It’s corporate rearrangement time at Simplify Medical Pty Ltd. Beth Neil, a 20-year veteran of the medical device industry, has been promoted to Vice President of Clinical Affairs at the company, makers of the Simplify cervical artificial disc.
Beth Neil: New VP, Clinical Affairs at Simplify Medical
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Neil specializes in clinical research. “Prior to joining Simplify Medical as the Director of Clinical Affairs, she held positions with Link Spine Group and Healthtronics Surgical Services, as well as various contract research organizations. Neil holds an M.S. degree in physical therapy from Duke University.”
As indicated by Simplify Medical, “The appointments were made as the Company expands commercial efforts in Europe where it is CE marked and pursues the completion of one and two-level U.S. IDE clinical trials for the implantation of its cervical artificial disc between C3 to C7. The Company completed enrollment of its one-level trial in February 2018 with 166 patients enrolled at 16 U.S. sites and anticipates complete enrollment of 200 patients at 18 centers in its two-level study by the end of 2018.”
Beth Neil told OTW, “As VP of Clinical Affairs, I am looking forward to completing enrollment in the 2-level study and executing the submission of two PMAs [pre-market approvals]. This is an exciting time for us and I am so pleased to be part of the management team.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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