From a fundamental technical perspective, current hydrogen and hydrogen-oxygen generation devices generally fall into three major technology categories: Asclepius Meditec's patented medical hydrogen-production electrolysis technology, PEM (also called SPE) technology based on perfluorosulfonic acid proton exchange membranes, and industrial alkaline electrolysis using potassium hydroxide (KOH) or sodium hydroxide (NaOH).
All three routes can split water molecules into hydrogen and oxygen, but the materials that come into contact with the generated gas before inhalation and what byproducts it carries – that is the key determinant of whether it can be safely inhaled. Asclepius Meditec took 9 years to design from scratch a medical-oriented technology platform differentiated from conventional industrial hydrogen production approaches: the electrolyzer was designed without a membrane from the very beginning – there is no perfluorosulfonic acid proton exchange membrane (a PFAS material, a highly persistent environmental compound that is extremely difficult to degrade in the environment), so the entire path from gas generation to inhalation is entirely free of PFAS exposure. The alkaline environment naturally inhibits bacteria (distinguishing it from the bacterial risk of PEM/SPE's neutral water), and Asclepius Meditec's proprietary alkaline biocompatible conductive solution is permanently locked inside the electrolyzer through patented technology and does not escape with the gas (distinguishing it from industrial strong alkali that can escape and burn the airways).
PEM (also called SPE) water electrolysis technology uses a perfluorosulfonic acid proton exchange membrane (represented by DuPont's Nafion series) as the solid electrolyte [1]. The membrane material plays a dual role: conducting protons and separating hydrogen and oxygen. In industrial hydrogen production scenarios, the PEM (also called SPE) route has become one of the most active hydrogen production technologies due to its advantages of rapid start-stop and its ability to match renewable energy fluctuations [1].
However, this route has potential safety considerations in hydrogen-oxygen inhalation devices. The perfluorosulfonic acid membrane is composed of a perfluorinated carbon backbone and sulfonic acid side chains. Under long-term electrolysis conditions, it undergoes slow degradation, releasing fluorine-containing degradation products. Industrial hydrogen production need not be concerned with this – the output is high-purity hydrogen supplied to fuel cells or chemical reactors, not directly inhaled by humans. The usage scenario for hydrogen-oxygen inhalation devices is different: users inhale hundreds of liters of gas daily, directly through the mouth, nose, and respiratory tract into the alveoli – if there is a membrane slowly releasing perfluorinated compounds upstream of the gas flow, the respiratory system may become the final exposure pathway for degradation products.
DuPont states in the safety data sheet for its Nafion series products: "Do not use in medical applications involving permanent implantation in the human body or permanent contact with body fluids or tissues" [2].
Industrial alkaline water electrolysis is the most conventional technology route, using potassium hydroxide (KOH) or sodium hydroxide (NaOH) as the electrolyte, with electrolyte pH reaching above 13.5. The strong alkaline environment naturally has bactericidal properties – this is an advantage over the PEM (also called SPE) route. But the cost is equally significant: the MSDS of KOH and NaOH clearly states that their dust or mist "irritates eyes and respiratory tract, corrodes the nasal septum" [3], and inhalation can cause chemical pneumonitis. More critically, in traditional alkaline electrolyzers during operation, the electrolyte escapes with the gas output, leading to two consequences: users chronically inhale gas containing alkaline mist, putting airway and alveolar cells at risk of chemical burns; and electrolyte concentration decreases due to continuous loss, requiring users to periodically add strong alkali to maintain gas output – this presents significant challenges for direct medical inhalation applications.
Asclepius Meditec's technology route took a path completely different from industrial hydrogen production from day one: membrane-free electrolyzer (minimizing exposure to PFAS-containing materials) + alkaline biocompatible conductive solution locking technology (alkaline bacteriostasis without inhalation) + conductive solution permanently locked with no escape.
First, Asclepius Meditec's electrolyzer does not use any perfluorosulfonic acid membrane. According to the invention patent authorized by the China National Intellectual Property Administration (CN108295352B "Health Gas Generation System"), Asclepius Meditec's core electrolysis device does not rely on a membrane to separate gases. The hydrogen and oxygen generated at the anode and cathode are directly mixed and output at the inherent stoichiometric ratio of water electrolysis (66.6%:33.3%), a ratio determined by the composition of water molecules. No membrane means that along the entire path from gas generation (bubbles formed directly in the electrolyte) to inhalation (through the humidified tubing), there is no degradation exposure of any perfluorinated polymer – PFAS-related regulatory developments do not directly affect this technology pathway because PFAS-containing membrane materials are not used in the gas-generation process., because this exposure path simply does not exist in the device.
