LungFit PH receives European CE mark approval to treat newborns
Approval includes its use for PH in patients undergoing heart surgery
LungFit PH, Beyond Air’s device for administering nitric oxide therapy, has received European CE mark approval for persistent pulmonary hypertension in newborns (PPHN).
This approval allows the company to market the device in the European Union and all other countries that recognize this certification, and also extends its use for pulmonary hypertension (PH) to people of all ages undergoing heart surgery to support right heart function. It was approved in the U.S. for PPHN in 2022.
“We are thrilled to announce CE mark for LungFit PH, paving the way for commercial sales in Europe and other global regions,” Steve Lisi, chairman and CEO of Beyond Air, said in a company press release.
PH refers to high blood pressure in the pulmonary arteries, the blood vessels that pass through the lungs. In PPHN, a newborn’s pulmonary arteries don’t open up enough, which increases blood pressure, strains the right side of the heart, and reduces oxygen delivery to the body.
Nitric oxide causes blood vessels to relax and widen, easing blood pressure
Nitric oxide, or NO, is a vasodilator, meaning it causes blood vessels to relax and widen, easing blood pressure. As a part of standard PPHN treatment, NO gas has been provided to patients using large pressurized canisters, which are bulky and difficult to maneuver.
Leveraging the company’s patented Ionizer technology, LungFit PH is designed to generate NO from the surrounding air, making treatment more convenient and easier to administer.
Under CE mark certification, the device is indicated specifically for infants born at 34 weeks of gestation or older with hypoxic respiratory failure (low blood oxygen) associated with clinical or echocardiographic evidence of PH. The treatment is designed to improve blood oxygen levels and reduce the need for extracorporeal membrane oxygenation, a type of support in which a patient’s blood is temporarily diverted to an artificial lung machine.
It has also been approved for PH associated with heart surgery in patients of all ages to lower pressure in the pulmonary arteries and improve right heart function.
LungFit PH system was recently dubbed an innovative technology by Vizient, a group of medical providers that identifies products that can substantially improve healthcare.
Under the terms of a commercialization agreement with Asia-Pacific distributor Getz Healthcare, Beyond Air will have access to hospitals in Australia, New Zealand, Thailand, the Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore, and Vietnam.
Upon CE mark approval, Getz will make a $1-million milestone payment to Beyond Air, which will also receive ongoing royalty payments based on LungFit PH net sales.
“In anticipation of this approval, we partnered with Business Asia Consultants to leverage their extensive international distribution network,” Lisi said. “I am incredibly proud of the team that made this happen over the past 30 months and look forward to initiating shipments to our Asia-Pacific partner, Getz Healthcare, and other international partners in 2025.”
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