Origin applies to China regulatory agency for clinical pathway classification
Princeton, New Jersey – October 24, 2019
Origin, Inc., a Phase III clinical-stage biotechnology company, today announced that it had applied to NMPA (formerly CFDA) for classification of its plasma-generated nitric oxide device for the purposes of conducting clinical trials in Hong Kong and mainland China, and that NMPA had accepted its submission. A determination is expected within sixty business days.
Origin is in preliminary discussions with clinical trial sites in Hong Kong and China in relation to clinical trials of its IonojetTM technology for the treatment of diabetic foot ulcers (DFU). It is anticipated that, if the discussions proceed to fruition, the trials would form part of the dataset required to progress the technology towards a potential future regulatory approval. The application for classification to NMPA, is a key first step in designing the DFU trials, which would be financed by investment from Hong Kong. In due course, Origin will look to conduct trials not just in DFU but also in other clinical indications.
Michael Preston, Chairman and CEO of Origin said “With the dramatic expansion of the diabetes epidemic in China, the incidence of DFU is growing proportionately, at great human cost to patients and financial burden to the Chinese healthcare system. With its ease of delivery, promising signal of efficacy from earlier trials in the US, and pricing flexibility, we believe that IonojetTM can potentially play a valuable role in combatting the devastating impact of DFU in China.” Details.
Dr David Dantzker to present Origin’s plasma-generated Nitric Oxide to the MEIDAM dermatology conference in Dubai on September 21, 2019
Princeton, New Jersey – Sep 15, 2019
Origin, Inc., a Phase III clinical-stage biotechnology company, today announced that Dr. David Dantzker, Vice Chairman and Chief Medical Officer of Origin, and former Chairman of the American Board of Internal Medicine, would be presenting Origin’s plasma-generated Nitric Oxide technology to The 4th Middle East International Dermatology & Aesthetic Medicine Conference & Exhibition (MEIDAM) on September 21, 2019. Details.