PeriVision FDA registration opens the way to markets

With VisionOne, ophthalmologists and optometrists can easily configure eye tests on portable VR headsets and subsequently analyze the results on a cloud platform. In the back-end AI algorithms optimize the eye tests, automate assistance, control quality and provide valuable insights for clinical decisions.

The FDA registration underscores PeriVision's commitment to meeting the highest standards of safety, efficacy, and quality in its medical software according to Dr. Ernest Cavin, a PeriVision board member with a long career in ophthalmology, most recently as CEO of Haag-Streit USA.

"We are thrilled to receive FDA registration for our latest medical device," said Dr. Ernest Cavin. "This milestone represents the culmination of years of research, development, and collaboration with leading institutions. We are confident that this technology will significantly impact the way eye tests are performed, ultimately improving patient outcomes."

PeriVision's FDA-registered device combines cutting-edge technologies such as AI, VR and eye tracking to address the needs of ophthalmologists, optometrists and their patients. PeriVision’s first product addresses the unmet clinical need for more efficient visual field testing, a routine eye test for glaucoma diagnosis and monitoring. With over 80 million living with the disease, glaucoma is the leading cause of irreversible blindness globally. Dr. Kevin Gillmann, PeriVision’s Chief Medical Officer and a glaucoma specialist himself, emphasizes that this market registration is the starting point on a longer-term roadmap.

“We want to develop a holistic platform comprising a portfolio of eye tests and AI tools to assist ophthalmologists and optometrists in their daily work. Our ultimate goal is to build software tools that improve patient experience, disease management and clinic productivity.”

Product launch in full swing already

With this approval, healthcare providers can now confidently integrate this innovative solution into their practice, offering patients access to state-of-the-art care. The team launched its product in the USA at the Vision Expo East Conference in New York City last week.

The team also participates in a national procurement challenge by the UK NHS to pilot remote glaucoma monitoring patient pathways to reduce the burden on overwhelmed central hospitals. This will help to broaden access to glaucoma services. As for Switzerland, PeriVision will be starting an early access program in fall 2024, where eye doctors and optometrists can benefit from attractive rates and support with the integration of the novel diagnostic tool into their workflows.

Overall, the idea is to use this commercial traction to raise additional funds in Q4 2024 to advance a global commercialization and extend the VisionOne platform to new eye tests and indications.

(PR - ES)