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MCRA was selected by Simplify Medical to manage and execute the company’s clinical study and FDA premarket approval (PMA) of the Simplify cervical spinal disc replacement for one-level procedures. To date, MCRA’s clinical and regulatory teams have supported successful PMAs for eight spinal technologies.
The Simplify Disc is designed for MRI compatibility, physiologic motion and anatomical height-matching, to support improved patient outcomes.
MCRA is also assisting with the two-level trial and PMA development. Enrollment for the 2-level trial was completed in 2018, and discussions with FDA regarding the PMA are underway.
Abigail Allen, MCRA’s Vice President of Clinical Affairs, said, “Simplify brought us in on day one to establish a data management platform as well as help with the final design of the clinical study and to provide support with initiation of sites. This collaboration with Simplify Medical allowed us to create efficiencies and execute the study with precision, which allowed swift enrollment, high accountability, and ultimately a fast approval.”
David Hovda, President and CEO of Simplify Medical, said, “Simplify’s management is very pleased to have chosen MCRA for its highly specialized talent as well as its accessibility. I really appreciate MCRA’s support over the years. We are thankful to have established a great relationship with MCRA, which is a huge part of our success. I can’t say enough great things about the team and how they have guided us through our studies.”
