Orthovita, Inc. Announces Completion Of Patient Enrollment In Its U.S. Pivotal Clinical Study For The Use Of CORTOSS(R) In The Treatment Of Vertebral Compression Fractures

MALVERN, Pa.--(BUSINESS WIRE)--Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, reported that it has completed patient enrollment for its pivotal, prospective, randomized study for CORTOSS® Bone Augmentation Material in development for the treatment of vertebral compression fractures. The study is being conducted under an FDA Investigational Device Exemption (IDE) and is designed to assess the safety and efficacy of CORTOSS for the treatment of osteoporotic vertebral compression fractures as compared to commercially available polymethylmethacrylate (PMMA) bone cement. A total of 256 patients are enrolled in the pivotal study with a randomization of approximately 2:1 (162 patients treated using CORTOSS and 94 patients treated using a PMMA bone cement) at 22 sites.

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