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AgNovos Healthcare, a New York-based developer of medical technology products to treat the local effects of bone disease with manufacturing, research and development and corporate support services in Rockville, announced Thursday its newest investigational product, AGN1 Local Osteo-enhancement Procedure Small Volume Kit, has been granted Breakthrough Device Designation by the U.S. 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. The kit contains a proprietary, calcium-based, resorbable, tri-phasic implant material that is uniquely 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.
AgNovos Healthcare’s investigational spine device received breakthrough device designation from the FDA.
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.
Spine fractures afflict more than a half a million patients in the U.S. every year. These fractures often cause debilitating pain and can lead to a downward spiral of reduced mobility, independence1 and a greater likelihood of additional fractures2. Given the aging population in the U.S. and globally, this problem is expected to become more common over time1. 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 bodies3.
The AGN1 LOEP SV Kit is an investigational device intended to minimally-invasively treat painful but stable vertebral compression fractures that are often caused by bone loss associated with osteoporosis. The kit contains all of the instruments and components necessary to prepare the fractured vertebral body for injection with the proprietary, calcium-based, osteoconductive, tri-phasic implant material. The implant material is already approved in Europe to treat bone loss in higher volume applications at other anatomical sites.
