Investing in the Most Urgent Need in Modern Neuropsychiatry – Treatment of Alzheimer’s Disease
Overview
Cogniguard is developing a new approach to the treatment of Alzheimer’s disease based on a well-established neuromodulation method, vagus nerve stimulation.
Vguard was developed for use during sleep, with the aim of leveraging the important role of sleep in memory consolidation, a process affected in Alzheimer’s disease.
Rather than relying solely on pharmacological approaches, Vguard uses neuromodulation during sleep with the aim of influencing brain activity associated with memory and cognitive processes.
Our development activities are supported by European Union innovation funding and long-term collaboration with clinical research centers.
Cogniguard operates a certified ISO 13485 quality management system. Vguard is a Class IIa medical device CE marked in accordance with the MDR, supporting its regulatory pathway and commercialization in the European market.
Market Opportunity
- More than 55 million people worldwide live with dementia, with Alzheimer’s disease accounting for 70% of cases.
- In the United States, the disease currently affects 7 million people, and this number is expected to double by 2050.
- The global economic burden amounts to $1.3 trillion annually.
- Medicare and Medicaid costs in the United States currently amount to $230 billion, with projections indicating an increase to $650 billion by 2050.
Current Alzheimer’s treatments:
- Provide only temporary relief from symptoms
- Are associated with serious adverse effects (38–48%)
- Cost between $20,000 and $30,000 per year
What Makes Vguard Different?
Unlike ineffective pharmacological therapies, Vguard offers the first approach targeting the core symptoms of Alzheimer’s disease, memory loss and cognitive decline, through non-invasive vagus nerve stimulation.
The device has been designed with patients with cognitive impairment in mind and features an easy-to-use neurostimulator controlled via a mobile application. Therapy is continuously monitored through an advanced cloud-based system that collects stimulation parameters in real time and enables caregivers to easily track adherence to the treatment plan.
Our advantages
Scientific Validation and Clinical Progress
- 7 granted patents (4 in the US, 2 in China, and 1 in the EU) protecting key intellectual property
- First scientific demonstration of type II theta activity in the hippocampus induced by vagus nerve stimulation in an animal model
- Stimulation patterns developed through proprietary preclinical research
- Initial clinical validation in humans demonstrated significant improvements in memory and other cognitive functions, substantially exceeding the effects of existing pharmacological treatments
- Therapy was well tolerated, with only minor adverse effects
- A complete list of scientific publications is available under NDA
Grants and Strategic Partnerships
- Support from EU innovation grants for research, development, and clinical programs
- Collaboration with leading universities and hospitals
- EU medical market approval: in 2025, Vguard became the world’s first CE-MDR certified approach for the treatment of Alzheimer’s disease and mild cognitive impairment (MCI)
- Active communication with the U.S. FDA, including preliminary regulatory guidance regarding the certification pathway
Milestones & Roadmap
2016
Awarded EU R&D Grant
Secured European funding to pioneer breakthrough neurotechnology research.
2017
Launch of Preclinical Animal Trials
Initiated rigorous safety and efficacy testing to validate therapeutic potential.
2018
Discovery of Theta Rhythm via Vagal Nerve Stimulation
Identified a groundbreaking neural mechanism with implications for cognitive regeneration.
2019
First Peer‑Reviewed Scientific Publication (1 of 7)
Shared pioneering results with the global scientific community, reinforcing academic credibility.
fMRI Validation Trials
Conducted advanced imaging studies to demonstrate measurable brain activity changes.
2020
First‑in‑Human Clinical Trial (60 Patients, Poland)
Began clinical evaluation of safety and efficacy in Alzheimer’s patients.
2023
Clinical Trial at Israeli Alzheimer’s Center
Expanded international research footprint with a leading medical institution.
CE Certification Process with TÜV Rheinland & V2 Development
Entered formal European regulatory pathways while preparing next‑generation technology.
2025
CE MDR Certification Achieved
Officially certified under the EU Medical Device Regulation, ensuring compliance and trust.
Start of V3 Mass Production
Transitioned from prototype to scalable manufacturing for broader accessibility.
2026
Multicenter Clinical Trial Across Europe
Strengthening evidence base with large‑scale, multi‑site patient studies.
2027
European Market Launch
Introducing Cogniguard technology to healthcare providers across the EU.
U.S. Pivotal Trial
Initiating FDA‑aligned pivotal study to prepare for U.S. market entry.
2028
U.S. Market Launch
Bringing Cogniguard innovation to American patients and clinicians.
Publications & Research
For a full list of our peer-reviewed publications, including hippocampal
VNS stimulation feferences available in the Clinical & Scientific section or under NDA.
Media & Press Releases
Stay connected via:
- Our official LinkedIn page for thought leadership and updates
Let’s Talk – Under NDA
We welcome contact from qualified investors. Detailed clinical, regulatory,
and financial data is available following the signing of a Non-Disclosure Agreement.
Contact: info@cogniguard.com
This section presents publicly available information only.