The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to AgNovos Healthcare’s latest investigational product, the AGN1 Local Osteo-enhancement Procedure (LOEP) Small Volume (SV) kit.
This kit is an investigational device for treating stable but painful vertebral compression fractures through a less-invasive procedure. It was formally granted a breakthrough device designation from the FDA.
The IDE for the AGN1 LOEP SV kit will allow a study to be started to analyse the device’s ability to lower pain and support mobility in vertebral compression fracture patients.
AgNovos Healthcare president and CEO Tanner Howe said: “We are pleased that FDA has approved the IDE for the STAND study. We believe that the AGN1 LOEP SV kit has the potential to transform the treatment landscape for vertebral compression fractures.
“It is designed to work differently than traditional vertebral augmentation because the AGN1 implant material is intended to be resorbed and replaced by new bone.”
The AGN1 LOEP SV kit has all instruments and components needed to prepare the fractured vertebral body for injection with a resorbable, osteoconductive, tri-phasic implant material called AGN1.
Although the AGN1 LOEP SV kit is not approved yet, the AGN1 implant material is available in a CE-marked kit for forming new bone in the pelvis and other extremities.
According to data from preclinical and clinical studies, the device was shown to facilitate new bone formation and a quick, extensive and durable rise in the strength of osteoporotic femurs.
AgNovos Healthcare R&D and Global Regulatory Affairs senior vice-president Stephanie Kladakis said: “This approval allows us to advance our clinical research programme and continue to evaluate the treatment’s safety and efficacy in the STAND study.
“Our team has spoken with numerous clinicians in the US and Europe who are looking for alternative approaches to traditional vertebral augmentation to treat patients with certain vertebral compression fractures.”