Allegra Orthopaedics Limited provided the following update on its innovation project, the Sr-HT-Gahnite Spinal Cage Device (Spinal Cage): Allegra announced the large animal study performed at SAHMRI - PIRL (South Australian Health and Medical Research Institute - Preclinical, Imaging and Research Laboratories) has entered into its final stages with all animals implanted successfully. SAHMRI is conducting the GLP, pre-clinical, cervical spinal fusion study in sheep for the interbody fusion Sr-HT-Gahnite Spinal Cage Device. In addition to CT scans, histological analyses will be performed following the completion of the in-life phase to provide further evidence of successful spinal fusion.

The completion of this study and the positive results being realized will confirm a viable pathway to obtaining a 90 day FDA 510(k) clearance in the near future in the United States. Allegra Orthopaedics is the sole proprietor of the Sr-HT-Gahnite material and aims to apply the technology to fulfilling unmet needs across a broad range of applications including Spine, Hip & Knee and extremities.