SUNNYVALE, Calif., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® Cervical Artificial Disc, announced today the North American Spine Society (NASS) selected two abstracts on the Simplify Disc for the Best Papers Section. The papers are being presented on both the 1-level and 2-level study outcomes by the co-primary investigators of the clinical trials- Richard Guyer, MD and Domagoj Coric, MD.
The Simplify Disc PMA for the 1-level indication was recently approved by the FDA, achieving the quickest approval for any spine PMA. Simplify Disc’s overall success rate of 93.0% was superior to the ACDF control at 73.6%. The late-stage 2-level indication is not yet approved and is for investigational use only.
North American Spine Society, NASS2020 Virtual Experience
| Date: | Friday, October 9, 2020 |
| Session: | Best Papers |
| Time: | 3:12-3:19pm Eastern Daylight Time (EDT) |
| Title: | 161. Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Prospective Data from Seven Sites Participating in an FDA IDE Trial for Single-level Surgery |
| Presenter: | Richard Guyer, MD - Chairman, Texas Back Institute Foundation |
| Date: | Friday, October 9, 2020 |
| Session: | Best Papers |
| Time: | 3:19-3:26pm Eastern Daylight Time (EDT) |
| Title: | 162. Two-level Cervical Disc Replacement Using a PEEK-on-Ceramic Device: Prospective Outcome Data from an FDA IDE Trial |
| Presenter: | Domagoj Coric, MD - Chief, Dept. of Neurosurgery at Carolinas Medical Center |
NASS 2020 Annual Meeting Virtual Experience Conference: https://www.spine.org/am
About Simplify® Disc
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 ionizing radiation. 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.
The Simplify Disc is CE Marked in Europe and commercially available in select European markets.
About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.
Company Contact:
Simplify Medical
Kelsey Welch
Director of Marketing
+1-951-836-1062
kwelch@simplifymedical.com
Investor Contact:
LifeSci Advisors, LLC
Bob Yedid
+1-646-597-6989
bob@lifesciadvisors.com