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 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.
John 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 five 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 from July 2010 through September 2017. Prior to joining Xtant, he served as the Chief Financial Officer for 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 for Power Medical Interventions, Inc., 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., a publicly held 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., a publicly held 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 publicly held, cancer-focused healthcare information company. From 1987 through 1994, he was Chief Financial Officer of Medical Resources, Inc., a publicly held manager of diagnostic imaging centers throughout the United States. A graduate of Rutgers University, Mr. Gandolfo is a certified public accountant (inactive status) who began his professional career at Price Waterhouse.
VP of Clinical Operations
Jennifer “Ginger” Clasby has worked in the field of regulated medical products during most of her career. She 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 US, Europe and Latin America, as well as worldwide regulatory affairs, quality assurance and compliance activities. Previously, Ms. Clasby worked with ophthalmic device companies American Medical Optics and Optical Radiation Corporation in various roles in the areas of Clinical Affairs, Manufacturing Operations and Marketing/Sales. She was also a pivotal executive with Promedica International, a contract research organization, from 1994 to 2009. She serves on the University of California-Irvine Extension Life Science Advisory Committee. She holds an MS degree in Industrial Engineering from Arizona State University and BS degrees in Mathematics & Physics from Guilford College.
Luke Clauson has been serving as our Vice President, Research & Development 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 2014 and has been serving as its President since then. From 2009 to March 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, where he eventually 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 bachelor of science in mechanical engineering degree from the University of California, Davis.
Lee Kramm, MD
VP of Regulatory Affairs
Dr. Lee Kramm is a board certified Ophthalmologist with a Masters' degree in Biomedical Engineering. He earned his graduate degree from the Tulane University School of Engineering and his medical degree from the University of Miami School of Medicine. Following medical school he received general and surgical training in Ophthalmology from the Rocky Mountain Lions Eye Institute at the University of Colorado in Denver. Dr. Kramm served for five years 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).
VP of Marketing
Michael Rowe brings his extensive experience in ophthalmic drug and device marketing and development to Eyenovia’s mission of “Making it Possible™.” Prior to joining Eyenovia, Michael was responsible for leading the global glaucoma product strategy for Allergan and most recently the U.S. launch of Rhopressa® for Aerie Pharmaceuticals. For Michael, “Making it Possible™” means ensuring that diseases such as progressive myopia are finally addressed because of Eyenovia’s micro-dose technology.