01/07/2025: VIS, Inc. files a Provisional Patent Application (PPA) for a device and procedure for the treatment of myopia with the United States Patent and Trademark Office (USPTO).
10/07/2024: VIS, Inc. receives its Medical Device Single Audit Program (MDSAP) Certification. The MDSAP is an international initiative based on the quality management system standards outlined in ISO 13485 that allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities. For more information please visit: https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap.
10/04/2024: VIS, Inc. receives its ISO 13485:2016 Certification. This means that VIS, Inc. has implemented and maintains a Quality Management System for Medical Devices. The certificate covers the following activities: Design and development, manufacturing, distribution, installation and servicing of active systems for eye care procedures.
09/23/2024: The Ethics Review Board for VIS, Inc. and Opti-K™, approves the Health Canada Investigational Testing Authorization (ITA) for the Treatment of Presbyopia. Principal Investigator training is scheduled for 09/26/24. Patient screening and treatments for presbyopia are scheduled for October Q4 2024.
08/26/2024: Health Canada Approves the Opti-K™ Investigational Testing Authorization (ITA) For the Treatment of Presbyopia.
08/09/2024: Based on the approved Investigational Testing Authorization (ITA) for Age-Related Macular Degeneration (AMD), VIS, Inc. installs and calibrates the Opti-K™ system at our Toronto clinical site and Chief Medical Officer Harry Glen MD trains the Principal Investigator on the Opti-K™ procedure. Patient screening and treatments for AMD are scheduled for October Q4 2024.
07/02/2024: VIS, Inc. receives a structured equity investment to finance US and Canadian operations including clinical site initiation, regulatory efforts, and system manufacturing.
05/03/2024: VIS, Inc. launches patient screening for the Opti-K™ Phase IIIa Pivotal Study.
05/01/2024: VIS, Inc. releases a Private Placement Memorandum (PPM) Class D Preferred Convertible for Accredited investors.
04/17/2024: VIS LLC, a Texas Limited Liability Company, converts to VIS, Inc., a Texas C-Corporation.
01/01/2024: The Opti-K™ procedure is the Cover Story for Cataract & Refractive Surgery Today (CRST) A New Approach to Thermal Keratoplasty.
12/20/2023: Health Canada Approves The Opti-K™ Investigational Testing Authorization (ITA) for the Treatment of Age-Related Macular Degeneration (AMD).
04/19/23: FDA Approves The Opti-K™ Investigational Device Exemption (IDE) for the Phase III FDA Pivotal Study for the Treatment of Presbyopia.
