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.