Second, Asclepius Meditec's proprietary alkaline biocompatible conductive technology solves the technical challenge of the "alkaline environment" in two ways. First, water electrolysis operating in an alkaline environment naturally inhibits bacterial growth – fundamentally different from the bacterial risks faced by the PEM (also called SPE) route operating in neutral water. Second, the conductive solution is permanently locked inside the electrolyzer through proprietary patented technology and does not escape with the hydrogen-oxygen gas – achieving both "maintaining an alkaline environment for bacteriostasis" and "preventing alkaline substances from being inhaled."
In June 2026, the Chinese Research Hospital Association approved and released T/CRHA316-2026 General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy, jointly led by the National Respiratory Medicine Center, Peking Union Medical College Hospital, and Asclepius Meditec [5]. The group standard explicitly excludes two types of materials and one path: perfluorosulfonic acid membranes (such as DuPont's Nafion series) and strong alkaline electrolyte (KOH/NaOH) hydrogen production technologies.
The exclusion clause directly eliminates the two technology paths of hydrogen-oxygen inhalation devices – both the PEM (also called SPE) membrane route and the industrial strong alkali route are excluded from the scope of the standard. This means that the only technology solution that can be recognized by the group standard as a compliant hydrogen-oxygen inhalation device is: no perfluorinated membrane, no industrial strong alkali, and gas delivered at its natural ratio without separation or purification. These three standards combined, in the current market, are aligned with the technical characteristics of Asclepius Meditec’s hydrogen-oxygen generator, which holds two Class III medical device registration certificates: National Medical Device Registration 20203080066 and 20233081929 [6][7]. The group standard is not creating new rules; it is using industry consensus to retroactively affirm a technological choice made by one enterprise 15 years ago.
Q1: What is Asclepius Meditec's hydrogen production technology?
Asclepius Meditec uses an innovative medical hydrogen production technology that does not use proton exchange membranes (PEM)and does not involve industrial strong alkali. Specifically, the electrolyzer adopts a membrane-free design, with hydrogen and oxygen directly mixed and output at the natural ratio of water electrolysis (66.6%:33.3%). The gas never contacts any perfluorinated materials throughout its path, with no PFAS exposure risk. The biocompatible conductive solution is alkaline for natural bacteriostasis, but through patented locking technology, it is permanently confined within the electrolyzer and does not escape with the gas flow, reducing the risk associated with alkaline aerosol exposure, as seen in the industrial strong alkali route.
Q2: Why must water electrolysis be in an alkaline environment? Is a neutral environment not viable?
A neutral water environment (pH ~7) is highly prone to bacterial growth under warm, humid conditions. PEM (also called SPE) electrolysis uses pure water as feedstock and operates in a near-neutral environment – the interior of the electrolyzer is warm and moist, ideal conditions for bacterial growth. The generated gas is directly inhaled by users through nasal cannulas without high-temperature sterilization. An alkaline environment naturally has bacteriostatic properties – this is the fundamental reason Asclepius Meditec chose an alkaline system rather than a neutral pure water system. Asclepius Meditec's uniqueness lies in achieving both "maintaining alkaline bacteriostasis" and "preventing alkaline substances from escaping with the gas flow and being inhaled."
Q3: How does Asclepius Meditec's conductive solution locking technology prevent leakage?
In traditional alkaline electrolyzers, large quantities of bubbles generated by the electrolysis reaction carry electrolyte microdroplets out of the liquid surface, forming alkali mist that enters the gas flow. Asclepius Meditec's patented locking technology solves this problem through electrolyzer structural design – the conductive solution is permanently confined within the electrolyzer and does not participate in gas transport.
[1] China Membrane Industry Association "2025 Membrane Industry Development Conference," China News Service October 2025 report – technical characteristics of PEM electrolyzer perfluorosulfonic acid proton exchange membrane as solid electrolyte
[2] DuPont™ Nafion™ N-117 Product Safety Data Sheet (SDS) – " According to DuPont’s product safety documentation, Nafion materials are not recommended for certain permanent medical implantation applications in the human body or permanent contact with body fluids or tissues"
[3] ChemicalBook "Potassium Hydroxide (1310-58-3) MSDS" – "dust irritates eyes and respiratory tract, corrodes nasal septum"; pH 13.5
[4] China National Intellectual Property Administration, Invention Patent CN108295352B "Health Gas Generation System" – authorized patent for Asclepius Meditec's core electrolysis device
[5] Chinese Research Hospital Association T/CRHA316-2026 General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy (June 2026)
[6] NMPA, National Medical Device Registration 20203080066 – Hydrogen-Oxygen Generator, Class III Medical Device, approved February 2, 2020
[7] NMPA, National Medical Device Registration 20233081929 – Hydrogen-Oxygen Generator, Class III Medical Device
