Simplify Medical looked at how we could improve upon existing devices to provide patients and surgeons the best cervical disc replacement available. Our lower disc heights, MRI imaging capabilities, physiologic motion, biologic materials, and straightforward procedure set us apart from other discs on the market.
Mr. Hovda has over 25 years of experience in the medical device industry. Prior to Simplify Medical and SpinalMotion, Simplify Medical’s predecessor company, he served as Vice President and Managing Director of the Spine and ENT divisions of ArthroCare, where he was responsible for the commercialization of numerous products and two business units. He also worked at Medtronic in corporate development and the corporate ventures group, which created the Inspire® sleep apnea treatment system. Mr. Hovda is a member of the Board of Directors for Pro-Dex, Inc. (PDEX, Nasdaq), a manufacturer of powered surgical instrumentation, where he is the Chairman of the Audit Committee. Mr. Hovda served as a Lieutenant in the United States Navy and completed two tours of duty. He received an MBA from Harvard Graduate School of Business Administration and a BS in Civil Engineering from Northwestern University. He is an inventor on over fifty medical device patents.
Ms. Lynch has been providing strategic legal and intellectual property advice to startup medical device companies for over 15 years. Prior to joining Simplify Medical, she served as Vice President, Intellectual Property at Conor Medsystems, Moximed, SpinalMotion, and Elixir Medical. Ms. Lynch was also a partner at one of the oldest and largest patent law firms in the U.S. and a Patent Examiner at the U.S. Patent and Trademark Office. She received her JD from George Mason University, her MBA from San Francisco State University, and a BS in Mechanical Engineering from Tufts University.
Ms. Neil has over 20 years of experience in the medical device industry, specializing in clinical research. Prior to joining Simplify Medical as the Vice President 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 MS degree in Physical Therapy from Duke University.
Dr. Alvis has over 20 years of experience in the preclinical assessment of medical devices and pharmaceutical agents. Prior to joining Simplify Medical, he served as General Manager of Angiotech Biomaterials, where he was responsible for all business activities at their Palo Alto, CA facility. He also worked at NeuColl Inc. in the capacity of Vice President of Research and Development. Dr. Alvis holds a Doctor of Veterinary Medicine degree from Colorado State University.
Mr. Polonet has worked in the medical device industry for 29 years, with the last 19 years in spine. Prior to joining Simplify Medical, he was a managing partner in TDR Associates, a consulting company which managed the one and two-level study enrollment for Simplify Medical. He has also held positions of Vice President of Sales and Marketing at Paradigm Surgical, LLC and Vice President of Sales at SpinalMotion. He has had a leadership role in four IDE studies for artificial discs. Mr. Polonet holds a BA in Business Administration from Austin College.
Ms. Norton has worked in the fields of reimbursement, outcomes research, and government relations for over 25 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. 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.
Mr. Barr has over 30 years of experience in quality assurance, operations, and research and development. Prior to joining Simplify Medical, he served in a variety of management positions for ArthroCare, Parallax Medical, and Norian. Mr. Barr also served as a materials scientist for Parallax Medical and Norian. He holds 17 patents and received his MS in Materials Science and Engineering from UCLA.
Dr. Arramon has over 20 years of experience designing spinal implants, vertebral compression fracture systems, and minimally invasive devices. He is a published author in the field of bone mechanics and bone remodeling. Prior to joining Simplify Medical, he served as Director, R&D Spinal Motion, Director of Product Development at Calcitec, Senior R&D Engineer at ArthroCare, and R&D engineer at Parallax Medical. Dr. Arramon holds a PhD in Mechanical Engineering from the City University of New York and has 20 issued U.S. patents in his name.
M.H. Carnegie & Co. is a venture capital, private equity, and alternative asset manager based in Sydney, Australia. Its funds manage direct investments on behalf of institutions, and wholesale and high net worth investors, with $350 million in committed capital across several funds.
LSP is one of Europe’s largest and most experienced healthcare investment firms with over 25 years of nurturing and growing healthcare investment opportunities with the potential to have a positive impact on society. LSP has offices in Amsterdam, Munich, and Boston.
Sectoral Asset Management is a healthcare specialist managing public and private equity portfolios. Sectoral has one of the world’s longest track records in managing biotech equities and is a sub-advisor of numerous healthcare and biotech funds offered by partners in Europe, North America, and Asia.
Simplify Medical is an independent company whose Simplify Cervical Artificial Disc, is currently FDA-approved for 1-level use. The late stage 2-level indication is not yet approved and is for investigational use only. Please stay tuned for updates. We’d love to hear from you.
Title: Simplify Medical Company Presentation
When: 11:00 AM Eastern Time
Who: David Hovda, Simplify Medical President & CEO
When: 5:00 PM Pacific Time
Who: Scott Blumenthal, MD, Orthopedic Spine Surgeon
When: 11:30 AM - 1:30 PM Eastern Time
Who: David Hovda, Simplify Medical President & CEO, and Brian Polonet, VP of Simplify Medical Sales & Marketing
Builds on recent 1-Level PMA Approval
SUNNYVALE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Simplify Medical, Inc., maker of the Simplify® Cervical Artificial Disc, announced today the completion of the Pre-Market Approval (PMA) submission for the 2-level Simplify Disc IDE Study to the U.S. Food and Drug Administration (FDA). The Simplify Disc is designed for MRI compatibility, physiologic ...
162. 2-level Cervical Disc Replacement Using a PEEK-on-Ceramic Device: Prospective Outcome Data from an FDA IDE Trial
Domagoj Coric, MD1; Richard D. Guyer, MD2; Pierce D. Nunley, MD3; K. Brandon Strenge, MD4; Donna D. Ohnmeiss, PhD5
1Carolina Neurosurgery & Spine Associates, Charlotte, NC, US; 2Center for Disc Replacement at Texas Back Institute, Plano, TX, US; 3Spine Institute of ...
161. Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Prospective Data from Seven Sites Participating in an FDA IDE Trial for Single-level Surgery
Richard D. Guyer, MD1; Domagoj Coric, MD2; Cameron N. Carmody, MD3; Rick C. Sasso, MD4; Michael J. Musacchio, MD5; Hyun W. Bae, MD6; Donna D. Ohnmeiss, PhD7
1Center for Disc Replacement at Texas Back Institute, Plano, TX, US; 2Carolina ...