Alexis is a regulatory affairs professional with over 30 years of experience in the start-up medical device company environment. She has a proven ability to drive the regulatory process, both as a direct employee and as a consultant. Her experience includes cardiovascular and gynecological device regulatory approvals, helping to grow companies from early start-up to viable companies. She developed and implemented regulatory and clinical strategies for multiple successful device approvals, three of which were novel first-of-a-kind devices. Past clients include Evalve, Inc. (acquired by Abbott Vascular), Asthmatx (acquired by Boston Scientific), Cierra, Inc and numerous other start-up device companies. Prior to working as a consultant, Alexis worked at the Foundry, LLC as Vice President of Clinical Research and Regulatory Affairs. Before that, she held positions including Vice President, Clinical Research and Regulatory Affairs at EMBOL-X, Inc. (acquired by Edwards Lifesciences), Director of Clinical Research and Regulatory Affairs at Conceptus, Inc. (public and later acquired by Bayer AG) where she was a Charter Member of the company, and various Clinical Research and Regulatory Affairs positions with increasing responsibility at Target Therapeutics, Inc. (a public company, acquired by Boston Scientific and later by Stryker). Alexis holds a Bachelors degree in Organizational Psychology from the University of California, Santa Barbara.
Important Safety Information:
The Mara Water Vapor Ablation System is indicated to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. Pregnancy following the Mara procedure can be dangerous. The Mara procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. As with all surgical procedures, there are risks and considerations associated with the use of the Mara Water Vapor Ablation System. Please refer to the device labeling for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.