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.