11 August 2020 | News
Asclepius Meditec's hydrogen/oxygen generator has received the Class III Medical Device certificate from China's National Medical Products Administration
Image courtesy: PR Newswire
An innovative, environmentally friendly treatment with no side effects has been made available to COVID-19 patients, involving the electrolysis of H2O to produce a mixture of hydrogen and oxygen for human inhalation.
The results of the research as a treatment for COVID-19 were published in the June 2020 edition of the Journal of Thoracic Disease (JTD).
In a multicentered, open-label clinical trial described in the article entitled "Hydrogen/oxygen mixed gas inhalation improves disease severity and dyspnea in patients with Coronavirus disease 2019 in a recent multicenter, open-label clinical trial", inhalation of the hydrogen/oxygen mixture prevented the further progression of the disease and, most notably, alleviated the shortness of breath experienced by COVID-19 patients.
This is a retrospective study, which validated the efficacy and safety of inhaling a H2-O2 mixture in patients with COVID-19. The research and clinical trial associated with the study were led by Zhong Nanshan, China's leading pandemic control expert and head of the National Health Commission's expert group fighting COVID-19.
The clinical trial was conducted on 44 patients with COVID-19 whose dyspnea could not be ameliorated after regular treatment in 11 hospitals. After three days of continuous use of the hydrogen/oxygen Generator, AMS-H-03, a device manufactured by Shanghai-based Asclepius Meditec, all 44 patients showed significant improvement compared with 46 patients who received the standard regimen of oxygen alone.
Asclepius Meditec's hydrogen/oxygen generator has received the Class III Medical Device certificate from China's National Medical Products Administration. FDA and CE certification applications for the device are in process.
AMS-H-03 is a hydrogen/oxygen inhalation medical device that the Shanghai-based firm has been working on over a long period. The core technology is based on a new approach with proven safety which vastly reduces the likelihood of exacerbated pulmonary inflammatory response in COVID-19 patients.