Persistent Fetal Circulation Syndrome

Revolutionary inhaled nitric oxide technology set to reach broader healthcare systemsGARDEN CITY, N.Y., Oct. 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 endogenous and exogenous nitric oxide (NO) to improve the lives of patients, today announced entering a strategic partnership with Healthcare Links, a renowned healthcare advisory and contracting firm. This partnership is focused on expanding access to Beyond Air's LungFit® PH system by streamlining entry into Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs) across the United States. Ken Murawski, President and Founder of Healthcare Links, commented, "We are thrilled to work with Beyond Air in introducing the LungFit PH system to our extensive network of progressive GPOs and IDNs. This technology not only enhances patient care but also significantly improves logistical efficiency for healthcare providers. It’s a game-changer, and we are eager to support its expansion across the healthcare continuum." The LungFit® PH system, a groundbreaking inhaled nitric oxide (NO) generator and delivery system, has been developed to treat patients with persistent pulmonary hypertension of the newborn (PPHN) and other associated respiratory conditions. The innovative technology allows for on-demand NO generation from ambient air, eliminating the need for cylinder storage, enhancing patient safety, and improving operational efficiencies for healthcare facilities. With Healthcare Links’ expertise in facilitating relationships and contracts with GPOs and IDNs, this partnership will help fast-track the availability of LungFit PH to a larger network of hospitals and healthcare providers. By tapping into these critical distribution channels, Beyond Air aims to broaden the reach of its life-saving technology, ensuring that more patients, particularly vulnerable newborns, can benefit from this cutting-edge respiratory therapy. "Our partnership with Healthcare Links marks a pivotal moment in our mission to make the LungFit PH system widely accessible to hospitals. We are confident that by leveraging Healthcare Links’ extensive knowledge of GPOs and IDNs, we will be able to more rapidly scale access for hospitals to our innovative NO delivery technology, addressing a critical need in respiratory care,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. The LungFit® PH system is approved for commercial use in the U.S. to treat term and near-term neonates with hypoxic respiratory failure. Through this partnership, Beyond Air and Healthcare Links are committed to reducing barriers to entry and simplifying the contracting process, ensuring that hospitals across the country can seamlessly integrate this advanced respiratory therapy into their patient care protocols. As Beyond Air continues to innovate in the field of respiratory medicine, this collaboration represents a significant step in the company’s mission to deliver life-saving solutions to those who need them most. 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 only in the United States of America to treat term and near-term neonates with hypoxic respiratory failure. 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. About Beyond Air, Inc. Beyond Air, Inc. (NASDAQ: XAIR) is a global leader in medical technology focused on developing transformative treatments for lung diseases. The company’s LungFit® platform is a revolutionary NO generation and delivery system aimed at treating a variety of respiratory conditions, from neonatal intensive care needs to adult respiratory distress. Beyond Air’s innovative, portable systems are designed to eliminate the need for NO storage and transportation, improving both patient safety and healthcare efficiency. About Healthcare Links Healthcare Links is a leading advisory and contracting firm that specializes in accelerating market access for healthcare products and services. With a vast network of GPOs, IDNs, and other healthcare purchasing entities, Healthcare Links provides manufacturers with critical insights and pathways to streamline market entry and enhance product distribution across the U.S. healthcare landscape. For more information, please visit www.beyondair.net and www.healthcarelinks.net. 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 contactsCorey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.com P: (212) 915-2577

GARDEN CITY, N.Y., Sept. 27, 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, is proud to announce the deployment of its groundbreaking LungFit® PH system to the U.S. Naval Hospital Guam. This partnership, made possible through collaboration with TrillaMed, marks a significant advancement in the neonatal critical care unit, offering enhanced care for newborns in need of respiratory support. The LungFit® PH system is an innovative device designed to generate Nitric Oxide (NO) from room air and deliver NO for the treatment of persistent pulmonary hypertension in neonates (PPHN), a condition that affects the lungs and heart of newborns. The system provides a safe, efficient, and user-friendly solution to address critical respiratory conditions, ensuring that the hospital’s youngest and most vulnerable patients receive the highest standard of care. Key Features of the LungFit® PH System: Portable and compact design, making it ideal for intensive care settingsAdvanced nitric oxide generating technology with no need for high-pressure cylindersRapid response for improved oxygenation in neonates with PPHNEasy integration into existing hospital infrastructure "We are honored to support the U.S. Naval Hospital Guam in their mission to provide top-tier neonatal care," said Steve Lisi, CEO of Beyond Air. "Through our partnership with TrillaMed, we are able to extend the reach of our LungFit® PH, delivering critical solutions to the healthcare community. This collaboration is a testament to our commitment to advancing neonatal care and improving patient outcomes." The U.S. Naval Hospital Guam serves as a critical care provider for the military community in the region. More than 17,000 active-duty military personnel and family members currently are stationed on Guam, which is expected to increase by 2,500 in the next two years. The U.S. Naval Hospital Guam delivers an average of 315 babies per year, with that number expected to rise to 487 births by 2033. The introduction of the LungFit® PH system underscores the hospital's dedication to utilizing state-of-the-art technologies in neonatal care, ensuring military families have access to the latest in respiratory treatment options. 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 for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. 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 only in the United States of America to treat term and near-term neonates with hypoxic respiratory failure. 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. About TrillaMed.TrillaMed is a premier provider of medical supplies and technologies to government and healthcare systems globally. As a trusted partner, TrillaMed delivers best-in-class solutions to meet the critical needs of healthcare providers, ensuring military personnel and their families receive the highest level of care. CONTACTS: Investor Relations contacts Corey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.com (212) 915-2577

