Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams.

In a visual field exam, patients are assessed on their ability to use their central and peripheral vision, a test that helps clinicians diagnose conditions such as glaucoma and age-related macular degeneration. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.

The subjective visual field exam is the first application on Heru’s software platform, but other diagnostic tests are being developed.

The Heru platform has the potential to disrupt the way ophthalmology care is accessed by making advanced diagnostics available in almost any setting, from retail and pharmacy sites to a patient’s home. The combination of Heru software and wearable devices could potentially replace numerous large and expensive diagnostic machines currently housed in ophthalmology practices, explained John Trefethen, Heru’s chief marketing officer.

“What Heru is doing, and what this first registration is providing, is a way for us to extend the point of care to a very small footprint in the primary eye care space with very little need for advanced understanding about diagnostics,” Trefethen told BioWorld.

Use of this technology also would allow primary care eye providers to screen many more patients than they do today – and at a lower cost – he said.

AI technology platform

Heru is a spinoff company of the University of Miami’s Bascom Palmer Eye Institute, a top-ranked eye hospital in the U.S. Heru was founded by Mohamed Abou Shousha, who serves as president and CEO. Abou Shousha is a practicing ophthalmologist at the Bascon Palmer Eye Institute and has spent the last decade conducting the clinical and scientific research into the ophthalmic imaging and AI algorithms that underpin the Heru applications.

The company recently emerged from stealth mode following a $2.7 million seed investment round in June. The round was led by Maurice Ferre, CEO and chairman at Insightec; Frederic Moll, founder of Intuitive Surgical and Auris Health, and chief development officer at Johnson & Johnson; and a consortium of investors with experience in medical technology.

The funding is being used to help Miami-based Heru complete its current clinical trials, as well as begin commercialization efforts.

The company is launching a commercial pilot in several sites across the U.S. to test its “technology as a service” business model. Heru plans to distribute the hardware and software together with customers paying a subscription. As the technology advances, the hardware is replaced, and new applications are added or updated.

“We are a diagnostics platform. We are approaching medicine from the perspective of wearable technologies that allow us to provide various diagnostic services with a single device,” Trefethen said. “So, it’s not so much about the equipment anymore; it’s more about the software that runs on those devices.”

Through the pilot, the team is seeking to better understand how customers will accept the business model. If the pilot is successful, the company is planning a commercial launch of its subjective visual field exam in the second quarter of 2021, following a series A funding round.

The next application out of the gate will be an objective visual field exam, which uses a patient’s eye movement to evaluate central and peripheral vision. This is being validated in a clinical trial at the Bascom Palmer Eye Institute, and the company plans to seek 510(k) clearance from the FDA. This could be cleared as soon as the second quarter of 2021, Abou Shousha explained.

Also in the works is an augmentation application that would use AR/VR digital spectacles to correct a patient’s vision. Abou Shousha said the idea for this application came from his work seeing patients in the eye clinic. When patients with glaucoma come to the clinic, he can stop their vision deterioration, but not offer any vision restoration, which is frustrating for patients whose loss of peripheral vision may impair their ability to walk or engage in other daily activities, he said.

“The vision augmentation is using the diagnostics in order to identify and characterize and quantify the vision defect that the patient has, and then correct for it in the headset,” Abou Shousha said.

In a prospective study of 23 patients with glaucoma, Abou Shousha and colleagues assessed peripheral visual field expansion with novel VR digital spectacles. More than three-quarters of patients were able to identify safety hazards using the digital spectacles that they could not previously, researchers reported in the American Journal of Ophthalmology. Researchers also reported an improvement in identification and quantification of peripheral objects. Additional research was presented at the ARVO annual meeting in 2019 and 2020, and published in PLOS One and the American Journal of Ophthalmology. Heru’s clinical trial of the augmentation application at Bascom Palmer Eye Institute currently has more than 500 patients enrolled.

Abou Shousha said the company plans to file a de novo application with the FDA in the second quarter of 2022 for the vision augmentation technology.