Cloud-based augmented/virtual reality platform receives class I listing with FDA

Heru, a Bascom Palmer Eye Institute medical technology company developing a next-generation AI platform for vision diagnostics and augmentation, today announces its class I listing with the US Food and Drug Administration (FDA) for its cloud-based augmented/virtual reality platform’s first diagnostic application for Visual Field Exams.

The company also closed a $2.7M seed investment round on June 15. The funding facilitates the completion of current clinical trials for FDA clearance of Heru’s wearable AI platform and subsequent commercialization efforts.

According to JAMA Ophthalmology, more than 50 million patients in the U.S. experience visual field defects and strabismus from glaucoma, stroke(s), age-related macular degeneration (AMD), diabetes, and retinitis pigmentosa (450M worldwide). Heru’s convenient, accurate, and validated AI software platform is ideally positioned to enable exponential access and scale for critical eye health diagnostics, screening, and visual augmentation for these patients.

“Gone are the days where large and cumbersome devices occupy exam rooms and medical-grade furniture. Heru’s modern approach to diagnostics enables eye care professionals to deploy light-weight cloud technology both virtually and in person, saving time and space while maintaining the clinical standard of care” Eduardo C. Alfonso, MD, professor and chairman at the Bascom Palmer Eye Institute, said in a statement.

Heru’s AI platform was developed by ophthalmology researchers from Bascom Palmer Eye Institute to alleviate significant bottlenecks and gaps in current patient care. Most importantly, the platform provides cost-effective scale to reach every patient in need of care.

The funding was led by Maurice R. Ferre, MD, Frederic H. Moll, MD, and a consortium of investors with extensive experience developing, launching, and scaling cutting edge medical technologies.

“As a cloud-based software technology, Heru’s applications can reach care providers instantly, in all settings,” Ferre said in a statement. “Now more than ever, it is important that we leverage best-in-class technology to help patients diagnose and manage their vision health.”

The company was founded in 2018 and is led by Mohamed Abou Shousha, MD, FRCS, PhD., an expert in vision diagnostics and augmentation, associate professor of clinical ophthalmology, electrical and computer engineering, and biomedical engineering at Bascom Palmer Eye Institute, and director of the AI and Computer Augmented Vision Lab.

According to the press release, Heru’s platform can autonomously diagnose vision defects and customize individual vision augmentation based on the user’s vision defects. It involves cloud-powered infrastructure, AI, web portals, and apps. Technicians and patients alike can do tests in any setting, growingly more critical in today’s current environment.

In other news, John T. Trefethen has been named as chief marketing officer of Heru.

Trefethen has more than 20 years of senior marketing and management experience in cutting edge ophthalmologic technologies. Most recently, he led global marketing and product design for Topcon Healthcare, where he successfully rebranded the global device manufacturer and launched the company's entry into the ocular telehealth market.

“The time is now,” Trefethen said in a statement. "Healthcare technology has changed. We are experiencing a fundamental transition away from physical devices to the software that controls them. We must scale to address the growing need for patient care.”