As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus.
As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.
LONDON – Behold.ai Ltd. has secured U.S. FDA 510(k) approval for use of its Red Dot image recognition algorithm in the automatic diagnosis of life-threatening pneumothorax (collapsed lung). The product completes the analysis immediately, sending an alert to the radiologist as soon as an X-ray is taken. “It does in 30 seconds what would normally take up to 30 minutes,” said Simon Rasalingham, CEO of London-based Behold.ai.
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax (nitric oxide) inhaled gas to treat COVID-19-associated lung complications. INOmax is marketed in the U.S. by the Staines-upon-Thames, U.K.-based company to treat full- and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
PERTH, Australia – Australian medication adherence technology firm Adherium Ltd. is relaunching itself after a management reshuffle and a successful capital raise of AU$5.4 million (US$3.5 million) to deploy a new commercial strategy.
The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.
BEIJING – CF Pharmtech Inc., of Suzhou, China, closed a ¥630 million (US$90 million) series E financing round to bring its inhaled respiratory drugs to global markets and replace imports with homegrown products faster.
A Chinese study has established a previously unknown direct mechanistic link between elevated mechanical tension caused by impaired alveolar regeneration and progressive idiopathic pulmonary fibrosis (IPF), highlighting a pathogenic mechanism that may underlie fibrosis.
HONG KONG – Negev-based Ben-Gurion University (BGU) and Beersheba-based Soroka Medical Center in Israel, working with the Cincinnati Children's Hospital Medical Center and the University of Cincinnati (UC), have developed a technology for unblocking and removing secretions from airways to to treat patients with diseases affecting the respiratory tract.
LONDON – Mologic Ltd. has started recruitment in a 263-patient trial to validate its urine-based home test for anticipating exacerbations of chronic pulmonary obstructive disease (COPD). The lateral flow immunoassay self-test detects five biomarkers of the lung disease in urine that are indicative of inflammation and infection.