SUNNYVALE, Calif., Sept. 17, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, announced today that an abstract for preliminary data from the Company’s 1-level Investigational Device Exemption (IDE) clinical trial has been selected as an Innovative Technology Presentation during the 2018 North American Spine Society (NASS) Annual Meeting, being held September 26-29 in Los Angeles, Calif. Richard Guyer, M.D., Co-Principal Investigator for the study, will present the data at the session, and it will also be featured in a poster presentation.
David Hovda, CEO of Simplify Medical, commented, “We look forward to sharing initial results from a key site of our multi-center, prospective pivotal U.S. trial evaluating the Simplify Disc at one-level, for which we completed enrollment in February of this year. Our PEEK on ceramic Simplify Disc is engineered for durability, enhanced imaging with MRI, and with lower height options to better match patient anatomies. We are encouraged by our early data. If FDA-approved, we believe the Simplify Disc will offer patients and physicians in the U.S. a meaningful alternative to cervical fusion surgery and other currently available discs.”
Details of the oral presentation follow:
Simplify Medical: Clinical Outcomes of the PEEK-on-Ceramic Simplify Disc: Preliminary Data from One Site Participating in the Single-Level Cervical FDA IDE Trial
| Session: | Innovative Technology Presentations | |
| Date, Time: | Wednesday, September 26, 1:21-1:28pm | |
| Location: | Room 404AB | |
| Presenting Author: | Richard D. Guyer, MD, and Donna D. Ohnmeiss, PhD. | |
| Institutions: | Texas Back Institute and Texas Back Institute Research Foundation, | |
| Plano, Texas |
In addition, during NASS, the Simplify Cervical Artificial Disc will be awarded as a winner in the 10th Annual 2018 Spine Technology Awards, presented by RRY Publications and Orthopedics This Week. The Spine Technology Awards recognize the best new spine technologies, engineering teams and inventors for 2018 and, in the process, reward excellence in innovation.
To learn more about the Simplify Disc at one and two-levels, please visit Simplify Medical at Booth # 1911 in the Exhibit Hall.
About Simplify Disc
Simplify Disc is a motion preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and better match patients’ anatomies and kinematics. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize 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. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. 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. To learn more, visit http://www.simplifymedical.com/.
Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.
Simplify Medical Contacts:
Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com
Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com
