– MCRA’s CRO assisted Simplify Medical with the management of the clinical study, including leading data management, Clinical Events Committee (CEC), and monitoring support for the successful PMA approval.
– MCRA additionally integrated its world-class regulatory, reimbursement, and quality assurance services to support the management team of Simplify Medical in their successful PMA approval of their 1-level indication of the Simplify Disc.
– Simplify Medical’s PMA was the fastest spine PMA approval ever, 31% faster than the second-fastest spine PMA approval.
WASHINGTON, Oct. 1, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce its role in the successful management and execution of Simplify Medical, Inc.’s clinical study and approval by the U.S. Food and Drug Administration (FDA) of their Premarket Approval (PMA) for the Simplify Disc. To date, MCRA’s clinical and regulatory teams have supported 15 successful PMAs, including eight spinal technologies.
Abigail Allen, MCRA’s Vice President of Clinical Affairs, said, “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. 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.
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.”
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.
Justin Eggleton, MCRA’s Vice President of Spine Regulatory Affairs, said, “Simplify Medical’s PMA approval is anchored by a well-executed clinical study that required significant collaboration between MCRA and Simplify. The clinical study results demonstrate a notable benefit-risk profile that, when including the novel biomaterials and shorter device heights, address an unmet clinical need for this patient population. FDA provided valuable feedback during the course of the IDE study that was important to ensuring the PMA diligently presented all clinical data to demonstrate safety and effectiveness with a positive benefit-risk profile.”
About MCRA, LLC: MCRA is a leading medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA’s value contribution rests within its industry experience at integrating five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices.
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (V.B.), founded MCRA in 2004. V.B. is headquartered in New York City and specialized in venture capital, private equity, and merchant banking for the neuromusculoskeletal industry.