AIT Therapeutics said that it has received a $3.15 million milestone payment from Circassia Pharmaceuticals after successful completion of a pre-submission meeting with the FDA for AirNOvent nitric oxide delivery system. Circassia recently announced that it had acquired US and Chinese rights to the product.
In a separate announcement, Circassia said that it will issue new ordinary shares in the company to make the milestone payment to AIT.
The FDA has designated AirNOvent as a medical device. According to Circassia, AIT plans to submit a premarket approval application to the FDA in the second quarter of 2019 for the use of AirNOvent for the treatment of respiratory failure due to persistent pulmonary hypertension of the newborn (PPHN).
AIT Chairman and CEO Steve Lisi said, “We are very excited about our recently signed commercial licensing agreement with Circassia. Receipt of this milestone payment is another example of AIT’s ability to execute. We remain on track to make our PMA submission to the FDA in the second quarter of 2019 and anticipate a US launch in the first half of 2020.”
Circassia CEO Steve Harris said, “Successful completion of this pre-submission meeting represents a further key milestone in advancing AirNOvent towards the market. We are excited at the potential benefits offered by AirNOvent, once approved, and look forward to AIT submitting this novel nitric oxide product for regulatory approval in the coming months.”
Read the AIT Therapeutics press release.
Read the Circassia Pharmaceuticals press release.
