saniva diagnostics receives approval from the US FDA for its medical product NeuroMex

Xlife Sciences AG / Key word(s): Miscellaneous/Regulatory Approval

16-Feb-2023 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

Medical Screening Device Set to Measure Complex Neurocognitive Performance for Early Detection of Severe Neurodegenerative Diseases Such as Parkinson's or Alzheimer's

saniva diagnostics, a portfolio company of Xlife Sciences (SIX: XLS), has received the 513(g) approval from the US Food and Drug Administration (FDA) to market and sell its proprietary screening device NeuroMex as a non-regulated medical device in the USA. NeuroMex is a patented screening instrument for cognitive performance and is used to interpret current cognitive performance in patients, which may include those at risk for developing neurodegenerative diseases such as Parkinson's or Alzheimer's disease.

Worldwide, more than 55 million people are affected by Parkinson's and Alzheimer's disease (including about seven million in the USA). With the NeuroMex system, saniva diagnostics offers a new solution for healthcare providers and their patients. The detection and interpretation of cognitive function in, for example, Parkinson's sufferers at an early stage enables them to receive targeted treatment at an early stage. Early detection of neurodegenerative diseases with NeuroMex makes it possible to save time in the treatment of people with the disease, improve their quality of life and at the same time reduce costs for the healthcare system.

The NeuroMex screening device is non-invasive, fast, and inexpensive and is used to investigate complex neurocognitive performance. It is particularly suitable for use as part of an annual health check-up procedure. The NeuroMex system quantifies an individual’s responsiveness during the one-handed catching of a suddenly falling stick. Equipped with sensors and controlled by software, the stick serves as a measuring device; the stick falls at a point in time that is unpredictable for the patient, making it possible to quantify visual-motor reaction performance. Various parameters are recorded in real-time with sensors. By comparing the individual performance with reference data from healthy individuals and with disease-specific thresholds, the individual neuro-cognitive function can ultimately be determined. At https://sanivadiagnostics.com/neuromex/?lang=en, a video showing how NeuroMex works is available.

Jenny Nisser, founder and CEO of saniva diagnostics GmbH, comments: “The launch of NeuroMex in the USA, the largest medical device market in the world, is an important milestone for saniva diagnostics. We are very excited about the progress we have made as a company and part of Xlife Sciences in just three years since our spin-off from Jena University Hospital. Our next goal to work with suitable partners to bring the NeuroMex technology to market worldwide and consequently help the unfortunately rapidly increasing population of people with Parkinson's and dementia by detecting the diseases at an early stage”.

Oliver R. Baumann, CEO of Xlife Sciences AG, adds: “We sincerely congratulate the team of our portfolio company saniva diagnostics on this milestone, which is also of relevance for Xlife Sciences. At the same time, we would like to thank the European Regional Development Fund, which supports the research and development activities of saniva diagnostics with funds from the European Union”.

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Annual Report 2022                  April 20, 2023

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Contact

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Information for investors: Xlife Sciences AG, Dennis Lennartz, dennis.lennartz@xlifesciences.ch

Xlife Sciences AG, 
Talacker 35, 
8001 Zurich, 
Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch, 
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange