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The AGN1 LOEP SV Kit is an investigational medical device developed by AgNovos Healthcare for the treatment of stable but painful vertebral compression fractures (VCFs), typically associated with osteoporosis. The kit utilizes a proprietary, calcium-based, resorbable, tri-phasic implant material known as AGN1. During the procedure, the material is injected into the fractured vertebral body following saline lavage. Unlike traditional polymethylmethacrylate (PMMA) bone cement, which remains as a permanent foreign body, AGN1 is designed to be osteoconductive, allowing it to be gradually resorbed and replaced by the patient's natural bone. This biological approach aims to restore vertebral strength while potentially reducing the risk of subsequent fractures in adjacent vertebrae.
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