A ventilator-compatible nitric oxide generator and delivery system, called AirNOvent, for patients with pulmonary hypertension and related conditions, will be made available by Circassia Pharmaceuticals to hospitals in the U.S. and China next year. This is made possible through a $32.5 million commercial license agreement signed with AIT Therapeutics.
Nitric oxide (NO) plays an essential role in several biological functions. At specific concentrations, it aids in immune function to fight infections, and plays a role as a pulmonary vasodilator, thus improving oxygen uptake. Inhaled NO is an FDA-approved treatment for people with persistent pulmonary hypertension (PH).
“We look forward to working with a highly skilled Circassia team to bring this revolutionary product to market,” Steve Lisi, chairman and chief executive officer of AIT Therapeutics, said in a press release.
In hospitals, inhaled NO is made available in high-pressure cylinders. AirNOvent — a portable medical device — eliminates the need for bulky cylinders, reducing the liability and safety concerns associated with the transport and maintenance of such heavy medical equipment. The device was designed for the treatment of persistent PH of the newborn (PPHN) and other related conditions at concentrations of less than 80 parts per million.
AirNOvent can generate sufficient concentration of NO using the available oxygen and nitrogen in the air. Also, it can detect and eliminate small amounts of toxic NO2 generated during the process, making the device easier and safer to use compared to the pressurized cylinders.
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As part of the licensing agreement, AIT will receive payments after certain predetermined stipulations have been met. The company will receive royalties based on Circassia’s profit after any future sales.
AIT expects to submit AirNOvent for U.S. Food and Drug Administration (FDA) pre-market approval (PMA) in the second quarter of this year. In the PMA process, the FDA conducts a scientific and regulatory review of the safety and efficacy of a medical device. After PMA approval, AirNOvent is anticipated to be available for hospital use in the U.S. in early 2020.
“We, along with Circassia, anticipate entering the U.S. market in the first half of 2020, given FDA typically rules on PMA approvals 180 days post-submission,” Lisi said.
AirNOvent is not an approved name for the product, and therefore might not be the final name submitted for approval.