AgNovos Healthcare, a developer of new therapies that leverage proprietary, bone-building technology and regenerative medicine to address unmet needs in the treatment of bone disease, announced the completion of enrollment for its CONFIRM study. CONFIRM is designed to generate additional data supporting the safety and efficacy of the Company’s AGN1 Local Osteo-Enhancement Procedure (LOEP) product when used in post-menopausal women with osteoporosis. With 60 subjects, CONFIRM is the fourth and largest study of LOEP to complete enrollment. This study includes women receiving unilateral or bilateral treatment with the CE-marked AGN1 LOEP kit.
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“The completion of patient enrollment in CONFIRM is an important development for the Company.” said Adam Lowe, Senior Vice President of Clinical Research and Quality at AgNovos Healthcare. He continued, “we look forward to completing the collection, analysis and publication of this data.”
Dr. Jo De Schepper is an orthopedic surgeon and principal investigator at the highest enrolling site, AZ Nikolaas in Sint Niklaas, Belgium. He commented, “the response to the study and technology has been very positive. I know my colleagues in orthopedics and metabolic bone health are interested to see this data. We know the impact that fragility fractures associated with osteoporotic bone loss have on our local communities and are encouraged by the promise of this therapeutic approach.”
CONFIRM patients are being enrolled in an extension study to evaluate LOEP’s impact during the five years following treatment.
The AGN1 LOEP Hip Kit contains the instruments and materials to perform a minimally invasive procedure to implant AGN1, a proprietary, calcium-based, osteoconductive, and tri-phasic implant material. AGN1 is uniquely formulated with a cell-friendly surface architecture and a resorption profile that enables the rapid formation of new bone. Preclinical and clinical research has shown that AGN1 LOEP treatment delivers immediate, substantial and durable increase in the strength of osteoporotic femurs. The kit is available in select markets under the brand name OSSURE® LOEP kit.
AgNovos Healthcare is a developer of new therapies that leverage proprietary, bone-building technology and regenerative medicine to address unmet needs in the treatment of bone disease. AgNovos Healthcare is privately held and has its corporate headquarters in New York City with manufacturing, research & development, and corporate support services located in Rockville, MD.