Beyond Air Receives CE Mark in Europe for the LungFit® PH System
Beyond Air (NASDAQ: XAIR) has received European CE mark approval for its LungFit® PH system, a nitric oxide generator for treating newborn infants with hypoxic respiratory failure and peri- and post-operative pulmonary hypertension. This approval enables marketing in the EU and other regions recognizing CE certification. The approval triggers a $1 million milestone payment from Asia-Pacific partner Getz Healthcare, with whom Beyond Air has a commercialization agreement covering multiple Asian markets. The LungFit PH system generates nitric oxide from ambient air using Ionizer® technology, eliminating the need for tanks or chemicals, and operates with minimal power consumption equivalent to a 60-watt light bulb.
Beyond Air (NASDAQ: XAIR) ha ricevuto l'approvazione CE europea per il suo systema LungFit® PH, un generatore di ossido nitrico per il trattamento di neonati con insufficienza respiratoria ipossica e ipertensione polmonare peri- e post-operatoria. Questa approvazione consente la commercializzazione nell'UE e in altre regioni che riconoscono la certificazione CE. L'approvazione attiva un pagamento di traguardo di 1 milione di dollari da parte del partner Asia-Pacifico Getz Healthcare, con il quale Beyond Air ha un accordo per la commercializzazione che copre diversi mercati asiatici. Il sistema LungFit PH genera ossido nitrico dall'aria ambientale utilizzando la tecnologia Ionizer®, eliminando la necessità di serbatoi o sostanze chimiche, e funziona con un consumo energetico minimo equivalente a una lampadina da 60 watt.
Beyond Air (NASDAQ: XAIR) ha recibido la aprobación CE europea para su sistema LungFit® PH, un generador de óxido nítrico para tratar a recién nacidos con fallo respiratorio hipóxico e hipertensión pulmonar peri y postoperatoria. Esta aprobación permite la comercialización en la UE y en otras regiones que reconocen la certificación CE. La aprobación desencadena un pago por hitos de 1 millón de dólares de su socio de Asia-Pacífico Getz Healthcare, con quien Beyond Air tiene un acuerdo de comercialización que abarca múltiples mercados asiáticos. El sistema LungFit PH genera óxido nítrico a partir del aire ambiental utilizando la tecnología Ionizer®, eliminando la necesidad de tanques o productos químicos, y opera con un consumo de energía mínimo equivalente a una bombilla de 60 vatios.
비욘드 에어 (NASDAQ: XAIR)는 렁핏® PH 시스템에 대한 유럽 CE 마크 승인을 받았습니다. 이 시스템은 저산소 호흡 부전과 수술 전후의 폐 고혈압으로 고통받는 신생아를 치료하기 위한 질산염 생성기입니다. 이 승인은 EU와 CE 인증을 인정하는 기타 지역에서의 마케팅을 가능하게 합니다. 승인은 아시아 태평양 파트너인 Getz Healthcare로부터의 100만 달러의 이정표 지급을 촉발하며, Beyond Air는 여러 아시아 시장을 포괄하는 상업화 계약을 체결하고 있습니다. LungFit PH 시스템은 Ionizer® 기술을 사용해 주변 공기에서 질소 산화물을 생성하며, 탱크나 화학물질이 필요 없고, 60와트 전구에 해당하는 최소 전력 소모로 작동합니다.
Beyond Air (NASDAQ: XAIR) a obtenu l'approbation du marquage CE européen pour son système LungFit® PH, un générateur d'oxyde nitrique pour le traitement des nouveau-nés souffrant d'insuffisance respiratoire hypoxique ainsi que d'hypertension pulmonaire péri- et post-opératoire. Cette approbation permet la commercialisation dans l'UE et d'autres régions reconnaissant la certification CE. L'approbation déclenche un paiement de jalon de 1 million de dollars de la part du partenaire Asie-Pacifique Getz Healthcare, avec lequel Beyond Air a un accord de commercialisation couvrant plusieurs marchés asiatiques. Le système LungFit PH génère de l'oxyde nitrique à partir de l'air ambiant grâce à la technologie Ionizer®, éliminant ainsi le besoin de réservoirs ou de produits chimiques, et fonctionne avec une consommation d'énergie minimale équivalente à une ampoule de 60 watts.
Beyond Air (NASDAQ: XAIR) hat die europäische CE-Kennzeichnung für sein LungFit® PH-System erhalten, einen Stickstoffmonoxid-Generator zur Behandlung von Neugeborenen mit hypoxischer Ateminsuffizienz sowie peri- und postoperativer pulmonaler Hypertonie. Diese Genehmigung ermöglicht den Vertrieb in der EU und in anderen Regionen, die die CE-Zertifizierung anerkennen. Die Genehmigung löst eine Meilensteinzahlung von 1 Million Dollar von dem Asien-Pazifik-Partner Getz Healthcare aus, mit dem Beyond Air eine Vermarktungsvereinbarung für mehrere asiatische Märkte hat. Das LungFit PH-System erzeugt Stickstoffmonoxid aus der Umgebungsluft mit der Ionizer®-Technologie, wodurch der Bedarf an Tanks oder Chemikalien entfällt, und es arbeitet mit einem minimalen Energieverbrauch, der dem einer 60-Watt-Glühbirne entspricht.
