H2 Global Group – Approval of the First SÚKL Clinical Trial for Molecular Hydrogen Inhalation
Molecular Hydrogen and Dementia Prevention: Czech Research Enters Its First Clinical Study
On 12 November 2025, a press conference of H2 Medical Technologies, part of H2 Global Group, was held at the ČTK PressCentre. At this event, we announced a major milestone – the approval of the first clinical study by the State Institute for Drug Control (SÚKL) in the Czech Republic, focused on inhalation of molecular hydrogen in patients with mild cognitive impairment (MCI).
Mild cognitive impairment is a condition that often precedes Alzheimer’s dementia. The possibility of early intervention at this stage is crucial – and molecular hydrogen may play an important role here. The study was also approved by the Ethics Committee of the University Hospital Ostrava, where it will be conducted.
👉 You can find the full ČTK article and the recording of the press conference here:
aktualne.cz
Reflex
České noviny:
https://www.ceskenoviny.cz/zpravy/2745785
Frekvence 1
Blesk pro ženy
Hospodařské noviny
https://domaci.hn.cz/c1-67811780-zive-molekularni-vodik-pro-prevenci-i-lecbu-kognitivnich-poruch
How Will the Study Be Conducted?
The approved clinical study is designed to accurately assess the safety and potential benefits of molecular hydrogen inhalation in patients with cognitive deficit.
Key parameters of the study:
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Start: January 2026
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Duration: 6 months
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Number of participants: approximately 30 patients
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Age range: 50–80 years
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Course:
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inhalation of molecular hydrogen 1 hour per day,
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5 times a week for 3 months,
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followed by a 3-month monitoring phase without active intervention.
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The study will assess:
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the safety of molecular hydrogen inhalation,
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changes in biochemical markers,
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the impact on cognitive functions,
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and quality of life from the patients’ own perspective.
Building on Japanese Research and a European Patent
This clinical study builds on the work of Professor Shigeo Ohta in Japan, one of the co-founders of H2 Global Group. His research led to the granting of European patent EP3701956B1 for the prophylaxis and treatment of dementia using molecular hydrogen.
Thanks to this patent, our development stands on a solid scientific and intellectual property foundation, which strengthens:
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the credibility of the technology,
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our position in the field of innovative therapeutic approaches,
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and the future potential for global adoption.
Czech Innovation with Global Impact
The approval of this clinical study is an important step towards achieving our goal – in 2026, we aim to introduce the world’s first medical device with molecular hydrogen, developed in the Czech Republic.
We then plan its expansion to other EU countries, the USA and Asia. This milestone:
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strengthens our scientific credibility,
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reinforces our regulatory position,
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and confirms that Czech know-how can play a significant role in global medicine, especially in the field of neurodegenerative diseases such as Alzheimer’s dementia.
We Are Looking for Volunteers for the Clinical Study
As part of today’s announcement, we are also launching a call for volunteers who wish to actively participate in the research and help advance future options for dementia prevention and treatment.
Who are we looking for?
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individuals aged 50–80 years,
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in overall good health,
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diagnosed with mild cognitive impairment up to mild or moderately severe dementia,
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ideally from Ostrava and the surrounding area (as the study will take place at University Hospital Ostrava).
How to apply?
Those interested can apply until 30 November 2025 by e-mail:
📧 david.skoloudik@H2medical.com
Our Vision and Thanks
This step would not be possible without the support of our partners, experts and investors who believe that molecular hydrogen can become a new, safe and non-invasive tool in the fight against the devastating impact of dementia.
We thank everyone who supports us on this journey and helps us develop Czech innovation with a truly global reach.