MCRA Responsible for Regulatory Strategy and Support for FDA Submission Process
WASHINGTON, May 7th, 2024/PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and healthcare advisory firm is proud to announce its role in supporting Orthobond with achieving a granted US Food and Drug Administration (FDA) De Novo for the Mariner Pedicle Screw System with OstaguardTM coating. This De Novo grant marks the first spine device to be treated with a coating that reduces bacterial contamination in the operating room.
Orthobond engaged MCRA in March 2020 to help support their pre-submission efforts in gaining FDA feedback to their proposed performance testing suite for their Ostaguard antibacterial technology. MCRA’s Spine team developed the regulatory strategy with subsequent pre-submission and supported Orthobond through the entirety of the FDA process and submitted the De Novo on Orthobond’s behalf. On April 5th, the FDA granted the Ostaguard antibacterial coating on the SeaSpine Mariner Pedicle Screw System for commercial use.
Justin Eggleton, Vice President, Head of Musculoskeletal Regulatory Affairs, states “This De Novo grant is a testament to Orthobond’s relentless innovation and marks a significant leap forward in patient care and safety. The FDA’s favorable decision demonstrates Orthobond’s vision and Ostaguard’s potential to make a major difference in healthcare. MCRA takes immense pride in supporting Orthobond’s important regulatory milestone, which resonates with our fundamental mission to facilitate the introduction of safe and effective medical innovations into our healthcare system.”
David Nichols, CEO of Orthobond, states “Having worked with MCRA on other first-to-market technologies, I knew they would be the right partner for Orthobond when we began the DeNovo process for our antibacterial surface technology, Ostaguard. MCRA possesses the breadth and depth of talent necessary to not only deal with the regulatory plans and overall strategy, but the critical daily tactics such as regulatory research, documentation and writing. What MCRA brings to a project like this is a diversely talented team focused on ensuring a submission of this magnitude is done with expertise.”
About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client's industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity, and distributions logistics 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, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. www.mcra.com
About Orthobond Corporation: Orthobond Corporation is a surface technology company that has developed proprietary antibacterial surfaces, with broad applications in the medical device industry and more such as commercial, industrial, automotive, and beyond. Orthobond is the first company to utilize surface modifications that can be permanently bound to any surface, killing bacteria by mechanically rupturing pathogens without using eluting antibiotics.
For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com