Update regarding Beyond Air product approvalSource: RNS
Circassia Group PLC
("Circassia" or the "Company")
Update regarding Beyond Air product approval
Oxford, UK - 29 June 2022: Circassia Group PLC (AIM: CIR), a company engaged in the design, development and commercialisation of medical devices for the diagnosis and management of asthma, notes the announcement yesterday from BeyondAir, Inc. (NASDAQ: XAIR) ("BeyondAir"), confirming that it had received approval from the U.S. Food and Drug Administration (FDA) for its LungFit® PH device ("Approval") for the treatment of hypoxic respiratory failure in neonates using nitric oxide generated from ambient air.
As a result of this news and in accordance with the terms of a previously announced settlement agreement1 between Circassia and BeyondAir, the Company is entitled to receive payments of $10.5 million in total, in three instalments as follows:
· $2.5m within 60 days of Approval; plus
· $3.5m within 60 days of the first anniversary of Approval; plus
· $4.5m within 60 days of the second anniversary of Approval.
In addition, Circassia is entitled to a royalty of 5% of net sales of the device, commencing on the second anniversary of Approval, up to a maximum of $6m.
For further information, please contact:
Circassia Group plc
Ian Johnson, Executive Chairman
Michael Roller, Chief Financial Officer
+44 (0) 1865 405560
Singer Capital Markets (Nominated Adviser & Broker)
Aubrey Powell / Jen Boorer
+44 (0) 20 7496 3000
Our ambition is to improve the quality of life of millions of people suffering from asthma. The company is engaged in the design, development and commercialisation of medical devices for the diagnosis and management of asthma. Today our device, NIOX VERO, is used by healthcare professionals and leading research organisations. We passionately believe in empowering everyone to manage their health at home and are developing NIOX for home use to meet this need. At present, Circassia provides products and services in around 50 countries. For more information please visit www.circassia.com.