FDA approves changes to Orthovita's Cortoss IDE pivotal study protocol

By Lisa Kerner

Erie, Pa., April 17 - Orthovita, Inc. said the Food and Drug Administration has approved further changes to the protocol for its Cortoss IDE (Investigational Device Exemption) pivotal study, including a reduction in the number of total patients to be enrolled to 243 from 300 and an increase in the randomization ratio of patients treated with Cortoss to patients in the control group.

The protocol now provides for the enrollment of 162 patients in the Cortoss arm of the study and 81 patients in the control group, for an overall randomization of 2:1, according to a company news release.

Orthovita said the prospective randomized controlled multi-center IDE study underway in the United States is designed to demonstrate that Cortoss is safe and effective for the treatment of osteoporotic vertebral compression fractures.

Patients in the study are being treated with Cortoss injected directly into the fractured vertebra (vertebroplasty).

"This latest development is expected to shorten the enrollment phase of the study and we believe the 2:1 randomization will provide further positive impetus to all who are involved in this clinical program," president and chief executive officer Antony Koblish said in the release.

Orthovita is a Malvern, Pa.-based biomaterials company that develops and commercializes synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications.

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