DUBLIN--(BUSINESS WIRE)--Presbia PLC (NASDAQ:LENS), an ophthalmic device company that has developed and is currently marketing the Presbia Flexivue Microlens™, a proprietary optical lens implant for treating presbyopia, announced today that it has appointed Dumitra Nela Gonzales as Vice President of Regulatory Affairs and Quality Assurance. Ms. Gonzales was previously the Director of Quality Assurance of Presbia since 2013.
“Nela will continue to lead the team in documenting the Presbia Flexivue Microlens™ consistent with ISO standards to further enhance the alignment of regulatory and marketing requirements with our corporate business strategy,” said Todd Cooper, President and CEO of Presbia. “Additionally Nela will assist the expansion of Presbia’s global business portfolio by seeking to acquire registrations in key target markets by strategically driving a sustainable and compliant quality system.”
Ms. Gonzales has more than 20 years of experience in quality assurance in the medical and pharmaceutical industries. Prior to joining Presbia, Ms. Gonzales was the Director of Quality Assurance and Compliance for Critical Care and Vascular at Edwards Lifesciences, managing all aspects of quality assurance. Prior to Edwards Lifesciences, she was a Director of Corporate Quality Assurance Compliance at Abbott Medical Optics Inc., responsible for quality assurance compliance for the AMO Division of Abbott.
Ms. Gonzales is a certified Lead Auditor by the British Standards Institute (BSI) in ISO 9001 with emphasis in ISO 13485, and holds a Bachelor of Science in Chemistry from the University of Bucharest.
Information provided and statements contained in this press release that are not purely historical are forward-looking statements. Such forward-looking statements only speak as of the date of this press release and Presbia assumes no obligation to update the information included in this press release. Statements made in this press release that are forward-looking in nature may involve risks and uncertainties. Accordingly, readers are cautioned that any such forward-looking statements are not guarantees and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Although Presbia believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Unless otherwise required by law, Presbia also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made in this press release.
Presbia PLC (NASDAQ:LENS) is an ophthalmic device company that has developed and is currently marketing the presbyopia-correcting Presbia Flexivue Microlens™, a miniature lens that is implanted in a corneal pocket created by a femtosecond laser. The Presbia Flexivue Microlens™ has received a CE mark for the European Economic Area, allowing the lens to be marketed in over 30 countries across Europe. A staged pivotal U.S. clinical trial for the Presbia Flexivue Microlens™ commenced in 2014.