IlluminOss Presents Novel Approach to Fracture Fixation

With recent expansion in European countries and a plan for a clinical trial in the U.S., IlluminOss Medical is beginning to develop clinical and economic data showing the benefits of its patient-customized fracture implant, the Photodynamic Bone Stabilization System (PBSS).

Implanted in about 400 patients to date, the PBSS is a deviation from traditional hardware used in fracture fixation technologies. A balloon is inserted into the bone canal, then a liquid monomer is inserted into the balloon and hardened with a light source to form an implant. The implant shapes to the bone canal and requires no direct bonding. Patients have near-immediate rotation stability.

BONEZONE spoke with Dirk Kuyper, Chief Executive Officer of IlluminOss Medical, about the fracture repair technology and the company’s plan to gain market share.

BONEZONE: Could you describe how the Photodynamic Bone Stabilization System works?

Dirk Kuyper: It’s a concept that takes a balloon similar to an angioplasty balloon made out of Dacron, which has been used in sutures and other medical products for 40 or so years, combines it with a liquid monomer that is similar to what has been used in dentistry for bonding teeth for about 50 years, and combines these to make a customized intramedullary implant for fractures or impending fractures.

The surgeon makes a small, (about 6.5 millimeter) incision to gain access into the bone, cleans out the canal, inserts the balloon across the fracture and fills it with the liquid. Then, it is hardened with a very specific visible light wave. What you get is a customized, immediately stable implant.

BONEZONE: What problem does this implant solve?

Kuyper: If you look at the implants that are popular today across fracture treatment, there’s casting, which debilitates a person for a long period of time and isn’t always successful. There’s plating, which really hasn’t evolved much. Then there are intramedullary nails, which have been around since the late '40s and early '50s, which haven’t changed a tremendous amount. None of those products were developed for patients with osteoporosis or metastatic bone disease. All of those products are designed for healthy bones that are easy to screw into, that are strong and that heal quickly. Our implant specifically addresses poor bone quality and provides a more minimally invasive and better fixation than you have when you’re dealing with bad bone quality.

BONEZONE: For what applications is this currently being used?

Kuyper: We have approval in Europe for low- to non-low bearing bones: the radius, ulna, fibula, distal radius—there are a number of bones for which we have a CE Mark. It’s being used extensively in wrist fractures, especially in elderly patients.


What’s amazing is that we’re seeing these patients go home in one day vs. four or five days if they had a volar plate, with one week of rehab instead of six. If an elderly person loses the use of her hand for five or six weeks, that has a pretty serious impact on her quality of life. The ability to get patients back using their hands almost immediately and to be self-sufficient is a huge improvement in terms of treatment. Our goal is to change the way surgeons and healthcare systems think about treating older patients with fractures, change the paradigm of treatment. The whole goal is get them back to their normal daily routine as quickly as possible. We do that substantially faster than traditional fixation methods.

BONEZONE: The cost of new and novel implants is a continual concern for healthcare systems in the U.S. and Europe. How are you addressing these concerns?

Kuyper: We’re doing an economic study on how much money the product saves. In the Netherlands, for instance, patients are going from about four or five days in the hospital to one day, six weeks of rehab down to one week; patients are regaining total mobility quickly. There is a significant cost savings both to the healthcare system and to the caregivers. We’re quantifying that, and will use that to justify the cost of our implant.

BONEZONE: What are your plans for product expansion?

Kuyper: In the short term, we’re not planning to expand much beyond where we are. The reasoning for that is we’re going to run two clinical trials, one in the U.S. and one in Europe, to get the rest of the bones, the weight bearing bones, femur, tibia and humerus approved for the indication, as well as develop the economic healthcare data I was talking about. Our plan over the next 18 months is to grow the user base, grow the clinical data, develop and publish economic data and then look to expand in 18 to 24 months.

BONEZONE: Based upon our knowledge of the market, this seems to be a novel technology. What competition do you have?

Kuyper: We’re extremely well-protected from an IP standpoint, so it would be difficult for somebody to come in and try to do what we’re doing. It’s really one of the first new fixations in fracture technology in the last 40 years. In terms of new competition, no, especially when we look at our potential target market segment of osteoporosis and metastatic bone disease. It’s such an improvement over the current treatment option that we really don’t see a lot of competition.

Dirk Kuyper has over 25 years of experience in commercializing medical devices. Prior to joining IlluminOss as CEO, Mr. Kuyper was President and CEO of Alphatec Spine,, where he led the company to triple revenue to $200 million and expanded the brand globally into 52 markets. Prior to Alphatec, as President of Aesculap, he successfully launched spinal and orthopaedic divisions. Questions may be sent to This email address is being protected from spambots. You need JavaScript enabled to view it..

IlluminOss
www.illuminoss.com