MCRA, a privately held independent Clinical Research Organization (CRO) and healthcare advisory firm announced its key role in assisting Orthobond with obtaining a granted US Food and Drug Administration (FDA) De Novo for the Mariner Pedicle Screw System featuring Ostaguard™ coating. 

This achievement marks the first spine device treated with a coating designed to reduce bacterial contamination in the operating room.

The collaboration between Orthobond and MCRA dates back to March 2020 when Orthobond engaged MCRA to support their pre-submission efforts aimed at gaining FDA feedback on their proposed performance testing suite for Ostaguard antibacterial technology. 

MCRA's Spine team meticulously developed a regulatory strategy and provided comprehensive support throughout the FDA process, culminating in the successful submission of the De Novo application on Orthobond's behalf. The FDA granted approval for the Ostaguard antibacterial coating on the SeaSpine Mariner Pedicle Screw System for commercial use.

Justin Eggleton, Vice President and Head of Musculoskeletal Regulatory Affairs at MCRA, expressed his enthusiasm, stating, "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 underscores 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, aligning with our fundamental mission to facilitate the introduction of safe and effective medical innovations into our healthcare system."

David Nichols, CEO of Orthobond, commended MCRA's expertise and dedication, emphasizing their role in navigating the complex regulatory landscape. He stated, "Having worked with MCRA on other first-to-market technologies, I knew they would be the right partner for Orthobond when we began the De Novo 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 also 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."