Research has implications for more common pulmonary disorders PHOENIX, June 19, 2024 /PRNewswire/ -- According to a study published in Nature Communications, research conducted at the Phoenix Children's Research Institute at the University of Arizona College of Medicine — Phoenix, shows how frequent non-coding FOXF1 gene deletions that interfere with important DNA regulatory regions, called enhancers, can lead to Alveolar Capillary Dysplasia with Misalignment of Pulmonary Veins (ACDMPV), a rare, lethal, genetic lung disease which causes respiratory failure in newborns and infants. Continue Reading Vlad Kalinichenko, MD, PhD, internationally renowned lung development and regeneration researcher and director of the Phoenix Children’s Research Institute at the University of Arizona College of Medicine – Phoenix The FOXF1 protein is critically important in pulmonary vascular development, specifically responsible for the extension and branching of airways and blood vessels in the developing lung. "Prior to this study, we knew deletions and mutations in the FOXF1 gene locus can result in ACDMPV, so our goal was to identify FOXF1 enhancers associated with the disease so we can diagnose it more precisely in newborn babies," said Vlad Kalinichenko, MD, PhD, internationally renowned lung development and regeneration researcher and director of the Phoenix Children's Research Institute at the University of Arizona College of Medicine – Phoenix. This study, conducted in collaboration with Cincinnati Children's Hospital Medical Center, identified four upstream enhancers in the FOXF1 gene locus — FOXF1 Expression in the Lung 1, 2, 3 and 4. It further showed these elements stimulate cell-specific FOXF1 expression in pulmonary endothelium and stromal cells, such as fibroblasts and pericytes. Pulmonary endothelial cells are essential to the development of alveoli, the tiny branches of air tubes in the lungs responsible for the exchange of oxygen and carbon dioxide in the bloodstream. Likewise, pulmonary stromal cells are also important to lung development and are a crucial component of overall lung structure. Since many non-coding deletions in or near the FOXF1 gene locus cause ACDMPV, identifying specific pathogenic FOXF1 enhancers — that are critical for lung development — is important to understand and diagnose ACDMPV. This work could also enable better genetic screening for the disease, which currently relies primarily on exome DNA sequencing. "This study demonstrates four specific FOXF1 enhancers play critical roles in the development of ACDMPV and resolves an important clinical question regarding why frequent non-coding FOXF1 deletions that interfere with endothelial and mesenchymal enhancers can lead to this lethal disease," said Dr. Kalinichenko. "Identifying mutations in the FOXF1 gene locus sooner will be critical for accurate genetic diagnosis of this severe congenital disease. As we continue to gain additional insight into how genes work, it will improve our capabilities to implement effective therapeutic interventions in more common pulmonary disorders of newborns and infants, such as bronchopulmonary dysplasia and congenital diaphragmatic hernia." The Phoenix Children's Research Institute at the University of Arizona College of Medicine –Phoenix launched in May 2023, formalizing a longstanding research collaboration between the health system and the University of Arizona College of Medicine – Phoenix. The Research Institute includes more than 700 active studies, 640 research investigators and 90 research staff members, including research scientists, associates, biostatisticians, pharmacists, nurses and coordinators. Scientists engage in research across multiple clinical disciplines, including cancer, neurology, cardiology, pulmonology and more. About Phoenix Children's Phoenix Children's is one of the nation's largest pediatric health systems. It comprises Phoenix Children's Hospital – Thomas Campus, Phoenix Children's Hospital – East Valley Campus, Phoenix Children's – Avondale Campus, Phoenix Children's – Arrowhead Campus, four pediatric specialty and urgent care centers, 12 community pediatric practices, 20 outpatient clinics, two ambulatory surgery centers and seven community-service outpatient clinics throughout the state of Arizona. The system provides world-class inpatient, outpatient, trauma, emergency and urgent care, and has been serving children and families for 40 years. Phoenix Children's Care Network includes more than 1,175 pediatric primary care providers and specialists who deliver care across more than 75 subspecialties. Alongside our colleagues, collaborators and communities, we're elevating pediatric care, education and innovation, so we can all grow healthier together. For more information, visit phoenixchildrens.org. SOURCE Phoenix Children's