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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LOEP recommended as treatment option for patients at very high risk of hip fragility fractures

A recent position paper by a working group organized by the International Osteoporosis Foundation (IOF) and the European Society on the Clinical and Economic Aspects of Osteoporosis (ESCEO) defined the risk threshold for patients to be considered for available systemic and local treatments, including a Local Osteo-Enhancement Procedure (LOEP). The risk threshold varies by age and gender and can be determined using the FRAX risk assessment tool. The risk level of the potential treatment group for LOEP is the same as that being suggested for anabolic therapy. You can read more about the treatment selection algorithm here

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AGN1 LOEP proof-of-concept clinical study published in Osteoporosis International

This proof-of-concept clinical study was conducted at Copley Hospital in Morrisville, Vermont (U.S.) and followed 12 women with postmenopausal osteoporosis of the hip for up to seven years following treatment of one hip with AGN1 LOEP.  

 

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