Safety and Efficacy of New Class of Orthopedic Implant for Intramedullary Biologic Stabilization of Fractured Long Bones Studied Out to 1 Year

Safety and Efficacy of New Class of Orthopedic Implant for Intramedullary Biologic Stabilization of Fractured Long Bones Studied Out to 1 Year

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March 23, 2017

LEXINGTON, Mass.–(BUSINESS WIRE)–CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, announced today it has published safety and efficacy data at one year showing that percutaneous intramedullary fixation can provide for stabilization of bone fractures while avoiding the need for open surgery. Results of this study have been published in the Journal of Orthopaedic Research.

“Our study further evaluates the percutaneous application of the IlluminOss System, which is a light-curable photodynamic bone stabilization device developed by IlluminOss Medical as a safe and biocompatible treatment for fracture stabilization and repair in load-bearing bones, such as the long bones of the leg,” said co-investigator Brett G. Zani, Ph.D., Director of Applied Sciences, CBSET.

“Local biocompatibility evaluations comparing the IlluminOss System to standard K-wire implants showed no significant long-term local tissue reactions associated with either implant, and good systemic biocompatibility of the IlluminOss System over the course of a year,” added co-investigator and CBSET scientist Amanda L. McSweeney.

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. It combines the use of proven medical polymers and traditional balloon catheter technology to provide a completely new technology for patient-specific, percutaneous orthopedic implants. The implant begins as a liquid monomer that is completely contained within a Dacron or PET balloon. Once inside a patient’s bone, it conforms to the geometry of that patient’s intramedullary canal, whereas traditional rigid intramedullary rods have only small discrete contact points. Now, international surgeons have the option to use the IlluminOss product alone or in conjunction with traditional hardware and screws for multiple types of fractures.

“CBSET’s high-quality preclinical evaluation continues to substantiate the application of our bone stabilization system and its potential to be a truly disruptive alternative to traditional fracture repair,” said Robert Rabiner, Chief Technical Officer & Founder of IlluminOss Medical.

“CBSET strives to help innovative companies such as IlluminOss to develop new and disruptive technologies that foster paradigm-shifting improvements in patient care. In this case, for patients requiring fracture-fixation in an orthopedic trauma care unit, access to a new solution that is metal-free and can be performed in a minimally invasive manner, and not open surgery, is exciting, and our organization is proud to have contributed,” said Peter Markham, President, CEO and a co-founder of CBSET.

To learn more about these results and the services provided by CBSET, please contact: Michael Naimark, Director, Business Development: +1-970-988-5273, mnaimark@cbset.org.

* The IluminOss™ System is approved for sale in Europe and for investigational use in the U.S.

About CBSET
CBSET Inc. — 500 Shire Way, Lexington, Mass. — is the preclinical research leader in therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products. Learn more about CBSET’s expert biomedical research services.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

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