Latest news with #LungFitPH
Yahoo
10 hours ago
- Health
- Yahoo
Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH
LungFit PH II's smaller, lightweight, transport-ready design is expected to open the entirety of the NO market Final design based upon substantial feedback from respiratory therapists across the countryGARDEN CITY, N.Y., June 16, 2025 (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 the submission of a premarket approval (PMA) supplement application to the U.S. Food and Drug Administration (FDA) for LungFit PH II, the next-generation therapeutic nitric oxide generator. Beyond Air has developed its LungFit PH II system to be smaller, lighter and fully transport-ready — while delivering all the breakthrough features of the currently FDA-approved version from the Company's therapeutic platform of nitric oxide generators targeting pulmonary disease. The new system uses the same Smart Filter and accessories as the first-generation device, ensuring continuity, streamlined logistics, and minimal disruption for existing customers. The LungFit PH platform uses the Company's patented Ionizer™ technology to generate unlimited on-demand nitric oxide from ambient air, which is then able to be delivered directly to a ventilator circuit, regardless of dose or flow. The LungFit PH system uses the equivalent power of a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, forming nitric oxide with low levels of nitrogen dioxide (NO2) created as a byproduct. The gas then passes through a Smart Filter, which removes the toxic NO2 from the internal circuit. For the treatment of PPHN, the novel LungFit PH system is designed to deliver NO doses 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 provides 12 hours of therapy regardless of ventilator demands and can be replaced in seconds for uninterrupted treatment. 'We are pleased to announce that development of our transport-ready LungFit PH II has resulted in a NO system which we believe is far superior to legacy systems currently available in the market. While our first-generation system already delivers key advantages to hospitals, this next-generation device raises the bar with a reduced weight and footprint, simplified operation, longer service interval, and full compatibility with both air and ground transport. It also includes an automated backup system that retains most primary system capabilities,' said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. 'Once approved, we are confident that the introduction of LungFit PH II will play a pivotal role in accelerating our market expansion and advancing our position as a global leader in hospital-based NO delivery.' NO gas is a vasodilator approved in dozens of countries to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. Low concentration inhaled NO therapy has been the standard-of-care for PPHN for over 20 years in the United States. PPHN is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4-6.8/1,000 live births) with a mortality rate ranging between 4-33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. In the European Union and many other countries outside the United States, NO is also approved 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. About LungFit *Beyond Air's LungFit is a cylinder-free, phasic flow generator and delivery system 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 by eliminating NO2 purging steps, and offering other operational 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, European Union, Australia, Thailand and New Zealand. 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 PPHNPersistent pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. About Beyond Air®, 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. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM). The Company has also 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 Forward Looking StatementsThis press release contains 'forward-looking statements' concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. 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 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 and Beyond Cancer undertake 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, Advisors, LLCCdavis@ 915-2577 A photo accompanying this announcement is available at
Yahoo
a day ago
- Health
- Yahoo
Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH
LungFit PH II's smaller, lightweight, transport-ready design is expected to open the entirety of the NO market Final design based upon substantial feedback from respiratory therapists across the countryGARDEN CITY, N.Y., June 16, 2025 (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 the submission of a premarket approval (PMA) supplement application to the U.S. Food and Drug Administration (FDA) for LungFit PH II, the next-generation therapeutic nitric oxide generator. Beyond Air has developed its LungFit PH II system to be smaller, lighter and fully transport-ready — while delivering all the breakthrough features of the currently FDA-approved version from the Company's therapeutic platform of nitric oxide generators targeting pulmonary disease. The new system uses the same Smart Filter and accessories as the first-generation device, ensuring continuity, streamlined logistics, and minimal disruption for existing customers. The LungFit PH platform uses the Company's patented Ionizer™ technology to generate unlimited on-demand nitric oxide from ambient air, which is then able to be delivered directly to a ventilator circuit, regardless of dose or flow. The LungFit PH system uses the equivalent power of a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, forming nitric oxide with low levels of nitrogen dioxide (NO2) created as a byproduct. The gas then passes through a Smart Filter, which removes the toxic NO2 from the internal circuit. For the treatment of PPHN, the novel LungFit PH system is designed to deliver NO doses 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 provides 12 hours of therapy regardless of ventilator demands and can be replaced in seconds for uninterrupted treatment. 'We are pleased to announce that development of our transport-ready LungFit PH II has resulted in a NO system which we believe is far superior to legacy systems currently available in the market. While our first-generation system already delivers key advantages to hospitals, this next-generation device raises the bar with a reduced weight and footprint, simplified operation, longer service interval, and full compatibility with both air and ground transport. It also includes an automated backup system that retains most primary system capabilities,' said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. 'Once approved, we are confident that the introduction of LungFit PH II will play a pivotal role in accelerating our market expansion and advancing our position as a global leader in hospital-based NO delivery.' NO gas is a vasodilator approved in dozens of countries to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. Low concentration inhaled NO therapy has been the standard-of-care for PPHN for over 20 years in the United States. PPHN is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4-6.8/1,000 live births) with a mortality rate ranging between 4-33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. In the European Union and many other countries outside the United States, NO is also approved 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. About LungFit *Beyond Air's LungFit is a cylinder-free, phasic flow generator and delivery system 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 by eliminating NO2 purging steps, and offering other operational 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, European Union, Australia, Thailand and New Zealand. 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 PPHNPersistent pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. About Beyond Air®, 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. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM). The Company has also 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 Forward Looking StatementsThis press release contains 'forward-looking statements' concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. 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 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 and Beyond Cancer undertake 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, Advisors, LLCCdavis@ 915-2577 A photo accompanying this announcement is available at in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
11-02-2025
- Business
- Yahoo
Beyond Air Inc (XAIR) Q3 2025 Earnings Call Highlights: Revenue Growth and Strategic Advances ...
