Client Need
Companion Spine is a company dedicated to interventional back pain treatment. They retained MCRA for regulatory strategy and execution to overcome historical FDA regulatory challenges from prior study sponsor.
MCRA’s integrated teams helped Companion Spine achieve US FDA PMA Approval, and Breakthrough Device Designation for Companion Spine’s DIAM™ Spinal Stabilization System.
MCRA Approach
MCRA employed a highly strategic, integrated approach by executing a dedicated clinical study to collect long‑term follow‑up data on the original IDE cohort over more than 10 years—a novel methodology that ultimately proved pivotal to the program’s success. Across the project’s full lifecycle, MCRA provided comprehensive support including regulatory strategy development, Breakthrough Device submission, PMA preparation and FDA negotiations, biocompatibility planning, clinical study design and execution, and ongoing safety management.
MCRA THERAPY: Spine
MCRA SERVICES: US Regulatory, Clinical, Safety Management (CEC), Biocompatibility, and Quality Assurance
Outcome
MCRA’s team assisted in securing US FDA PMA Approval, and Breakthrough Device Designation, for Companion Spine’s DIAM™ Spinal Stabilization System. MCRA designed and executed a 10+ year long-term follow up study to achieve this.
"The DIAM™ Spinal Stabilization System PMA marks a defining milestone for Companion Spine. It reflects years of rigorous clinical follow‑up and close collaboration with MCRA, whose regulatory expertise and clinical team’s dedication to conducting the long‑term follow‑up study were instrumental in overcoming prior challenges and securing FDA approval. This achievement underscores our commitment to delivering safe, effective, and durable minimally invasive, motion‑preserving solutions for appropriately selected patients, supported by robust clinical evidence.”
“It has been a true pleasure to support the Companion Spine team in achieving PMA approval for DIAM—a device with an extensive and complex regulatory history. The regulatory challenges Companion Spine inherited when
acquiring DIAM required a thoughtful regulatory strategy, rigorous long‑term follow‑up data, and a commitment to working transparently and collaboratively with FDA. I’m incredibly proud of how the multi-disciplinary MCRA team partnered with Companion Spine, the study investigators, and FDA to fully understand and address every concern, ultimately enabling us to bring this important therapy to the U.S. market and to patients who have long awaited additional treatment options.”
"The DIAM Spinal Stabilization System study was a truly distinctive experience from a clinical execution perspective. By thinking creatively and exploring innovative approaches, the sponsor successfully collected and reported over 10 years of follow-up data on the majority of the patient population—significantly strengthening the narrative presented to the FDA. Achieving PMA approval was the culmination of a complete team effort, many years in the making.”