- CE mark approval enables market access in EU and other regions
- Immediate $1 million milestone payment from Getz Healthcare
- Future royalty payments based on LungFit PH net sales
- Access to multiple Asian markets through Getz Healthcare partnership
- Commercial sales won't begin until 2025
- to specific patient populations and medical conditions
Insights
The CE mark approval for LungFit® PH represents a significant market expansion opportunity for Beyond Air. The system's innovative approach to generating nitric oxide from ambient air eliminates the need for traditional gas cylinders, offering both operational and cost efficiencies for healthcare facilities. The
The dual indication approval for both neonatal and cardiac surgical applications broadens the potential market reach significantly. The technology's ability to generate NO on-demand with minimal power consumption (equivalent to a 60-watt light bulb) positions it favorably in the current healthcare environment where both clinical efficacy and sustainability are prioritized. The 2025 commercial launch timeline in international markets provides adequate preparation time for market penetration strategies.
This regulatory milestone opens up significant market opportunities across the EU and Asia-Pacific regions. The addressable market includes both neonatal intensive care units and cardiac surgery centers, representing a substantial expansion from the current US-only operations. The Getz Healthcare partnership provides access to 10 key Asian markets, leveraging established distribution networks for faster market penetration.
The system's operational benefits - unlimited on-demand NO generation, quick filter changes and broad dosage range (0.5-80 ppm) - present compelling value propositions for healthcare facilities. The sustainability angle, eliminating cylinder transport and storage, aligns with growing environmental consciousness in healthcare procurement decisions. For a company with a
Indication covers newborn infants with hypoxic respiratory failure and peri- and post-operative pulmonary hypertension to improve right ventricular function in conjunction with heart surgery
A
GARDEN CITY, N.Y., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, today announced European CE mark approval of the LungFit® PH system. This CE mark approval allows Beyond Air to market LungFit PH in the European Union and all other countries that recognize this certification. LungFit PH, the first device in the LungFit therapeutic platform of nitric oxide generators, leverages the company’s patented Ionizer® technology and has already received FDA approval in the United States.
“We are thrilled to announce CE mark for LungFit PH, paving the way for commercial sales in Europe and other global regions. In anticipation of this approval, we partnered with Business Asia Consultants to leverage their extensive international distribution network,” stated Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “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.”
Under the terms of Beyond Air’s existing commercialization agreement with Getz Healthcare for LungFit PH, Getz will make a
The specific indications for LungFit PH under CE Mark certification include:
1) the treatment of infants > 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.
2) the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function.
LungFit PH uses Ionizer technology to generate unlimited on-demand NO from ambient air and deliver it to a ventilator circuit, regardless of dose or flow. The device uses a compressor to drive room air through a plasma chamber where pulses of electrical discharge are created between two electrodes. The LungFit PH system ionizes the nitrogen and oxygen molecules, forming NO with low levels of nitrogen dioxide (NO2) created as a byproduct. The gas is then passed through a Smart Filter, which removes toxic NO2 from the internal circuit.
LungFit PH represents a significant step forward in sustainable healthcare solutions. Since the device generates NO conveniently and cleanly from ambient air, without the need for tanks or chemicals, it is highly energy-efficient, using only the power equivalent to a 60-watt light bulb. By eliminating the emissions associated with truck transport and cylinder refills, LungFit PH supports hospital sustainability initiatives, helping facilities reduce their carbon footprint while delivering critical care to patients.
For the approved indications, the novel LungFit PH system is designed to deliver a dosage of NO to the lungs that is consistent with the current standard of care for delivery of 20 ppm NO, with a range of 0.5 ppm – 80 ppm (low concentration NO) for ventilated patients. Each Smart Filter will last 12 hours regardless of ventilator demands, and replacing a filter only takes seconds.
Potential customers can visit the LungFit PH website, www.lungfitph.com, for additional information, including the product label, and to sign up for updates.
About Beyond Air®, Inc.
Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval and CE Mark for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure and peri- and post-operative pulmonary hypertension to improve right ventricular function in conjunction with heart surgery (EU only, see below for more information)*. Beyond Air is currently advancing its other revolutionary LungFit systems for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM) among others. Also, the Company has partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Additionally, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.
About LungFit®*
Beyond Air’s LungFit is a cylinder-free, phasic flow generator and delivery system and has been designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.
* Beyond Air’s LungFit PH is approved for commercial use in the United States of America to treat term and near-term neonates with hypoxic respiratory failure and in the European Union to treat infants > 34 weeks gestation with hypoxic respiratory failure associate with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation and for the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function. Beyond Air’s other LungFit systems are not approved for commercial use and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.
About Nitric Oxide
Nitric Oxide is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
Forward Looking Statements
This press release contains “forward-looking statements” (as defined in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended). You can identify such forward-looking statements by the words “appears,” “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including those related to the completion of the offering, risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Air undertakes no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Investor Relations contacts
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
FAQ
What is the CE mark approval for Beyond Air's LungFit PH system (XAIR)?
How much is the milestone payment Beyond Air (XAIR) will receive for CE mark approval?
When will Beyond Air (XAIR) begin commercial shipments of LungFit PH in international markets?
What are the approved dosage ranges for Beyond Air's LungFit PH system (XAIR)?
