Simplify Medical Completes PMA Submission for 1-Level Simplify Disc IDE Study
FDA Determined PMA is Complete and is Commencing Filing Review
Sunnyvale, CA – April 21, 2020 – Simplify Medical Pty Ltd., maker of the Simplify® Cervical Artificial Disc, announced today the completion of the Pre-Market Approval (PMA) submission for the 1-level Simplify Disc IDE Study to the U.S. Food and Drug Administration (FDA). The Simplify Disc is designed for MRI compatibility, physiologic motion, and anatomical height-matching, with the goals of improving patient outcomes and expanding treatment options for patients.
David Hovda, President and CEO of Simplify Medical, said, "The submission of our 1-level PMA study is the culmination of hard work and years of data collection. I’d like to thank all of our dedicated surgeon investigators and their teams who have participated in the trial. We are very proud to have completed this pivotal milestone in the FDA approval process.”
The prospective, multi-center clinical trial enrolled a total of 166 patients at 16 clinical sites across the United States, with enrollment completed in February 2018. The Simplify Disc was used for 1-level cervical implantation between C3 to C7 vertebrae and compared with historical fusion control.
Richard Guyer, MD, chairman of the Texas Back Research Institute Foundation and national Co-Principal Investigator for the study commented, “We are excited for this important milestone in the FDA approval process. In addition to the strong clinical evidence produced in the Simplify Disc 1-level trial, this cervical disc offers the benefits of a replacement that is anatomic in design, mimics the motion of a normal healthy disc and allows for distortion free MR imaging. I believe this technological advancement is going to improve clinical outcomes for patients undergoing treatment for cervical disc disease.”
Domagoj Coric, MD, Chief of Neurosurgery at Carolinas Medical Center and national Co-Principal Investigator for the study stated, “I am excited about reaching this important milestone in the regulatory process for this next generation cervical artificial disc with unique biomaterials.”
The Simplify Disc is also being evaluated in a separate IDE trial in the U.S. for 2-level procedures. The enrollment for the 2-level trial was completed in November 2018. The Simplify Disc is CE Marked in Europe and commercially available in select European markets. Internationally, early market feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.
Simplify Disc is a motion-preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, to better match patients’ anatomies and for physiologic movement. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI, potentially minimizing patient exposure to radiation. The Simplify Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. The three-piece disc, with a semi-constrained mobile core is designed to mimic/replicate the natural biomechanical motion of a healthy disc. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.
About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California.