Broncus Holding Corp.’s thermal vapor treatment system Intervapor has won approval from China’s NMPA. The system is used for the treatment of chronic obstructive pulmonary disease (COPD), lung cancer and other pulmonary diseases.
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
LONDON – Breath biopsy specialist Owlstone Medical Ltd. closed a $58 million oversubscribed series D, bringing the total raised by the company since its formation in 2016 to over $150 million. The money will support further development of tests for lung cancer, liver disease and respiratory disease, and of a new class of diagnostics, which rather than measuring endogenous markers of disease, involve administering chemical probes and assessing how they are metabolized.
DUBLIN – Verona Pharma plc is adding $25 million cash to its balance sheet, as well as $15 million worth of stock in Nuance Biotech Co. Ltd., and could earn up to $179 million more in milestones linked to the development in the greater China region of ensifentrine, its candidate maintenance therapy for chronic obstructive pulmonary disorder (COPD).
HONG KONG – Coreline Soft Co. Ltd. has taken its first step into the Greater China market after receiving approval from Taiwan’s Food and Drug Administration (TFDA) on April 8 for its Aview suite of artificial intelligence (AI) medical solutions.
The management team at Respinova Ltd. is breathing easier with the FDA's 510(k) clearance of the company's Pulsehaler. Using pulsed air pressure, the device opens airways and clears secretions in patients with respiratory diseases. The clearance represents the device’s first endorsement by a regulatory agency, though the company hopes it will soon be joined by others.
PERTH, Australia – Sydney-based Cyclopharm Ltd. raised AU$30 million (US$23.19 million) in a private placement that will enable the company to launch its Technegas combination product in the U.S.
TORONTO – The Medipines AGM100, which was developed by Orange County, Calif.-based Medipines Corp. to detect respiratory impairment caused by chronic obstructive pulmonary disease (COPD), has been recruited in the fight against COVID-19 in Canada. Described by company CEO and coinventor Steve Lee as “the world's first noninvasive lung monitor for gas exchange measurement,” the device is undergoing advanced testing.
Royal Philips NV is reporting the launch of Philips Ventilator Bipap A40 EFL, a noninvasive ventilator that aims to help patients with chronic obstructive pulmonary disease (COPD) breathe easier. With its CE mark in hand, the company has tagged initial target markets as France, Italy and the U.K. Additional European markets are expected to come next year.
DUBLIN – Verona Pharma plc raised $200 million in a combined private placement and share subscription, which ensures the London-based firm has the funds in place to proceed with a phase III program for its lead drug candidate, ensifentrine, as maintenance therapy in chronic obstructive pulmonary disease (COPD). It’s solid evidence that the company’s decision to bring in a new senior management team earlier this year is working. CEO David Zaccardelli and Chief Financial Officer Mark Hahn joined up in February, not long after they had led specialty pharma firm Dova Pharmaceuticals Inc. to a buyout deal with Stockholm-based Swedish Orphan Biovitrum AB, worth up to $915 million.