Revenue: $1.1 million for the fiscal third quarter of 2025, compared to $0.4 million a year ago. Gross Profit: $0.2 million loss for the fiscal third quarter of 2025, compared to a $0.4 million loss for the same period last year. Research and Development Expenses: $3 million, down from $6.8 million for the three months ended December 31, 2023. SG&A Expenses: $7.7 million for the three months ended December 31, 2024, compared to $9.8 million in the previous year. Net Loss: $13 million or a loss of $0.15 per share basic and diluted, compared to $16.2 million or a loss of $0.50 per share basic and diluted for the same period last year. Net Cash Burn: $7.6 million for the quarter, more than 30% lower than the prior quarter ended September 30, 2024. Cash, Cash Equivalents, and Marketable Securities: $10.9 million as of December 31, 2024. Warning! GuruFocus has detected 4 Warning Signs with XAIR. Release Date: February 10, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Beyond Air Inc (NASDAQ:XAIR) reported sequential quarterly revenue growth driven by new hospital signings and contract renewals for their LungFit PH system. The company received CE Mark approval for LungFit PH, allowing marketing in the European Union and other countries, triggering a $1 million milestone payment. Beyond Air Inc (NASDAQ:XAIR) has strengthened customer engagement and partnerships, enhancing their sales and distribution capabilities globally. The company is making progress in its Beyond Cancer initiative, with a Phase Ib trial for nitric oxide therapy in late-stage cancer patients underway. Cost reductions have led to a significant decrease in net cash burn, with expectations for continued lower cash burn in the upcoming quarters. Despite revenue growth, Beyond Air Inc (NASDAQ:XAIR) reported a $0.2 million loss in gross profit for the fiscal third quarter of 2025. The company faces uncertainties with FDA approval timelines for their PMA supplement and next-generation LungFit PH system. Research and development expenses remain high, although they have decreased compared to the previous year. The company has a net loss of $13 million for the quarter, although this is an improvement from the previous year's loss. There is uncertainty regarding the timing and impact of international sales, with potential delays in regulatory processes outside the U.S. Q: How will the CE Mark approval impact Beyond Air's revenues, and what is the expected timeline for this impact? A: Steven Lisi, CEO, explained that the impact of the CE Mark approval on revenues will not be immediate. He anticipates a small impact in the June quarter, with more significant contributions expected in the September and December quarters as shipments begin in the first half of the calendar year. Q: Can you provide insights into the expected trend of operating expenses, particularly in relation to R&D and other expenses? A: Steven Lisi, CEO, noted that operating expenses, excluding R&D, are expected to decrease incrementally in the next quarter. However, R&D expenses may increase due to the PMA submission for the next-generation LungFit PH. Q: What changes have been made to the commercial organization that are driving sequential growth? A: Steven Lisi, CEO, attributed the growth to a cultural shift led by the new Chief Commercial Officer, David. The company has improved customer service and created a more positive internal culture, which has enhanced customer engagement and satisfaction. Q: How significant is the transport PMA submission, and is there a pipeline of customers waiting for approval? A: Steven Lisi, CEO, indicated that the next-generation product, which is transport capable and has other upgrades, is highly anticipated by customers. While there is no formal waiting list, there is significant interest and demand for the product. Q: What is the long-term outlook for the U.S. versus international markets for LungFit PH? A: Steven Lisi, CEO, projected that in five years, the international market will be larger than the U.S. market due to the unique advantages of LungFit PH, such as generating nitric oxide from ambient air, which addresses logistical challenges in many countries. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
