Investing in the Most Urgent Need in Modern Neuropsychiatry – Treatment of Alzheimer’s Disease

Overview

Cogniguard is, for the first time, offering real hope for an effective treatment of Alzheimer’s disease by targeting a well-established and safe neuromodulation method: vagus nerve stimulation.

Our therapy has been specifically designed for nighttime use, taking advantage of the critical role sleep plays in memory consolidation — a process profoundly disrupted already in the earliest stages of Alzheimer’s disease.
Unlike pharmaceutical options that provide only temporary symptomatic relief, Vguard aims to improve cognitive status by activating memory-related brain functions during sleep.

We are supported by European Union innovation funding and long-standing partnerships with
leading clinical research centers.

Market Opportunity

Market Opportunity

    • Over 55 million people worldwide live with dementia; 70% have Alzheimer’s
    • 7 million Americans affected today; numbers expected to double by 2050
    • Annual global economic burden: $1.3 trillion
    • US. Medicare & Medicaid costs: $230B today, projected to reach $650B by 2050

Current Alzheimer’s drugs:

      • Offer only temporary symptomatic relief
      • Have severe adverse effects (38–48%)
      • Cost between $20K–$30K/year

How Vguard Differs

VGuard, unlike ineffective pharmacological treatments, offers the first method targeting the core symptoms of Alzheimer’s disease — memory loss and cognitive decline — through non-invasive vagus nerve stimulation.

The device is designed for cognitively impaired patients and features an easy-to-use neural stimulator controlled by a mobile app. The entire therapy is continuously monitored by a sophisticated cloud-based system that collects real-time stimulation parameters and allows caregivers to effortlessly track treatment compliance.

Competitive Landscape

Therapy TypeRouteSettingAdverse EventsCognitive Benefit
Biologic Drugs 
(e.g., Biogen, Eisai)IVClinic38–48% SAE~1.4 ADAS-Cog points @ 18 mo
TMS (Brainsway, Nexstim)Non-invasiveClinic18% SAENon-significant
AV Therapy (Cognito Tx)Non-invasiveHome13–15% AENon-significant
VGuard (Neuromedical)Non-invasive (night use)Home6% minor AE6-point gain @ 12 weeks

Scientific Validation & Clinical Progress

  • 7 granted patents (4 US, 2 China, 1 EU) protecting core IP
  • First neuroscientific demonstration of hippocampal theta II activation via vagus nerve stimulation in an animal model
  • Stimulation patterns developed through proprietary preclinical studies
  • First-in-human clinical validation shows meaningful improvements in memory and other cognitive functions, significantly outperforming existing drugs
  • Well tolerated with only minor side effects
  • Full publication record available under NDA

Grants & Strategic Partnerships

    • Supported by EU innovation grants for R&D and clinical programs
    • Collaborations with leading universities and hospitals
    • EU medical market approval — VGuard became the first globally CE-MDR-cleared method (2025) for the treatment of Alzheimer’s disease and Mild Cognitive Impairment
    • Active communication with the U.S. FDA, with initial certification guidance received
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Milestones & Roadmap

Awarded EU R&D Grant
Secured  European funding to pioneer breakthrough neurotechnology research.

2016

Launch of Preclinical Animal Trials
Initiated rigorous safety and efficacy testing to validate therapeutic potential.

2017

Discovery of Theta Rhythm via Vagal Nerve Stimulation
Identified a groundbreaking neural mechanism with implications for cognitive regeneration.

2018

First Peer‑Reviewed Scientific Publication (1 of 7)
Shared pioneering results with the global scientific community, reinforcing academic credibility.

2019

fMRI Validation Trials
Conducted advanced imaging studies to demonstrate measurable brain activity changes.

First‑in‑Human Clinical Trial (60 Patients, Poland)
Began clinical evaluation of safety and efficacy in Alzheimer’s patients.

2020

Clinical Trial at Israeli Alzheimer’s Center
Expanded international research footprint with a leading medical institution.

2023

CE Certification Process with TÜV Rheinland & V2 Development
Entered formal European regulatory pathways while preparing next‑generation technology.

CE MDR Certification Achieved
Officially certified under the EU Medical Device Regulation, ensuring compliance and trust.

2025

Start of V3 Mass Production
Transitioned from prototype to scalable manufacturing for broader accessibility.

Multicenter Clinical Trial Across Europe
Strengthening evidence base with large‑scale, multi‑site patient studies.

2026

European Market Launch

Introducing Cogniguard technology to healthcare providers across the EU.

 

 

2027

U.S. Pivotal Trial
Initiating FDA‑aligned pivotal study to prepare for U.S. market entry.

U.S. Market Launch
Bringing Cogniguard innovation to American patients and clinicians.

2028

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Publications & Research

For a full list of our peer-reviewed publications, including hippocampal
VNS stimulation and cognitive performance improvement, please
contact us.

References available in the Clinical & Scientific section or under NDA.

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Media & Press Releases

Stay connected via:

  • WhitePress pressroom for press releases & media kits
  • 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.