FDA Clears Bone Scaffold ReBOSSIS® for New Indication

Last month, the Food and Drug Administration cleared ReBOSSIS®, the only biosynthetic bone scaffold with electrospun microfiber construction, for use in posterolateral spine procedures.

“Having ReBOSSIS® used in these types of procedures reaffirms its place in today’s biologic market,” says Doris Blake, president and COO of ORTHOReBIRTH USA, a wholly owned subsidiary of ORTHOReBIRTH Co. Ltd., which produces ReBOSSIS®. “Surgeons have been impressed with the superior handling characteristics and the clinical results produced utilizing ReBOSSIS® as one of a number of treatment modalities that support successful outcomes for their patients.”

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In addition, tests performed at the Cleveland Clinic Lerner Research Institute and at the Orthopaedic Stem Cell Research Laboratory at Cedars-Sinai further validated the fact that ReBOSSIS® supports cell activation, retention, and proliferation. ReBOSSIS® also stands out from the competition with its demonstrated 54 percent compression recovery rate and optimal fit and fill—qualities that have led ReBOSSIS® to recently surpassing the 1,500-procedure milestone.

“We have been pleased with the outcomes seen with ReBOSSIS®,” says Blake, “and we are excited to witness its continued success in this new application.”

About ORTHOReBIRTH USA 

We recognize the challenges associated with orthopedic surgery—for patients, surgeons and hospitals alike. We are committed to bringing to market cutting-edge orthopedic biologics that improve patients’ quality of life and offer superior outcomes. We have carried out extensive studies on what makes biologic materials successful and have used that knowledge to engineer world-class products for use in a host of orthopedic surgical procedures. ORTHOReBIRTH USA is proud to bring premium orthopedic biologics, such as ReBOSSIS®, to surgeons practicing around the world.

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