AgNovos Healthcare Receives Breakthrough Designation for Spine Device

AgNovos Healthcare, a developer of medical technology products to treat the local effects of bone disease, announced today that its newest investigational product, AGN1 Local Osteo-enhancement Procedure (LOEP) Small Volume (SV) Kit, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). If cleared by the FDA, the AGN1 LOEP SV kit would represent a breakthrough treatment for stable vertebral compression fractures.

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Study showing treatment of osteoporotic vertebrae with LOEP enhances biomechanical properties is published in Archives of Orthopaedic and Trauma Surgery 2020

The study showed that treatment of intact osteoporotic vertebrae with a local osteo‑enhancement procedure (LOEP), using a proprietary, tri-phasic implant material, led to an increase in strength and no difference in stiffness.  

The manuscript was published in Archives of Orthopaedic and Trauma Surgery 2020. Click here to read the manuscript.


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