Simplify Medical Pty Ltd has a new eagle eye to ensure that things keep running smoothly. Mark Alvis, DVM, has been promoted to Vice President of Quality Assurance & Operations.
Mark Alvis, DVM: New VP at Simplify Medical
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According to the company, “Dr. Alvis has been part of Simplify Medical since 2007, serving as Director, Quality Assurance. Prior to joining Simplify Medical, Dr. Alvis served as General Manager of Angiotech Biomaterials, where he was responsible for all business activities at their Palo Alto, California facility. He also served as Vice President of Research and Development at NeuColl Inc. Dr. Alvis has 20 years of experience in the preclinical assessment of medical devices and pharmaceutical agents and holds a Doctor of Veterinary Medicine degree from Colorado State University.”
Mark Alvis told OTW, “I am excited for my promotion to VP Quality Assurance and Operations and the opportunity to lead our efforts towards submission of our non-clinical and manufacturing PMA [pre-market approval] modules in the upcoming months.”
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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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