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BioWorld - Monday, May 4, 2026
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Home » FDA OKs IDE trial of Agnovos Healthcare’s breakthrough spine device
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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.
Clinical Medical technology Regulatory Orthopedics U.S. FDA IDE

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