AgNovos Healthcare spine device achieves FDA breakthrough designation

Written by Alan Condon | March 26, 2020 | Print  |

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.

More articles on devices:
6 industry layoffs, furloughs for physician leaders to know
Dr. Neal ElAttrache defends orthopedic surgeries performed during COVID-19 crisis
'The patients are deferred; they're not going away,' says Life Spine CEO on coronavirus

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