AgNovos Healthcare has announced that its newest investigational product, AGN1 Local Osteo-enhancement Procedure (LOEP) Small Volume (SV) Kit, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).
If cleared by the FDA, the AGN1 LOEP SV kit would represent a breakthrough treatment for stable vertebral compression fractures, AgNovos said in a press release. The kit contains a proprietary, calcium-based, resorbable, tri-phasic implant material that is formulated to couple the pace of resorption to bone formation so that treated vertebrae are immediately, substantially and durably protected. A surgical kit containing the material is already approved in Europe for larger volume applications.
The FDA Breakthrough Devices Program is intended to expedite the development and review of devices that are either novel or have the potential to benefit patients with life-threatening or debilitating conditions. By accelerating the process of development and review, it is hoped that clinicians and patients will have faster access to devices that can improve the quality of care.
“Our receipt of the Breakthrough Device Designation is a welcome milestone in realising our mission of saving lives and protecting the quality of life of patients,” said Tanner Howe, president and CEO of AgNovos Healthcare. “We appreciate the collaboration from FDA as we identified and addressed the key questions required to secure this designation. We look forward to further collaboration as we work with FDA to finalise our clinical program to gather data to support an application for clearance in the USA. We believe that the device would give clinicians a powerful new tool to treat stable vertebral compression fractures in a more biologically-congruent fashion than they are treated today.”
Spine fractures afflict more than a half a million patients in the USA every year. These fractures often cause debilitating pain and can lead to a downward spiral of reduced mobility, independence and a greater likelihood of additional fractures. Other surgical approaches to address painful fractures in the spine exist but can have downsides, including the potential for some treatments to increase fracture risk in adjacent vertebral bodies, AgNovos said in its press release.