Mallinckrodt and Novoteris Receive Clearance from Health Canada to St art Pilot Trial of High-Dose Inhaled Nitric Oxide Therapy for COVID-19 Infection and Associated Lung Complications

— Study to investigate antiviral activity and improvement in oxygenation and pulmonary arterial pressure in patients suffering from COVID-19 — pulmonary arterial pressure in patients suffering from COVID-19 — STAINES-UPON-THAMES, United Kingdom and GARDEN GROVE, CA – April 1, 2020 — Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, and Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, today announced that the Therapeutic Products Directorate of Health Canada has cleared the companies’ joint pilot clinical trial, entitled “Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19)…

Continue Reading Mallinckrodt and Novoteris Receive Clearance from Health Canada to St art Pilot Trial of High-Dose Inhaled Nitric Oxide Therapy for COVID-19 Infection and Associated Lung Complications

Novoteris Investigator Receives Health Canada Clearance to Start a Phase 2a Clinical Trial of its Thiolanox® Nitric Oxide for the Treatment of Non-Tuberculous Mycobacteria (NTM).

Garden Grove, CA—October 31, 2017:  Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced today that the Therapeutic Products Directorate of Health Canada has cleared an investigator sponsored, pilot clinical trial application exploring the treatment of Non-Tuberculous Mycobacteria (NTM) with Novoteris’ Thiolanox inhaled nitric oxide gas, using its unique computerized trace-gas delivery system. This single center open label trial will recruit 10 subjects to the Vancouver clinical site. This trial will enable the testing of nitric oxide in patients who have this debilitating disease and who are excluded from the Novoteris…

Continue Reading Novoteris Investigator Receives Health Canada Clearance to Start a Phase 2a Clinical Trial of its Thiolanox® Nitric Oxide for the Treatment of Non-Tuberculous Mycobacteria (NTM).

Novoteris, LLC. Receives FDA and Health Canada Clearance to Start a Phase 2 Clinical Trial of its Thiolanox® Nitric Oxide for the Treatment of Cystic Fibrosis.

Garden Grove, CA—June 5, 2017:  Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced today that both the US Food and Drug Administration and the Therapeutic Products Directorate of Health Canada have cleared its Phase 2 clinical trial application. Novoteris will now begin recruiting subjects into its Phase 2 trial that will be using inhaled nitric oxide for the treatment of Cystic Fibrosis (CF). This multi-center trial will randomize sixty subjects recruited from five cystic fibrosis research centers (Seattle, Los Angeles, Milwaukee, Charleston and Vancouver) to either Thiolanox® nitric oxide product…

Continue Reading Novoteris, LLC. Receives FDA and Health Canada Clearance to Start a Phase 2 Clinical Trial of its Thiolanox® Nitric Oxide for the Treatment of Cystic Fibrosis.