Data Validates New Class of Devices for Intramedullary Biologic Fixation of Fractured Long Bones

Lexington, Mass.-based CBSET Inc., a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, has published efficacy data showing that percutaneous intramedullary fixation can provide for stabilization of bone fractures while avoiding the need for large tissue-dissections. Results of this study have been published in the Journal of Biomedical Materials Research Part B: Applied Biomaterials. The data validates, in preclinical models, a new class of orthopedic implants for intramedullary biologic fixation of fractured long bones.

The study focused on the IlluminOss system from East Providence, R.I.-based IlluminOss Medical Inc. The system is a percutaneous, patient-specific, fracture-stabilization system. This minimally invasive procedure incorporates the use of a thin-walled PET balloon, which is infused with a liquid monomer, inserted into the intramedullary canal conforming to the shape of the patient’s specific anatomy. The device forms as an implant once the surgeon activates the visible light within the PET balloon. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant. The IlluminOss System is CE-marked for light to low load-bearing bones.

“Our study validates the intramedullary application of a light-curable photodynamic bone stabilization system from study sponsor IlluminOss Medical as a biocompatible and feasible method for fracture fixation repair in load-bearing bones, such as the long bones of the leg,” said principal investigator Brett G. Zani, Ph.D., director of applied sciences, CBSET. “The data demonstrated that the photodynamic bone stabilization system did not disrupt bone formation when injected into intact bones, but did lead to increasing levels of cortical bone from 8 to 26 weeks when used in the fracture gap.”

The technology combines the use of proven medical polymers and traditional balloon catheter technology to provide a completely new technology for patient-specific, percutaneous orthopedic implants. Now, surgeons have the option to use the IlluminOss product alone or in conjunction with traditional hardware and screws for multiple types of fractures. The IlluminOss system is commercially available in international markets under a CE mark for approved clinical applications through both a direct sales force and distribution networks.

“CBSET’s preclinical expertise is widely respected and its validation of our bone stabilization system brings us another step closer to having our technology recognized for its potential to be a truly disruptive alternative to fracture repair,” said Robert Rabiner, president and founder of IlluminOss Medical. “We have been very pleased with the results that surgeons internationally have achieved using the IlluminOss System and now, as we begin treating patients as part of first U.S. clinical trial, we expect to see similarly positive benefits for patient outcomes. The efficacy data that CBSET has published supports the effectiveness of our approach.”

“IlluminOss represents a significant innovation in orthopedic trauma, providing patients with fracture fixation options that are metal-free and delivered in a minimally-invasive manner,” said Peter Markham, president, CEO and a co-founder of CBSET. “We are proud to have helped IlluminOss validate its novel technology. Since 2006, we have set the medtech gold standard for cutting-edge preclinical science, helping more than 400 companies transform their early-stage concepts into innovative therapies.”