03/20/2025: VIS, Inc. receives its Medical Device License (MDL) through Health Canada. The MDL allows VIS, Inc. to manufacture and sell the Opti-K™ device in Canada, import the device into Canada for sale, distribute the device through authorized channels (e.g., to distributors or healthcare providers), and market and advertise the device for its approved intended use, following Health Canada’s advertising rules.
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.
