MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Cybersecurity is pleased to announce its role in the granting of the DeNovo by the U.S. Food and Drug Administration (FDA) for BONESUPPORT’S CERAMENT G, an implantable device/drug combination bone void filler that provides a one-stage approach for the management of bone infection with its unique dual mode of action that delivers proven bone remodeling with reliable and safe local elution of gentamicin to protect bone healing.
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BONESUPPORT’s CERAMENT G is the first antibiotic-eluting bone void filler to gain FDA approval. The DeNovo was supported by extensive laboratory testing, animal studies, and a robust clinical study of CERAMENT G which demonstrated a low recurrence of osteomyelitis and proven bone remodeling.
Emil Billback, Chief Executive Officer at BONESUPPORT said, “We’ve worked with MCRA since 2016. MCRA’s integrated service divisions have been very helpful and supportive in providing valuable strategic guidance and project support to BONESUPPORT since that time. I have been extremely happy with our decision to work with MCRA in support of our regulatory needs which is evidenced by this DeNovo achievement. We also appreciate the integrated role of the statistical experts from Biomedical Statistical Consulting in performing the analyses of our clinical data.”
Hollace Rhodes, MCRA’s Vice President of Orthopedic Regulatory Affairs, said, “We were pleased to work with BONESUPPORT’s team to bring this Breakthrough technology to the U.S. market. For the first time, patients in the U.S. will have access to CERAMENT G and its one-stage solution to osteomyelitis.”
MCRA is at the forefront of helping companies navigate the DeNovo regulatory pathway to achieve success in bringing novel devices to the U.S. market. To date, MCRA’s clinical and regulatory teams have supported 5 of the 9 orthopedic DeNovos granted by the U.S. FDA, including the first 3 orthopedic and spine DeNovos.