Theia Imaging Secures $2.1M NIH Award to Bring Ultra-widefield OCT Angiography to the Bedside

The Loris T2 ultra-widefield lens is able to capture a 145 degree volumetric OCT.

Theia Imaging has received a two-year Small Business Innovation Research (SBIR) Phase II award of approximately $2.1M from the National Eye Institute. The funding supports development of an angiography module for the company's Loris T2 handheld OCT platform, and carries the program through a pivotal study and a 510(k) submission to the U.S. Food and Drug Administration.

OCT angiography (OCTA) maps the retina's blood vessels in depth-resolved detail without dye injection, instead detecting the motion of blood cells across rapid, repeated scans. That approach demands dense sampling and near-perfect stillness from the patient — which is why OCTA today lives almost exclusively on tabletop instruments used with cooperative adults seated at a chinrest.

Yet the patients with the most to gain from vascular imaging are often the ones those instruments exclude. Premature infants at risk for retinopathy of prematurity, young children, and older or critically ill patients frequently cannot hold position for a conventional scan, leaving clinicians without a practical way to assess retinal perfusion, vascular development, or neovascularization in the very populations where such diseases cause preventable vision loss.

The OCTA program tackles this gap with an OCTA engine with increased imaging speed; enhanced imaging depth; neural network-based segmentation of the retinal vasculature; and a guided capture workflow that helps imagers acquire motion-free scans at the bedside.

The new award will also support the development of segmentation algorithms for quantitative measurement of retinal anatomy, functionality that has been out of reach for clinicians managing the care of infants and young children. 

The support extends a line of NIH-supported development at Theia that produced the swept-source OCT engine and interchangeable lenses at the heart of the Loris T2. With the OCTA module, the company aims to put state-of-the-art widefield vascular imaging directly into the hands of clinician-scientists and caregivers, opening a window onto retinal disease in patients who could never access it before.

The Loris T2 is Theia Imaging’s handheld swept-source OCT platform built around a 300KHz imaging engine, and a lightweight probe that accepts interchangeable lenses — including an ultra-widefield option with a 145-degree field of view. The Loris T2 has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration, a status reserved for technologies with the potential to provide more effective diagnosis of life-threatening or irreversibly debilitating conditions, which affords priority review and closer interaction with FDA during development. The system can be seen in action here.

The T2 Handheld OCT system is under development and has not been cleared or approved by the FDA. It is available for research use only.  

The content of this press release is solely the responsibility of Theia Imaging and does not necessarily represent the official views of the National Institutes of Health.