Policy & Regulation
AgNovos Healthcare Receives Breakthrough Designation for Spine Device
26 March 2020 - - US-based medical technology developer AgNovos Healthcare's newest investigational product, AGN1 Local Osteo-enhancement Procedure Small Volume Kit, has been granted Breakthrough Device Designation by the US Food and Drug Administration, the company said.

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.

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 US 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.

Given the aging population in the US and globally, this problem is expected to become more common over time.

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.

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.

AgNovos Healthcare is a medical technology company specializing in minimally-invasive surgical procedures to address the local effects of bone disease.

The company's first product, the OSSURE Local Osteo-enhancement Procedure kit is CE-marked to treat local bone loss. The company is privately-held and headquartered in New York City, with manufacturing, research and development and corporate support services located in Rockville, Maryland. 
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