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IlluminOss names Manny Avila as its new president, CEO

Avila takes the helm with IlluminOss, on the verge of commercialization of technology with the potential to capture more than a third of $3 billion of fracture repair market in U.S.

Courtesy of IlluminOss

Manny Avila, the new president and CEO at IlluminOss Medical, demonstrating the firm's innovative technology for fracture repair.

By Richard Asinof
Posted 10/12/15
IlluminOss Medical has chosen Manny Avila, born and bred in Rhode Island, to serve as its president and CEO and lead it to the planned commercialization of its revolutionary technology in 2017. IlluminOss is poised to capture a $1.4 billion share of a $3 billion market in the U.S. for treating internal fractures, according to Avila. The potential success of IlluminOss positions the medical device firm to become the next billion-dollar company in Rhode Island.
How will the success of IlluminOss be reflected in the analysis underway by The Brookings Institute to determine Rhode Island’s future economic strategic direction? What are the lessons to be learned from the way that Robert Rabiner has successfully guided the company, attracted venture capital, negotiated with the FDA, expanded the facilities at his East Providence location, and recruited top talent? How can the growing potential of the biomedical sector in Rhode Island be quantified in a way that doesn’t rely on traditional, out-of-date 20th-century metrics?
The opportunities and the risks of launching compelling biomedical ventures in Rhode Island have now fallen under the cloud of bad karma from the 38 Studios debacle and the yet-to-be explained demise of Nabsys. Former Gov. Donald Carcieri pitched 38 Studios as a state investment to jumpstart an entire industry sector; it was a terrible premise. Gov. Gina Raimondo promoted Nabsys as a job-creation enterprise to showcase her business investment acumen; the company recently closed its doors, as 80-90 percent of all start-ups do, a risk that was not identified in her ads.
The success of IlluminOss Medical and the newly name Luc Therapeutics tell a much different story about Rhode Island and its innovation ecosystem, one that is not well understood within the current political discourse. Rhode Island is capable of creating and nurturing world-class companies that, in turn, can attract venture capital investments to take them to scale, focused on health innovation.
Elected officials need to better understand that life cycle. Instead of putting their own projected expectations onto such emerging firms, they need to learn more about how to build and nurture Rhode Island’s innovation ecosystem to support these emerging firms and enable them to succeed, on their own terms.

EAST PROVIDENCE – IlluminOss Medical, the commercial-stage medical device company now in the midst of its first U.S. clinical trial for its revolutionary orthopedic fracture repair product, anticipates it will begin launching and selling its product in the U.S. in 2017, according to Manny Avila, the newly hired president and CEO at the firm.

The success of the IlluminOss system of bone stabilization, a minimally invasive technology which uses a light-curable polymer and is contained within a expandable balloon catheter, is poised to propel the company to capture about a $1.3 billion share of the $3 billion market in the U.S. for what’s known as “internal fixation,” Avila told ConvergenceRI in a recent interview, according to the firm’s business projections.

Translated, IlluminOss is on the verge of becoming Rhode Island’s next billion-dollar company, with Avila at the helm, directing the commercialization.

When that occurs, IlluminOss will no longer be what Richard Horan, senior managing director at the Slater Technology Fund, has termed “the stealth success story” in Rhode Island’s biomedical industry sector.

The recent clinical trials in the U.S. now underway have been documented in a series of stories in ConvergenceRI over the last year. [See links to ConvergenceRI stories below.]

Avila, who is a local Rhode Islander, born and bred here, attending La Salle Academy and then the University of Rhode Island, brings with him more than 20 years as an executive in the medtech industry, including senior positions at OmniGuide, Aspect Medical, Covidien, Synthes and Aksys.

“I have worked for very small companies; I’ve also worked for billion-dollar organizations,” Avila told ConvergenceRI over coffee at Olga’s Cup + Saucer. “I much more enjoy the environment in the creation of a company, the hiring of talented people, the consolidation [of focus] into a single vision and direction. I’m excited; there is tremendous, tremendous potential [at IlluminOss].”

