Notal Vision Reports Results from First U.S. Home OCT Feasibility Study

Manassas, VA (October 12, 2021) - Notal Vision, Inc. reported today that results of the first U.S.-based feasibility study with its investigational home-based optical coherence tomography (OCT) platform were presented at the Retina Society and the American Society of Retina Specialists (ASRS) annual meetings. The Notal Home OCT pipeline technology is designed to provide patient-initiated retinal OCT scans to support the management of patients with wet age-related macular degeneration (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 with wet AMD to perform sequential daily self-imaging of their eyes for three months with the user-friendly, self-operated, tele-connected Notal Home OCT device following self-setup in their homes. Images from the device were securely and automatically transmitted via a built-in cellular modem to the Notal Health Cloud and remotely reviewed by study investigators via the secure web viewer. OCT images were then processed for identification and quantification of retinal fluid, a key biomarker in wet AMD, by the proprietary Notal OCT Analyzer (NOA ) deep learning algorithm.
The feasibility study showed the device`s ease of use, good image quality, compliant self-imaging and spatio-temporal tracking of retinal fluid in an elderly wet AMD patient population. These results confirm findings from the longitudinal pilot study reported by Keenan et al. in Ophthalmology Science earlier this year.

"Patients ability to self-image and generate high quality OCT scans at home for remote physician review was impressively demonstrated in this wet AMD population", said Jeffrey S. Heier, MD, one of the study`s principal investigators and director of the retinal service and retinal research at Ophthalmic Consultants of Boston. "Insights in disease dynamics and treatment response gained from Al-based analysis of up to daily home OCT images provide opportunities for personalized treatment and accelerated development of new drugs."

"Home OCT patient monitoring has great potential to help reduce treatment burden on patients and caregivers supporting long-term adherence to therapy and improved outcomes", said Nancy Holekamp, MD, co-principle investigator of the study and director of retina services at Pepose Vision Institute. "The remote monitoring services that patients receive from digital health providers allow retina specialists to extend their care to the patient`s home."

"The results of the first U.S. study confirm the key target product profile requirements of our Home OCT program," said Kester Nahen, PhD, CEO of Notal Vision, Inc. "We would like to thank Genentech, a member of the Roche group, for their financial support of the study and are excited to progress on our path toward FDA clearance of the system."