BEIJING – Med-tech firm Shanghai Asclepius Meditec Co. Ltd. says it has developed a hydrogen-oxygen nebulizer that can help relieve the shortage of ventilators, highlighting the potential of hydrogen-oxygen therapy in tackling COVID-19.

Named the AMS-H-03, this class III medical respiratory device can produce three liters of mixed gas containing hydrogen and oxygen by using water electrolysis and can run continuously for 24 hours, according to the company.

“The hydrogen-oxygen generator with nebulizer electrolyzes water into 66% hydrogen gas and 33% oxygen gas, with a flow rate of 3L/min, which is an upgrade on a normal ventilator,” Asclepius’ project manager Peggy Lai told BioWorld.

The device can be used alone or in combination via a trident joint. It can also be used in parallel with oxygen pipelines, invasive ventilators and noninvasive ventilators in hospitals.

In 2011, Asclepius began to study the treatment of various chronic diseases and tumors by letting patients inhale a mixture of hydrogen and oxygen.

The hydrogen-oxygen nebulizer was developed back in 2015. The company said the device has shown positive clinical results in the treatment for patients with acute exacerbation of chronic obstructive pulmonary disease or airway stenosis caused by bronchiectasis in a four-year human trial.

Now, Asclepius believes the hydrogen-oxygen nebulizer, which has been used to treat patients with mild to severe symptoms, could become one of the most vital adjuvant therapies for COVID-19.

Lai said 400 patients using this device have been evaluated across 20 hospitals in China. Among them, 259 COVID-19 patients were analyzed at three stages, namely admission to hospital, before treatment with hydrogen-oxygen nebulizers and after treatment with the device.

AMS-H-03 nebulizer. Credit: Shanghai Asclepius Meditec Co. Ltd.

In a real-world evidence analysis of the patients who inhaled the hydrogen-oxygen gas mix, Asclepius said results showed the device can improve the symptoms of chest pain, dyspnea, shortness of breath, cough, sputum and violent pneumonia in patients. In addition, it can reduce the risk of severe illness, shorten the length of hospital stay, and help patients to improve pulmonary fibrosis.

The company will also release the results of a GCP-compliant randomized controlled clinical trial of 150 subjects after data is collected in mid-April.

Asclepius’ director Xin-Yong Lin said the company’s engineers have overcome the problem of flammability caused by the hydrogen-oxygen mixture and witnessed the effect of the hydrogen-oxygen mixture as an auxiliary anti-inflammatory.

“We believe this is an extremely innovative treatment tool without any side effects, which is a result that all hydrogen medical experts have been looking forward to,” he said. “This is undoubtedly inspiring given the current lack of drugs for the novel coronavirus pneumonia.”

The use of hydrogen-oxygen therapy to tackle COVID-19 has been mentioned by Chinese medical experts. Wei-jie Guan, an expert from China’s National Clinical Research Center for Respiratory Disease, mentioned the therapy in a paper he co-authored titled Strategies for the Prevention and Management of Coronavirus Disease 2019 in The European Respiratory Journal.

“In light of the significantly decreased airway resistance and safety, inhalation of hydrogen and oxygen mixed gas which is generated through water electrolysis has been applied in clinical practice,” he said.

“Hydrogen-oxygen mixed gas inhalation resulted in a major amelioration of dyspnea in most patients with COVID-19 in a pilot investigation and has therefore been endorsed in the latest Recommendation for the Diagnosis and Management of Covid-19 document,” Guan said.

The document, released by China’s National Health Commission on March 3, 2020, suggested using timely provision of effective oxygen therapy, including by nasal catheter and mask oxygenation, and as nasal high-flow oxygen therapy, adding “if possible, inhalation of mixed hydrogen and oxygen (H2/O2: 66.6%/33.3%) can be applied.”

Some researchers believe this technology promises a cheap and conveninent method of producing a hydrogen-oxygen mixture, which has proved to be beneficial in the treatment of respiratory ailments.

“Patients treated with the inhalation of H2-O2 mixture felt significant improvement in chest pain and breathing. Given the lack and availability of effective drugs for COVID-19 and viral infection induced ROS, inflammation, cytokine storm and multi-organ failures, broader application of H2-O2 gas inhalation may save many lives,” said Shirley Wu, professor of Leslie Dan Faculty of Pharmacy at University of Toronto.

The company is now ready to mass-produce the device. Supported by Foxconn, Asclepius said one million hydrogen-oxygen nebulizers are on track to roll off production lines within 90 days.

Asclepius said its hydrogen-oxygen nebulizer can help in solving the worldwide ventilator shortage. Analytics company Globaldata estimates that about 880,000 more ventilators will be needed to deal with the demand. The U.S. needs about 75,000 ventilators, while France, Germany, Italy, Spain and the U.K. together need 74,000 devices.