Welcome to our dedicated page for Beyond Air news (Ticker: XAIR), a resource for investors and traders seeking the latest updates and insights on Beyond Air stock.
Beyond Air, Inc. (symbol: XAIR) is a clinical-stage medical device and biopharmaceutical company focused on revolutionizing respiratory disease treatments through innovative technology. The company's flagship product is the LungFit™ system, a Nitric Oxide (NO) Generator and Delivery System that uses NO generated from ambient air to deliver precise amounts of NO to the lungs of both ventilated and non-ventilated patients. This breakthrough technology is aimed at treating various pulmonary diseases, including pulmonary hypertension, severe lung infections such as SARS-CoV-2, and nontuberculous mycobacteria (NTM).
LungFit™ can generate up to 400 ppm of NO, offering flexibility in delivery either continuously or for a fixed period. It also features the ability to titrate the dose on demand or maintain a constant dose. This system is currently advancing in clinical trials and has garnered attention for its potential in treating lower respiratory tract infections that are not effectively addressed by current standards of care.
Beyond Air is also exploring ultra-high concentrations of NO with a proprietary delivery system separate from LungFit™ to target certain solid tumors. This preclinical testing aims to offer new hope for cancer treatments, making Beyond Air a pioneer in utilizing NO for diverse therapeutic applications.
Notably, Beyond Air has achieved significant milestones, including FDA approval for its LungFit® PH system designed for treating term and near-term neonates with hypoxic respiratory failure. The company has partnered with The Hebrew University of Jerusalem to develop treatments for neurological disorders like autism spectrum disorder (ASD). In addition, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO to target specific solid tumors.
Financially, Beyond Air has shown a commitment to growth, as evidenced by its recent increase in general and administrative expenses, primarily driven by stock-based compensation and professional fees. The company maintains a forward-looking stance, aiming to expand its product portfolio and enhance its market position.
For more detailed information on their latest developments and product offerings, visit Beyond Air's official website.
Beyond Air, Inc. (NASDAQ: XAIR) announced that Steve Lisi, its CEO, will participate in the 32nd Annual Piper Sandler Healthcare Conference virtually from December 1-3, 2020. The company will provide a pre-recorded investor presentation and engage in virtual one-on-one meetings.
Beyond Air is focused on developing inhaled nitric oxide (NO) therapies for respiratory conditions, including severe infections and pulmonary hypertension. Its LungFit™ device generates NO from ambient air, potentially treating various pulmonary diseases.
Beyond Air submitted a premarket approval (PMA) to the FDA for LungFit™ PH, targeting persistent pulmonary hypertension of the newborn (PPHN). Enrollment for an acute viral pneumonia study is set to begin next week. The company reported $350,000 in revenue for Q2 2020, down from $646,000 in Q2 2019, and a net loss of $5.1 million or ($0.30) per share. Cash reserves stand at $22.4 million. Upcoming milestones include potential FDA approval for LungFit™ PH and initiation of a pilot study for nontuberculous mycobacteria lung infection.
Beyond Air, Inc. (NASDAQ: XAIR) has submitted a premarket approval (PMA) application to the FDA for its LungFit™ PH device, aimed at treating persistent pulmonary hypertension of the newborn (PPHN). The PMA review will take 180 days, with a potential launch in Q2 2021 pending approval. This device generates nitric oxide from ambient air, eliminating the need for traditional gas cylinders, thereby enhancing safety and operational efficiency in hospitals. PPHN affects approximately 1.9 per 1000 live births and can have serious health consequences for newborns.
Beyond Air, Inc. (NASDAQ: XAIR) will report its financial results for the second fiscal quarter ended September 30, 2020, on November 11, 2020, followed by a conference call at 4:30 PM ET. The company focuses on developing inhaled nitric oxide for respiratory conditions and gaseous NO for treating tumors. Its product, LungFit™, can deliver precise NO dosage continuously or at fixed intervals, with ongoing clinical trials targeting severe lung infections, including SARS-CoV-2. For more information, visit www.beyondair.net.
Beyond Air, Inc. (NASDAQ: XAIR) announced plans to initiate a clinical study to evaluate the safety and efficacy of the LungFit™ system using inhaled Nitric Oxide (NO) for hospitalized adults with acute viral pneumonia, including SARS-CoV-2 infections. The multi-center trial in Israel aims to enroll 90 patients, comparing NO treatment combined with standard supportive care against supportive care alone. The LungFit™ system generates NO from ambient air, providing potential advantages in treating respiratory conditions.
Beyond Air (NASDAQ: XAIR) announced promising preclinical data indicating that high concentrations of gaseous nitric oxide (gNO) administered directly to solid tumors may induce a systemic anti-tumor immune response. Key findings from studies on colon and breast cancer-bearing mice indicated that 100% of naïve mice had tumor uptake, whereas 27% and 0% of treated mice showed uptake, suggesting a dose-dependent effect. The company aims to further explore gNO's clinical potential, with a first in human study anticipated. This innovative approach could represent a significant shift in cancer treatment.
Beyond Air, Inc. (NASDAQ: XAIR) recently presented significant in vitro data at the CHEST Annual Meeting 2020, indicating that its LungFit™ system may serve as a potential treatment for human coronavirus infections. The data revealed a 96% reduction in viral infectivity and over 75% improvement in host cell viability after exposure to nitric oxide (NO) at 250 ppm. Additionally, intermittent dosing with 150-250 ppm NO showed promising results, including complete inhibition of infectivity. Beyond Air aims to advance LungFit™ for clinical trials addressing severe lung infections, including COVID-19.
Beyond Air (NASDAQ: XAIR) has shared promising data on its bronchiolitis program during the CHEST Annual Meeting 2020. The pilot study, involving 87 infants, found that inhaled nitric oxide (NO) at 150 ppm significantly outperformed standard supportive therapy and 85 ppm NO in reducing hospital stay and improving oxygen saturation. All treatment groups exhibited similar safety profiles, with no serious drug-related adverse events reported. CEO Steve Lisi expressed optimism about advancing the LungFit™ system towards a definitive study, underscoring the potential of NO as a therapeutic agent for respiratory infections.
Beyond Air, Inc. (NASDAQ: XAIR) announced promising preclinical data suggesting that its gaseous nitric oxide (gNO) treatment can effectively target lung cancer. In in vitro tests, gNO reduced viability of LLC1 lung cancer cells in a dose-dependent manner. Additionally, in vivo studies showed that 100% of gNO-treated mice rejected a subsequent tumor challenge, while all control mice accepted the tumor challenge. The results were presented at the IASLC North America Conference on Lung Cancer 2020, supporting gNO's potential as a treatment for both primary and metastatic lung cancer.
Beyond Air, Inc. (NASDAQ: XAIR) announced that Chairman and CEO Steven Lisi will attend the Oppenheimer & Co. Fall Healthcare Life Sciences and MedTech Summit from September 21-23, 2020. Lisi's presentation is scheduled for September 22 at 10:00 a.m. EDT, with a live webcast available via Oppenheimer.
Beyond Air specializes in developing inhaled nitric oxide therapies for respiratory conditions. Their LungFit™ system generates nitric oxide from ambient air for treating various pulmonary diseases, with ongoing clinical trials targeting severe lung infections.
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