AgNovos Healthcare spine device achieves FDA breakthrough designation

Spinal Tech

The FDA awarded AgNovos Healthcare's AGN1 Local Osteo-enhancement Procedure small volume kit breakthrough device designation on March 26.

Three insights:

1. The AGN1 LOEP SV kit is an investigational device designed to treat stable vertebral compression fractures.

2. The kit features a tri-phasic implant material that is designed to couple the pace of resorption to bone formation so treated vertebrae are protected.

3. The tri-phasic implant material is approved in Europe to treat bone loss in higher volume applications at other anatomical sites.

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