Notal Vision announces publication of first prospective longitudinal pilot study of daily self-imaging with patient-operated Home OCT in wet AMD patients

Manassas, VA (July 13, 2021) - Notal Vision, Inc. announced today that results from the first prospective longitudinal pilot study of daily, home-based self-imaging with their investigational, patient-operated Home OCT for wet age-related macular degeneration (AMD) patients have been published in Ophthalmology Science.1 The technology is designed to provide retina specialists with remote retinal OCT scans and fluid volume trajectories to support the management of patients with wet AMD, complementing existing standard of care treatments as well as emerging longer acting drugs and drug delivery systems.

The study evaluated the ability of subjects to perform sequential daily self-imaging of their eyes with the user-friendly, tele-connected and self-operated Notal Home OCT device in their homes. Daily OCT images were automatically transmitted to the Notal Health Gould and processed for signs of disease activity by the Notal OCT Analyzer (NOA), an artificial intelligence image processing algorithm that identifies, quantifies and maps fluid in the retina.

"Daily home OCT imaging reveals a high degree of heterogeneity in terms of the dynamics of fluid exudation and resolution," said Prof. Anat Loewenstein, Director of the Department of Ophthalmology at Tel Aviv Medical Center (Ichilov) in Tel Aviv, Israel. "Typically a clinical decision is inferred from single time points of OCT imaging. With home OCT, we as clinicians will be able to base our decisions on enormous qualitative and quantitative data with greater insights in disease activity between office visits. Home OCT may allow highly personalized retreatment decisions with fewer unnecessary injections and clinic visits."

Led by Prof Loewenstein, the pilot study in Israel followed four patients undergoing routine anti-VEGF therapy for wet AMD in one or both eyes for up to three months. Out of 240 self-imaging attempts 87.9% were successful, and of these 97.6% had satisfactory image quality. For fluid presence, NOA agreed with human grading in 94.7% of cases. From a subset of 24 scans with fluid, for agreement between NOA and human fluid volume measurements, the correlation coefficient was 0.996 and mean absolute difference 1.5 nl (vs 0.995 and 1.2 nl, respectively, for inter-human agreement). Graphical plots of fluid volume revealed wide variation in the dynamics of fluid exudation and treatment response.

"We thank the investigators for their pioneering efforts and laying the foundation for a new paradigm in patient management," said Dr. Kester Nahen, Chief Executive Officer of Notal Vision, Inc. `The successful demonstration of all elements required for a Home OCT monitoring system in this longitudinal home-based study has allowed us to embark on several ongoing larger scale trials with pharmaceutical companies that are using our investigational home monitoring service," he added.
Notal Vision`s home-based OCT pipeline technology received FDA Breakthrough Device designation at the end of 2018, and is in the process of obtaining FDA clearance. In January 2020 the American Medic Association established three category III Current Procedural Terminology (CPT^) codes for reporting patient-initiated remote retinal OCT scans, facilitated by Notal Vision`s home-based OCT. The physiciar review, interpretation and documentation of Al-based analyses will be billable every 30 days.

Reference:
1 Keenan TDL, Goldstein M, Goldenberg D, Zur D, Shulman S, Loewenstein A. Prospective longitudinal pilot study: daily self-imaging with patient-operated home OCT in neovascular age-related macular degeneration. Ophthalmology Science 2021 (in press), https://doi.Org/10.1016/i.xops.2021.100034