PeriVision CE Marking to kickstart sales in Europe

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01.11.2024

PeriVision, an innovative spin-off from the University of Bern and the University Hospital Bern, has received the EU CE-certification for its 1st medical software product VisionOne. The startup addresses the large unmet clinical need for more efficient and patient-friendly 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.

With VisionOne, ophthalmologists and optometrists can easily configure visual field tests on portable VR headsets and subsequently analyze the results on a cloud platform. Algorithms optimize the eye tests, automate assistance and control quality. At the core of the product lies PeriVision’s patented visual field-testing algorithm SORS (Sequentially Optimized Reconstruction Strategy). In clinical studies it has demonstrated the ability to reduce test time dramatically, while maintaining high accuracy.

Patrick Kessel, Perivision’s CEO, emphasises that the CE-certification was achieved after a substantial effort to prove the safety, efficacy, and clinical impact of the VisionOne device: “Given that the EU has probably the most demanding regulatory requirements in the world, we achieved this milestone in a comparatively short time. This success was in the end also possible through the incredible efforts of our regulatory team and the know-how and support from our regulatory partners Effectum Medical. Now, we look forward to bringing VisionOne’s diagnostic capabilities and benefits to patients and eye doctors across Europe.”

Sales off to a good start

The CE-mark opens the door for Perivision to expand its market presence across Europe, bringing its innovative diagnostic technology to clinicians and patients in need. Speaking of sales, PeriVision CEO tells Startupticker.ch: “we already signed distributors with unit commitments in Switzerland, Liechtenstein, Spain, Greece, Cyprus, the UK and have clinics that have placed orders through the distributor or directly with us.”

Regarding the business model, PeriVision has two models. A SaaS subscription model in which customers will pay a yearly software license and a more traditional sales model, where there is a one-time up-front payment, and a small service fee. 

(ES)

Picture: PeriVision at American Academy of Ophtalmology in Chicago 

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