesday morning, Jan. 9, at the 2018 J.P. Morgan Healthcare Conference in San Francisco, IlluminOss announced that the U.S. Food and Drug Administration had granted the privately-held, commercial-stage Rhode Island medical device firm “de novo marketing clearance” for its innovative bone stabilization system.

The FDA approval, which was officially granted on Dec. 19, 2017, is the first time that the federal agency has ever granted a de novo marketing clearance for an orthopedic medical device, according to Robert Rabiner, chief technology officer at IlluminOss.

“The IlluminOss Photodynamic Bone Stabilization System is indicated for skeletally mature patients in the treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease,” the FDA approval read.

The approval for the minimally invasive orthopedic fracture repair system followed the successful completion of U.S. clinical trials in 2016, in which 81 patients were treated. Among the findings were that patients experienced less pain, had better mobility in recovery, and had quicker discharges from the hospital, according to Rabiner.

“There is critical need to make less invasive orthopedic fracture repair options available to an aging and underserved market segment,” Rabiner said, in the news release accompanying the announcement.

A local orthopedic surgeon at Rhode Island Hospital, who was a participant in the clinical trials, shared his opinions with ConvergenceRI about how the IlluminOss system had improved patient experiences and outcomes.

“The IlluminOss system is less invasive than a conventional metal rod,” said Dr. Richard M. Terek, professor of Orthopaedic Surgery at the Warren Alpert Medical School at Brown University and an attending surgeon at University Orthopedics. “The amount of pain after surgery seems less and the recovery is quicker, especially since the device can be placed in the bone without affecting the rotator cuff.”

How it works
The IlluminOss system was developed with the aim to provide improved patient experiences and outcomes, according to Rabiner. “Our product works exceptionally well in poor quality bone,” he explained. “And, there are no other products out there today that are designed to treat poor quality bone.”

As described in the news release, “the minimally invasive IlluminOss system incorporates a thin-walled PET balloon that is infused with a liquid monomer and then delivered into the intramedullary canal of the bone, through a small incision.”

“Once the balloon is infused with monomer, it conforms to the shape of the patient’s specific bone,” the description in the news release continued. “The surgeon then activates a light source that delivers visible light to the PET balloon, polymerizing the monomer. The cured, hardened implant provides longitudinal strength and rotational stability over the length of the implant, stabilizing the fracture.”

Ramping up
With the FDA approval, IlluminOss is now cleared to market its bone stabilization system in the U.S. for the surgical treatment of impending and actual pathological fractures of the humerus, radius and ulna arm bones. [The IlluminOss system has been available in international markets and been in clinical use since 2010.]

The initial potential global market for the IlluminOss bone stabilization system is the roughly $100 million that is spent on repairing pathological disease fractures, according to Rabiner.

IlluminOss is planning to apply to the FDA for approval of a second indication for a more liberal use of the bone stabilization system later in 2018, submitting data from clinical trials conducted in Europe, according to Rabiner. Pending further FDA approval for the second indication, it could potentially open up the market for an additional $600-$700 million opportunity.

What a long, strange trip it’s been
For Rabiner and his team, the long journey began in 2006, when the company was literally started “in the basement.” The first investment money was received in 2007. The company first began working with the FDA in 2008 to garner approval for its bone stabilization system. The FDA approved U.S. clinical trials in 2014, which were completed in 2016.

During the last year, Rabiner said that the company had been placed in a kind of abeyance, awaiting FDA approval. “We had shuttered the company for all intents and purposes and held it with a slow beating heart to preserve the burn rate, because we were waiting for approval,” he said.

Now, Rabiner continued, the company has taken in new funding from existing investors to finance the commercialization of the product in the U.S. market.

“We are hiring back staff, we’ll be hiring commercial folks, we’ll be hiring sales people, and we can say: coming soon to a hospital near you – Rhode Island Hospital, for example.”

Reflecting on the more than decade-long journey for IlluminOss to reach this threshold, Rabiner said: “It’s not been a sprint, it’s been a marathon. But we’re crossing the finish line.”

The product, he continued, speaks for itself. “Everything we said the product would do, it has done. It is a simple procedure; it provides patients with significant benefits.”

Rabiner was adamant that his intention is for the company to stay headquartered in Rhode Island and to stay at his current East Providence location on Waterman Avenue. “We’re staying. We’re staying in Rhode Island.”

Here is the ConvergenceRI interview with Robert Rabiner, chief technology officer at IlluminOss, and with Fred Tobia, vice president of Regulatory and Clinical Affairs at IlluminOss, following the FDA approval for the firm’s innovative bone stabilization system.

ConvergenceRI: Congratulations on receiving FDA approval. It’s been a long, hard road you’ve traveled to get here.
Thanks. We started the company in 2006 in the basement. We took our first money in 2007. We’ve been working on it ever since.

ConvergenceRI: It was four years ago, in 2014, when you received approval from the FDA to go ahead with clinical trials in the U.S. Is that correct?
Yes. Subsequent to that, we did a clinical trial in the U.S, for the use of the product in treating metastatic disease patients – patients with cancer – in the upper arm. We did a trial with 81 patients; the trial concluded in June of 2016, and we made our submissions to the agency at the end of December in 2016.

And, a year later, we got the approval.

ConvergenceRI: Was this an early Christmas present?
The concept of George Bailey [from It’s a Wonderful Life”] and the little bell ringing [when an angel gets his or her wings] was not lost on a lot of people. Every time a bell rings, the FDA issues a de novo.

