21 Jun MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA
- CERAMENT G is the first combination product which has successfully navigated the DeNovo process.
- To date, MCRA has supported 5 of the 9 orthopedic DeNovos granted by the U.S.FDA, including the first 3 orthopedic and spine DeNovos.
WASHINGTON, June 16, 2022 /PRNewswire/ — 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.
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.
About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and served nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices and medical device cybersecurity. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specializes in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
About BONESUPPORT AB: BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The company is based in Lund, Sweden. www.bonesupport.com
For more information, please contact:
Elizabeth Baldacchino
Director, Business Development
Phone: 202.552.5811
Email: ebaldacchino@mcra.com