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Orthobond, in Collaboration with MCRA, Receives De Novo Approval for Innovative Pedicle Screw System Utilizing Ostaguard™ Coating

Wednesday, May 08, 2024

MCRA, a leading privately held Clinical Research Organization (CRO) specializing in medical devices, diagnostics, and biologics, proudly announces its pivotal role in assisting Orthobond in securing a granted US Food and Drug Administration (FDA) De Novo for the Mariner Pedicle Screw System with Ostaguard™ coating.

This achievement marks a groundbreaking milestone as the first spine device to feature a coating specifically designed to mitigate bacterial contamination in surgical settings.

Orthobond enlisted MCRA's support in March 2020 to bolster their pre-submission endeavors aimed at obtaining FDA feedback on their proposed performance testing suite for the Ostaguard antibacterial technology.

Leveraging the expertise of MCRA's Spine team, a robust regulatory strategy was crafted, culminating in the successful submission and subsequent navigation of the FDA approval process on behalf of Orthobond. On April 5th, the FDA officially granted approval for the Ostaguard antibacterial coating on the SeaSpine Mariner Pedicle Screw System for commercial deployment.

Vice President and Head of Musculoskeletal Regulatory Affairs at MCRA, affirms, "This De Novo grant underscores Orthobond's unwavering commitment to innovation and signifies a significant advancement in patient safety and care.

The FDA's endorsement underscores Orthobond's vision and highlights the transformative potential of Ostaguard in healthcare. MCRA is honored to have played a pivotal role in supporting Orthobond's regulatory journey, aligning seamlessly with our core mission of facilitating the introduction of safe and efficacious medical advancements into the healthcare ecosystem."

Having previously collaborated with MCRA on pioneering technologies, I had full confidence in their capabilities when embarking on the De Novo process for our antibacterial surface technology, Ostaguard. MCRA's multidisciplinary expertise was instrumental not only in shaping regulatory plans and overarching strategy but also in executing crucial daily tasks such as regulatory research and documentation.

Their diverse talent pool ensured that a submission of this magnitude was executed with precision and expertise.





Source: prnewswire.com

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