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BioWorld - Thursday, December 25, 2025
Home » Keywords » AGN1 LOEP SV kit

Items Tagged with 'AGN1 LOEP SV kit'

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AGN1 LEOP SV kit image

FDA OKs IDE trial of Agnovos Healthcare’s breakthrough spine device

April 19, 2021
By Meg Bryant
Agnovos Healthcare LLC, a company using regenerative medicine to treat localized effects of bone disease, has received the FDA’s nod for an IDE clinical trial to assess its AGN1 local osteo-enhancement procedure (LOEP) small-volume (SV) kit in patients with vertebral compression fractures (VCFs). The investigational device is intended to treat stable but painful VCFs via a minimally invasive procedure. The kit, which comes in the form of two single-use trays, contains a calcium-based, resorbable, triphasic implant material that is designed to align the pace of resorption with bone formation, providing treated vertebrae with immediate and durable protection.
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