Source - Alliance News

Circassia Group PLC - Oxford, England-based medical device focused on point-of-care asthma diagnosis and management - Says BeyondAir Inc has won approval from the US Food & Drug Administration for its LungFit PH device, which is used for the treatment of hypoxic respiratory failure in neonates using nitric oxide generated from ambient air.

As a result of the approval and in accordance with the terms of a previously announced settlement agreement between Circassia and the New York-based biotech company, Circassia will receive total payments of $10.5 million. It is also entitled to a royalty of 5% of net sales of the device, up to a maximum of $6.0 million.

In May last year, Circassia and Beyond Air were in a dispute after Circassia licensed BeyondAir’s LungFit medical ventilation device. Circassia said it issued $10.5 million in shares to Beyond Air in the first half of 2019 under the agreement. But BeyondAir terminated the deal in December 2019 for material breach, which Circassia denied.

Under the settlement, Circassia has agreed to surrender its rights to LungFit in exchange for $10.5 million paid in instalments after the FDA approves the product. Beyond Air filed for FDA approval in November.

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