Sean Ianchulev, MD MPH
CEO, CMO & Director
Dr. Ianchulev has been serving as our Chief Executive Officer and Chief Medical Officer and a member of our Board of Directors since March 2014. From 2009 to 2016, he was the chief medical officer and the head of technology and business development for Transcend Medical, Inc. (acquired by Novartis International AG/Alcon, Inc. (NYSE: NVS)). Prior to that, while at Genentech, Inc. (NASDAQ: DNA, before going private in 2009), Dr. Ianchulev headed the ophthalmology research group and directed the development and the FDA approval of Lucentis. Dr. Ianchulev currently serves as a director of the ASCRS Foundation. He was formerly chairman of the board of directors of ianTech from 2014 until its acquisition by Carl Zeiss Meditec in 2019. Dr. Ianchulev received his B.S. from the University of Rochester. He received both his M.D. and an M.P.H. from Harvard University and completed his specialty training at the Doheny Eye Institute. Currently, Dr. Ianchulev serves as a professor in the New York Eye and Ear Infirmary of Mount Sinai.
Mr. Gandolfo has been serving as our Chief Financial Officer and Secretary since December 2017. Mr. Gandolfo has approximately 30 years of experience as a chief financial officer of multiple rapidly growing private and publicly held companies with a primary focus in the life sciences, healthcare and medical device areas. Mr. Gandolfo has had direct responsibility over capital raising, including multiple public offerings, financial management, mergers and acquisition transactions and SEC reporting throughout his professional career. Prior to joining us, Mr. Gandolfo was Chief Financial Officer of Xtant Medical Holdings, Inc. from July 2010 through September 2017. Prior to joining Xtant, he served as the Chief Financial Officer of Progenitor Cell Therapy LLC, a manufacturer of stem cell therapies, from January 2009 to June 2010. Prior to joining Progenitor, Mr. Gandolfo served as the Chief Financial Officer of Power Medical Interventions, Inc. (acquired by Covidien plc, which was in turn acquired by Medtronic plc), a publicly held developer and manufacturer of computerized surgical stapling and cutter systems, from January 2007 to January 2009. Prior to joining Power Medical Interventions, Mr. Gandolfo was the Chief Financial Officer of Bioject Medical Technologies, Inc. (NASDAQ: BJCT), a supplier of needle-free drug delivery systems to the pharmaceutical and biotechnology industries, from September 2001 to May 2006, and served on the Bioject’s board of directors from September 2006 through May 2007. Prior to joining Bioject, Mr. Gandolfo was the Chief Financial Officer of Capital Access Network, Inc., a privately held specialty finance company, from 2000 through September 2001, and Xceed, Inc. (OTC: EXDW), an Internet consulting firm, from 1999 to 2000. From 1994 to 1999, Mr. Gandolfo was Chief Financial Officer and Chief Operating Officer of Impath, Inc., a then publicly held, cancer-focused healthcare information company. From 1987 through 1994, he was Chief Financial Officer of Medical Resources, Inc., a then publicly held manager of diagnostic imaging centers throughout the United States. Mr. Gandolfo received his B.A. in business administration from Rutgers University. He is a certified public accountant (inactive status) who began his professional career at Price Waterhouse.
Jennifer "Ginger" Clasby
VP of Clinical Operations
Ms. Clasby has worked in the field of regulated medical products during most of her career and has been serving as our Vice President, Clinical Operations since September 2017. From 2009 to September 2017, she served as Vice President, Clinical & Regulatory Affairs/Quality Assurance at Transcend Medical, an early stage, venture backed company developing novel products for management of glaucoma, which was acquired by Alcon in May 2016. In that position, she was responsible for overseeing clinical operations and regulatory processes for the company’s clinical trials in the United States, Europe and Latin America, as well as worldwide regulatory affairs, quality assurance and compliance activities. She was also a pivotal executive with Promedica International, a contract research organization, from 1994 to 2009. Prior to that, Ms. Clasby worked with ophthalmic device companies American Medical Optics and Optical Radiation Corporation in various roles for approximately 14 years in the areas of clinical affairs, manufacturing operations, marketing and sales. She serves on the University of California-Irvine Extension Life Science Advisory Committee. She holds an M.S. degree in Industrial Engineering from Arizona State University and B.S. degrees in mathematics and physics from Guilford College.
VP of Engineering
Mr. Clauson has been serving as our Vice President, Research & Development and Manufacturing since August 2017. He founded a medical device-focused engineering development company, Innovative Drive Corporation, that has helped businesses of all sizes conceptualize and bring dozens of products to market, including several in ophthalmology, in 2004 and has been serving as its President since then. Mr. Clauson has been the President and a director of Inspire products, Inc. since 2012 and also serves on the board of directors of Mimic Motion, Inc. From 2016 until 2018, he was Chief Operating Officer of ianTECH. From 2009 to 2016, Mr. Clauson was Vice President, Research & Development and Operations at Transcend Medical, which developed a micro-stent for glaucoma and was acquired by Alcon. He started his engineering career at Cardica, Inc. (now Dex Liquidating Co.), where he ultimately directed product development for the core anastomotic business. Mr. Clauson has extensive experience in designing, validating, achieving regulatory approval and scaling for commercialization with multiple products. He holds a B.Sc. in mechanical engineering from the University of California, Davis.
Lee Kramm, MD
VP of Regulatory Affairs
Dr. Kramm has been serving as our Vice President of Regulatory Affairs since July, 2017. From 2007 to 2012, Dr. Kramm served as a medical officer and scientific reviewer in the Division of Ophthalmic, Neurological and ENT Devices in the Center for Devices and Radiological Health, FDA. In his position as a medical officer at FDA, Dr. Kramm reviewed a variety of ophthalmic devices and served on several internal FDA working groups whose goal was to improve and bring consistency to premarket regulation and clinical evaluation. During his tenure at FDA, Dr. Kramm reviewed pre-IDEs, IDEs, PMAs, 510(k)s, Humanitarian Use Designations (HUD), Humanitarian Device Exemptions (HDE), Class I/II device recalls, combination products and requests for designation (RFD). Dr. Kramm is a board certified ophthalmologist. He received his general and surgical training in ophthalmology from the Rocky Mount Lions Eye Institute at the University of Colorado in Denver, his M.D. from the University of Miami School of Medicine, and B.Sc. and M.Sc. dual degrees in biomedical engineering from the Tulane University School of Engineering.
VP of Commercial
Mr. Rowe brings his extensive experience in ophthalmic drug and device marketing and development to our mission of “Making it PossibleTM.” Mr. Rowe had been serving as our Vice President, Marketing since July 2018. In October 2019, Mr. Rowe assumed additional duties and his title was changed to VP, Commercial. From February 2016 to June 2018, he was head of Global Strategic Marketing, Ophthalmology at Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), where he was responsible for the United States and international commercialization, planning and execution for Rhopressa®, for the lowering of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Previously, he spent 12 years at Allergan plc in various roles supporting corporate strategic initiatives as well as strategic planning for the company’s worldwide glaucoma franchise, including the development of bimatoprost SR and the global launch of Ganfort® UD. Mr. Rowe also has held senior marketing roles at Bayer Healthcare Pharmaceuticals Inc., Women First Healthcare, Inc. and Pfizer Inc (NYSE: PFE). Mr. Rowe holds an M.Sc. in human factors/experimental psychology from Rensselaer Polytechnic Institute and a B.A. in psychology from the State University of New York at Stony Brook.