H₂ Global Group announced that its subsidiary H₂ Medical Technologies has received official approval from The State Institute for Drug Control (SÚKL) to initiate a clinical study focused on molecular hydrogen inhalation therapy for patients with mild cognitive impairment (MCI), an early stage of Alzheimer's disease. This milestone represents Europe's first fully approved clinical trial investigating non-invasive hydrogen inhalation as a neuroprotective therapy.
Breakthrough Technology Based on Decades of Research
The project builds on pioneering research by Professor Shigeo Ohta, co-founder of H₂ Global Group and widely regarded as the founding father of therapeutic hydrogen medicine. Professor Ohta personally transferred his European patent (EP 3701956 B1), titled "Prophylactic or Therapeutic Agent for Dementia," to the Group.
"Launching a clinical study that directly builds on Professor Ohta's patent is both an honor and a responsibility," said PharmDr. Milan Krajíček, co-founder of H₂ Global Group. "This milestone proves that Czech innovation and research have truly a global relevance."
The company has developed what it claims is the world's first functional hydrogen-based therapy medical device prototype for clinical trials, aimed at both preventing and treating Alzheimer's disease.
Addressing Critical Unmet Medical Need
The global burden of Alzheimer's disease continues to escalate, with more than 6.5 million Americans and 50 million people worldwide currently living with Alzheimer's and other forms of dementia. According to the World Health Organization, this number could triple by 2050, placing an immense burden on families and healthcare systems.
"While several antibody-based drugs have been approved to slow Alzheimer's progression, there is still no widely available, safe, and effective non-invasive treatment," said David Maršálek, founder and CEO of H₂ Global Group. "Our goal is to offer patients and physicians a gentle, accessible, and scientifically validated solution."
Clinical Trial Design and Timeline
The six-month study will begin in January 2026 in cooperation with Professor David Školoudík, M.D., Ph.D., one of the Czech Republic's leading neurologists. The project aims to achieve the world's first regulatory registration of a medical device utilizing molecular hydrogen.
"This is not another experiment — it is the first technology in the world with the potential to prevent Alzheimer's disease before it even starts, while supporting those already affected," says Maršálek. The company believes its effectiveness will be further confirmed in the upcoming clinical trial.
Broader Applications and Market Expansion
While the immediate focus is Alzheimer's, potential applications extend to neurological disorders, brain regeneration, and healthy aging. H₂ Global Group has already launched consumer products such as H₂ Premium Water® and H₂ Brain®, described as a world-first two-phase dietary supplement that stimulates molecular hydrogen production through the gut microbiome.
The company's hydrogen-based solutions are already being adopted by wellness centers, rehabilitation clinics, dental practices, and elite sports organizations across Europe. H₂ Global Group is also the only certified global manufacturer authorized to use hydrogen-based medical devices in veterinary medicine.
Investment and Global Expansion
Until now, the project has been funded primarily by Czech investors. H₂ Global Group is now opening the door to U.S. and global partners at a critical growth stage, with EU registration underway and FDA approval next on the horizon, potentially unlocking access to the world's largest healthcare market.
The company will present this breakthrough at LSI Europe 2025 in London, one of the world's most prestigious MedTech and HealthTech conferences.
