NEW YORK–(BUSINESS WIRE)–AgNovos Healthcare, a developer of medical technology products to treat the local effects of bone disease, announced today that its newest investigational product, AGN1 Local Osteo-enhancement Procedure (LOEP) Small Volume (SV) 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.
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 realizing 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 finalize our clinical program to gather data to support an application for clearance in the U.S. 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.”
“I have spoken with numerous clinicians in the U.S. and Europe who are looking for alternative approaches to treating patients with stable but painful vertebral compression fractures,” explained Dr. James Howe, Chief Medical Officer of AgNovos Healthcare. “It is great that FDA has prioritized its review of our device and will consider making it available for clinicians in the U.S.”
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.
About the AGN1 LOEP Small Volume (SV) Kit
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.
About AgNovos Healthcare
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 & development and corporate support services located in Rockville, Maryland. www.agnovos.com
CAUTION this press release refers to an investigational device. The device is limited by United States law to investigational use only.
- Burge et al., Journal of Bone and Mineral Research, 22:3; 2007; doi: 10.1359/JBMR.061113
- Lindsay et al., Journal of the American Medical Association, 2001; doi: 10.1001/jama.285.3.320
- Takahara et al, BMC Musculoskeletal Disorders, 17:12; 2016; DOI 10.1186/s12891-016-0887-0
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