MCRA has announced its role in the successful management and execution of Simplify Medical's clinical study and approval by the U.S. Food and Drug Administration (FDA) of their Premarket Approval (PMA) for the Simplify Disc.
"MCRA is honored to be part of this significant approval and would like to thank the Simplify senior management team, including Beth Neil, Vice President of Clinical Affairs and David Hovda, Chief Executive Officer. 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,” Abigail Allen, MCRA's Vice President of Clinical Affairs, said. “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."
The Simplify Disc is designed for MRI compatibility, physiologic motion, and anatomical height-matching, with the goal of improving patient outcomes and expanding treatment options for patients. The Simplify Disc is indicated for DDD for 1-level cervical implantation between C3-C7.
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"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," David Hovda, President and CEO of Simplify Medical, said.
In conjunction with the 1-level study, MCRA is also assisting with the 2-level trial and PMA development. The enrollment for the 2-level trial was completed in November 2018 and discussions with FDA regarding the PMA are underway.