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