SUNNYVALE, Calif., June 12, 2018 (GLOBE NEWSWIRE) -- Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced that it has expanded its leadership team with the appointments of Brian Polonet as Vice President, Sales and Marketing and Kim Norton as Vice President, Reimbursement. Both appointments are effective immediately and together bring decades of executive experience in the medical device space to the Simplify Medical leadership team. In addition, two key members of the leadership team have been promoted: Beth Neil to Vice President, Clinical Affairs and Mark Alvis, DVM to Vice President, Quality Assurance & Operations.
Mr. Polonet will lead the Company’s sales and marketing initiatives to drive increased adoption in Europe and prepare for expected commercial launch in the U.S. following requisite regulatory approval. Ms. Norton will manage payer relations and oversee the development and execution of the Company’s reimbursement strategy as it continues to expand the number of covered lives for both one and two-level implantation.
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.
David Hovda, Chief Executive Officer of Simplify Medical, commented, “I am extremely pleased to announce the high caliber additions of Mr. Polonet and Ms. Norton to our team as we work diligently to expand our commercial and corporate presence and prepare to bring our innovative disc to the U.S. market following FDA PMA submission and approval. These appointments complement the progress we’ve made to date, especially in the enrollment for our one and two-level IDE clinical trials, and demonstrate our evolving focus as we build off our momentum and approach a critical juncture of growth.”
Mr. Polonet joins the Company with 25 years of experience in the medical device industry, with the last 17 years in Spine. Most recently he was a managing partner at TDR Associates, a consulting company which managed the one and two-level study enrollment for Simplify Medical. He previously held positions as Vice President of Sales and Marketing at Paradigm Surgical, LLC and prior to that, as Vice President of Sales at SpinalMotion. He has had a leadership role in four IDE studies for artificial discs. Mr. Polonet holds a Bachelor of Arts in Business Administration from Austin College.
Ms. Norton has worked in the fields of reimbursement, outcomes research, and government relations for over 20 years. She has deep experience with artificial disc technologies, having led the reimbursement efforts at several companies, including as Head of Reimbursement and Payer Relations for Aesculap, Inc., a medical device company focused on spine and orthopedic implants based in Allentown, Pennsylvania, and Vice President of Reimbursement for both LDR Spine and DePuy Synthes. Kim earned a master's degree in public policy from the University of California at Berkeley and a BA in political science from Wellesley College.
Ms. Neil has nearly 20 years of experience in the medical device industry, specializing 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. Ms. Neil holds an M.S. degree in Physical Therapy from Duke University.
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, CA 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.
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 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:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Kirsten Thomas, The Ruth Group