WASHINGTON, March 7, 2019 /PRNewswire/ — MCRA, LLC announced today its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve the Orthofix M6-C™ artificial cervical disc for the treatment of single level cervical disc degeneration. A next-generation artificial cervical disc, the M6-C disc developed by Spinal Kinetics LLC is the only artificial cervical disc designed to mimic the anatomic structure of a natural disc. To date, MCRA has assisted companies with 11 successful PMAs, including seven in the spine.
Spinal Kinetics, which was acquired by Orthofix Medical Inc. in 2018, initially retained MCRA in 2008 during the early stages of developing the clinical study strategy for the M6-C artificial cervical disc. The FDA approved the PMA for the M6-C disc on February 6, 2019, resulting in a 15-month review time between PMA submission and FDA approval. Additionally, the PMA approval for the M6-C artificial cervical disc is the first original PMA approval for a spinal device since 2015.
Tom Afzal, Founder and CEO of Spinal Kinetics and current General Manager of Motion Preservation at Orthofix, said, “We brought MCRA in early in our U.S. clinical trial process to evaluate our strategy and, thereafter, work with the team to support the PMA submission and ongoing FDA interactions. They provided tremendous support in analysis and presentation of data, input on responses, communications with the FDA, and overall messaging of safety and effectiveness of the M6-C artificial cervical disc. Their interactions with the FDA provided a high level of confidence for us and led to a timely PMA approval. They were an excellent partner and our collaboration with them couldn’t have gone better.”
Kevin B. McGowan, Director of Regulatory Affairs at MCRA, added, “We are extremely pleased to have worked with Spinal Kinetics in clinical study strategy and ultimately through the FDA’s rigorous PMA review process to enable the company to provide U.S. patients with another treatment option for cervical disc replacement. The MCRA regulatory team remains committed to helping companies bring new medical products to the U.S. market through our scientific and clinical knowledge coupled with our proven experience with the FDA approval process.”
About MCRA, LLC
Founded in 2004, MCRA is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach 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 nearly 500 clients globally. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.