ConvergenceRI: What are your core messages moving forward?
The core message has always been the same. The product in the European field has been used for all types of fractures. The results of the use in Europe have been extraordinarily positive.

The product has a prime resonance with osteoporitic poor bone quality patients, because of the manner in which the product works. It works exceptionally well in poor quality bone. And, there are no products out there today that are designed to treat poor quality bone.

Poor quality bone in osteoporosis and metastatic disease are probably the two best examples.

ConvergenceRI: I look up at your whiteboard and see: less pain, faster discharge, and faster better mobility. Are those the results from the U.S. clinical trials that you will be emphasizing in marketing?
In the U.S. clinical trials, we were able to show that patients had a faster return to pre-operative mobility; and we were able to show that there was significant reduction in pain.

ConvergenceRI: What does “de novo marketing clearance mean?
For most products reviewed, the typical pathway is what’s known as a 510K product. The whole idea is that you compare yourself to something else that is currently marketed.

For example, that’s a pen in blue, that’s a pen in black.

But sometimes, there is not an exact predicate. Congress actually came up with the idea of a “de novo” product, something that doesn’t have a predicate device. It has been on the books for more than 10 years.

It’s a way to get a product approved that doesn’t have a clear predicate. But, once approved, it establishes a predicate for future iterations of the product.

So, going back to the example, we went from a blue pen to a black pen; now we have a pen that writes when you talk to it.

ConvergenceRI: How many de novo applications have been approved by the FDA?
We can answer for the orthopedic group – one. Ours is the first orthopedic de novo.

ConvergenceRI: Ever?

TOBIA: Ever.

RABINER: Interestingly, we got a note back from the FDA indicating that they appreciated our fortitude in hanging with them over this period of time from 2008, because they said that they had learned a lot about doing a de novo as well.

ConvergenceRI: With the 81 patients in the U.S. clinical trials, did you have any failures? Were they all a success?
There were no failures. The long and the short of it is, by virtue of using a small incision, and then being able to grow large within the bone, it reduces pain, because [when using our system], the only procedural pain is from doing the incision to the skin, and not making a pathway into the bone.

Think about like a [model] ship going into a bottle, it goes in small and then gets big.

ConvergenceRI: How does IlluminOss plan to ramp up for commercialization?
For the last year and a half, the company was literally on hold. We had shuttered the company for all intents and purposes; we held it with a slow beating heart to preserve the burn rate, because we were waiting.

We have now taken in new funding to commercialize the product in the U.S. We are hiring back staff, we’ll be hiring salespeople, and we can say, coming soon to a hospital near you. Rhode Island Hospital, for example.

ConvergenceRI: Sorry to repeat the question, but just to be clear: was there any negative feedback you received from the U.S. clinical trial.
No. What is interesting was that the trial had been supported by the MSTS, the Muscular Skeletal Tumor Society. They didn’t endorse the trial, but they were certainly positive about it.

ConvergenceRI: As you ramp up, what are the challenges you face?
The challenge is that now we have to put together a product, manufacture it, release it and sell it. We’re already prepared from a regulation standpoint, because we have a CE mark [certification that there is conformity with the health, safety and environmental protection standards for products sold within the European Economic Area] and we’ve been audited every year.

ConvergenceRI: You are one of the few companies that I know about in Rhode Island that has gone from a good idea to a start up to an early stage and then to commercial stage company, raised the money, gotten FDA approval for product, and you’re staying in Rhode Island?
We’re staying. We’re staying in Rhode Island. Granted, no one from the state seems to know about us, but that’s OK.

ConvergenceRI: Would you consider yourself as a poster child, or not, for what it takes to get it done, to succeed?
[laughing] The question is: how many children are there? We’re a bunch of stubborn New Englanders. And, we were going to get this thing across the goal line, even if it killed us, and it damn near did.

ConvergenceRI: So the keys to success are perseverance, stubbornness, keeping your eyes on the prize, and trusting in yourself?
We are very focused. The difference is, we had the opportunity to see this product work for a number of years in Europe, and see the phenomenal success it had with the patients.

We saw that this product worked, it worked well, and it gave benefits to the patients. At the end of the day, that’s why we were doing this.

And so, every time we got knocked down or delayed, the comment always was, within the company: we can’t let this fail, it’s too good of a product.

TOBIA: That’s true.

RABINER: There was a little bit of Quixote and jousting at windmills, too. The only way that this story was going to be told was to get the approval from the FDA, and with that approval, we can bring this product to market.

The market will now discern whether we were stubborn, foolish or prescient.

ConvergenceRI: The new money that you’ve brought in for commercialization, is that through more equity investment?
We have been at this a long time. We have some very focused and stubborn investors. They’ve seen the results of the clinical trials, they’ve seen the results of the patient profiles in Europe, and they believed that this product deserved a chance to be brought to market.

Look, it has not always been pleasant when you have to go back and say: “Dad, I need more money.”

ConvergenceRI: Is it the current investors in the company who have agreed to invest more money?

ConvergenceRI: Is it possible that IlluminOss could move toward an IPO?
One would be foolish to say yes or no at this point. An IPO typically assumes a far greater commercial footprint and revenue stream [than we have]. It would be foolish to say no to any of those things. You don’t know.

Where this company probably resides best is as a fold-in to one of the larger orthopedic or other medical device companies in the world. While we could probably be a very profitable stand-alone company, we would probably be more successful buttoned and folded into a [business] whose main product is purely orthopedics. There are lots of options.

ConvergenceRI: Is there a gap in the current Rhode Island innovation ecosystem?
We don’t have venture money, with the exception of Slater Technology Fund. There’s no money. And, there’s no mentorship.


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