Here then, is the interview by ConvergenceRI with Manny Avila, the new president and CEO at IlluminOss Medical, in his first published interview since taking the position a few weeks ago.

ConvergenceRI: You’re from Rhode Island, is that correct? Tell me about your background.
AVILA:
Yes, I’m originally from Rhode Island. I grew up here; I went to high school in Providence at La Salle Academy. I went to college at the University of Rhode Island.

When I graduated, I moved up to Boston. I have been in medical devices my whole career.

I’m fortunate to have worked in a number of start-up environments.

I have worked for a home dialysis company in Chicago, an anesthesia monitoring company in Boston, and a surgical cutting tool firm in Boston.

ConvergenceRI: What excites you about the product and the opportunity?
AVILA:
I have some experience in the orthopedic industry. What intrigued me was the innovation that the product brings to the industry.

For the past 100 years, in the orthopedic industry, the metal plate has been the standard of care for patients. The evolution of that technology has been very gradual; the evolution has been centered on the materials for the plates, and the contour of the plate for the best fit to the patient’s anatomy.

[What IlluminOss has developed] is a step up in function, improving what is being done today.

We have a technology that is customized to the patient, that is really minimally invasive.

[Currently,] when you have fracture today, what they do [to fix it], they induce more trauma to the patient, they actually go in and dissect the soft tissue, you have to expose the fracture, then repair the fracture, and then they have to close it back up.

They are applying screws or other materials into healthy bone.

The new technology at IlluminOss doesn’t do any of that.

I’m sure you’ve seen the product. We have a deflated catheter balloon that is inserted into a very small opening of the bone, and it gets inflated to its end point within the canal of the bone. So it’s revolutionary.

The orthopedic industry needs [this new technology]; I think that they haven’t had enough innovation.

Obviously, surgeons and surgical applications are trying to find the optimum ways to treat the patient and minimize the trauma, minimize the amount of time the patient is spending in the hospital, and minimize the amount of time that patients need to recover and to heal.

And, we offer all that.

ConvergenceRI: How does the IlluminOss technology contrast, say, with robotics? Is it more responsive to the human anatomy?
AVILA:
I wouldn’t say that robotics have taken the human out of the equation at all. I think what robotics do is that they allow for more consistency in how patients are treated.

At my last company, we had a pretty close working relationship with Da Vinci, with robotics and surgery, so I was able to get a first-hand view.

In my experience, it appears to help surgeons who may not be the most comfortable with laparoscopic surgery.

The advantage of robotics, to me, is consistency. It allowed surgeons who had “OK” laparoscopic skills to really operate in a minimally invasive way, to be very consistent.

ConvergenceRI: What is the latest news about the ongoing clinical trials in the U.S.?
AVILA:
Our clinical trial in the U.S. is for fractures related to metastatic cancer. We have two trials going on in Europe, and one is very similar to that. The second is for a regular fracture of the humerus [bone] in the arm.

In the U.S., it’s a little more lengthy process to get approval. For our trial in the U.S., even though we have similar protocols in the U.S. that we have in Europe, we have almost double the number of people who are seeking to enroll in our trial.

We have in the mid- to high 20s in our current clinical trial in the U.S.

We’ve gotten a lot of really good results. Surgeons are raving about our technology.

The feedback from surgeons has been extremely positive; they can’t wait to use it for other bones in the body.

When they see the innovation [of the IlluminOss system], and they see how easy it is to provide, and they see how the length of time for the surgery is very short, they are very intrigued about the potential of this technology in their day-to-day practice.

ConvergenceRI: In terms of growth in the market, what is the target moving forward? Is it in sports medicine?
AVILA:
Sports medicine, I think, is an area that we’d like to pursue down the road.

When people envision [orthopedic] trauma, they often think about car accidents or skiing accidents, but the majority of trauma occurs in patients over the age of 50. A major contributing factor is osteoporosis, the fact that your bones begin to deteriorate once you’re over 30 years old.

When you look at the population [demographics], most fractures occur within an older, aging population. We want to focus on the age group where the majority [of fractures] are occurring.

