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MCRA announced its role in the granting of De Novo classification by 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. Its dual mode of action is designed to deliver proven bone remodeling with reliable and safe local elution of gentamicin to protect bone healing.
BONESUPPORT’s CERAMENT G is reportedly the first antibiotic-eluting bone void filler to gain FDA approval. The De Novo 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, CEO, 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.”
To date, MCRA’s clinical and regulatory teams have supported five of the nine orthopedic De Novos granted by FDA, including the first three orthopedic and spine De Novos.