ConvergenceRI: The “Baby Boom” generation and those older?
AVILA:
Exactly. Today, about 11 percent of the patient population is above 65 years or age. By 2050, that population doubles, to 22 percent, to those who will be above the age of 65.

If you were to [measure] out fractures by age group, there’s typically a spike up in the teen-ager years, resulting from skateboarding and bike riding [accidents].

It tapers off until the age of 50, and then it begins to grow. When you reach the age of 60-65, it really begins to escalate, from osteoporosis, from low trauma as a result of falling and breaking bones.

ConvergenceRI: Will Illuminoss’ new technology be easily coded and reimbursed by Medicare?
AVILA:
Yes. I do not see reimbursement as being a challenge.

The way that reimbursement works today, reimbursement is done by the procedure. We are actually evaluating what the reimbursement profile is for [our] procedure. We are comfortable that our technology fits with existing codes and reimbursements.

ConvergenceRI: The world of reimbursement, driven in large part by Medicaid and Medicare, is changing from fee-for-service to bundled payments across a continuum of care. The advantages that your innovative technology provides – quicker healing, less trauma, higher patient satisfaction, less time spent in a hospital – would appear to fit very well into the new model. What about any cost differentials?
AVILA:
When you bring new technology to market, typically, there is an expected premium that you’re paying for the technology, above and beyond the standard, and for us, I think, it will be because of the patient benefits we offer.

While we haven’t determined what our go-to-market price will be, I think we will be competitive with what’s currently out there, especially in terms of what we’ll offer from a clinical patient benefits perspective, and the cost of the product.

And, to the point that you made about bundled care, there’s a lot of great new technology that shortens the time that patients are in the hospital and the total cost of taking care of that patient.

Unfortunately, the way things are reimbursed today, everything is in its own small little pocket. It’s tough for a hospital administrator to look at that and say: we’re going to spend slightly more on the operating room procedure, but I’m going to have less patient cost because they’re not going to come back in as frequently, and re-infections will be cut.

Hospitals and insurance companies are going to gravitate toward technologies that are really going to make that can lower the overall cost of patient care and make the patient experience phenomenal.

They’re really going to be [willing to] spend more reimbursing technology that lowers the total cost of care for that patient.

That’s an evolution that we’re just beginning to see the start of.

ConvergenceRI: What’s it like to come back to Rhode Island? Does IlluminOss plan to stay here?
AVILA:
The facilities that we’re in today, we have plenty of room to stay and grow. We see ourselves staying here for a very, very, very long time.

We have the ability to begin our commercialization efforts in the U.S. and expand our presence in Europe.

From a location perspective, 40 miles up the road, we have a tremendous health tech environment. I think it’s close enough, as we grown and expand, to [attract] the higher skilled, talented people [we need].

The region in our backyard adds tremendous skills and experience.

ConvergenceRI: What’s your strategy moving forward?
AVILA:
We have a very clearly defined clinical strategy. We are well on our way to get all the applications that we believe we can support in Europe.

And we plan to leverage the data from Europe; we’ve done well over a thousand patients in Europe. We have a lot of data coming out of those clinical trials; we would like to leverage that data in the U.S.

ConvergenceRI: Can you explain how you will leverage that data?
AVILA:
We want to roll out the clinical results, utilizing it so that the FDA can feel comfortable, that we can show the demonstrated success in our trials in Europe and leverage that to help get approval here.

We hope to commercialize in the U.S. in 2017, so we are about 12 months from launching and selling a product in the U.S.

ConvergenceRI: What is the potential market for IlluminOss’s technology?
AVILA:
The market for internal fixation is about $5 billion, globally. The market in the U.S. is about $3 billion; every year, some $3 billion is spent on treating internal fractures. This is the market we’re competing in.

With the current product platform we have, and [the patients] we feel can treat today, of that $3 billion market in the U.S., we feel that that $1.4 billion of that market is available to us, once we start getting FDA approval. That’s a very nice market share, absolutely.

And, we have a product platform that provides much better patient outcomes, absolutely. It also allows us to be disruptive to the orthopedic supply chain.

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