Provides fiscal year 2025 revenue guidance of $12 - $16 million
US pilot trial of LungFit® PRO to treat viral community acquired pneumonia (VCAP) underway with data expected mid-calendar 2024
Beyond Cancer presents positive first-in-human data for intratumoral administration of ultra-high concentration nitric oxide (UNO) therapy demonstrating safety and evidence of immune system activation at the Society for Immunotherapy Conference (SITC)
Submitted PMA supplement to FDA for the expansion of LungFit PH label to include cardiac surgery; approval anticipated in second half calendar 2024
LungFit PH granted Innovative Technology contract from  Vizient, Inc. , the nation’s largest provider-driven health care performance improvement company
Entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region
Conference call scheduled for 4:30 p.m. ET today, November 13th
GARDEN CITY, N.Y., Nov.  13, 2023  (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 suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced its financial results for the fiscal quarter ended September 30, 2023. “The Beyond Air and Beyond Cancer teams continue to execute. In the last three months, we have made significant strides in the US hospital market with LungFit PH, licensed LungFit PH in certain Asian markets, submitted a PMA supplement to the FDA for cardiac surgery, presented preclinical and human data for treatment of solid tumors with UNO and began the United States VCAP study,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Market confidence in our superior LungFit PH technology continues to grow along with our market penetration and opportunities. I am proud of our progress and want to thank our customers who gave us the opportunity to succeed over the past year. At the American Academy of Respiratory Care (AARC) last week there was great enthusiasm around our enhanced LungFit PH system which gives us confidence in our fiscal 2025 revenue guidance as well as our belief that LungFit PH will become the dominant product in the market”. Recent Highlights and Upcoming Milestones
LungFit® PH
Provided revenue guidance of $12 - $16 million for the fiscal year ending March 31, 2025
Entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region, paving the way for an ex-U.S. launch
Received an Innovative Technology contract from  Vizient Inc. based on recommendations by hospital experts who serve on Vizient’s customer-led councils
CE Mark anticipated to be received in first half calendar 2024
Submitted a PMA supplement to the FDA for a cardiac surgery label expansion; approval anticipated in calendar year 2024
LungFit® PRO
Initiated the process for opening sites for a U.S. pilot trial for patients hospitalized with viral community-acquired pneumonia (VCAP)
Randomized, double-blind, placebo-controlled trial in 50 patients at 10 sites
Top line data expected mid-year 2024 from VCAP study
LungFit® GO
Plan to initiate a U.S. trial for patients with nontuberculous mycobacteria (NTM) in calendar year 2025, pending discussion with the FDA
COPD pilot trial on hold due to strategic prioritization
Beyond Cancer - Solid Tumor Program
First-in-human data presented at the Society for Immunotherapy Conference (SITC) in November 2023 show that a single intratumoral injection of UNO therapy for 5 minutes was safe and well tolerated in patients and showed upregulation of cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells while downregulating T-regulatory cells and mononuclear-myeloid-derived suppressor cells (M-MDSC)
Published pre-clinical data demonstrating that UNO therapy combined with anti-mPD-1 has a synergistic immune response resulting in a significant improvement in tumor regression rates and survival in mice
Pooled data analysis of combination studies with 50,000 or 100,000 ppm UNO and anti-mPD-1 demonstrated more than a doubling in survival versus anti-mPD-1 alone, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Autism Spectrum Disorder (ASD) Program
Announced pre-clinical data demonstrating a therapeutic effect for at least 10 days after a single subcutaneous injection of an extended-release selective neuronal nitric oxide synthase (nNOS) inhibitor
Plan to initiate a first-in-human study for treatment of ASD in 2025
Financial Results for the Fiscal Quarter Ended September 30, 2023
Revenues for the three months ended September 30, 2023 were $0.24 million compared to zero for the quarter ended September 30, 2022. Cost of revenue of $0.4 million was recognized for the three months ended September 30, 2023, compared to $0.2 million for the three months ended September 30, 2022. Research and development expenses for the three months ended September 30, 2023 were $7.1 million as compared to $4.5 million for the three months ended September 30, 2022. The additional $2.7 million was due primarily to an increase in stock-based compensation, salaries, and development costs associated with the pipeline. General and administrative expenses for the three months ended September 30, 2023 and September 30, 2022 were $10.2 million and $8.0 million, respectively. The $2.2m increase was mainly due to stock based compensation, professional fees and salaries. Net loss attributed to common stockholders for the three months ended September 30, 2023, was ($16.2) million or a loss of ($0.51) per share, basic and diluted. The Company’s net loss attributed to common stockholders for the three months ended September 30, 2022 was ($12.0) million or a loss of ($0.40) per share, basic and diluted. Total cash burn in the quarter ended September 30, 2023, was $16.5 million, including $6.4 million in one-time payments which had previously been disclosed and accrued. Aside from these one-time payments, cash burn in the quarter was $10.1 million which is in line with our guidance of approximately $10 million per quarter. As of September 30, 2023, the Company had cash, restricted cash, cash equivalents and marketable securities of $43.9 million. Conference Call & Webcast
1-877-407-0784 (Domestic)
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. Beyond Air is currently advancing its other 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. 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 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 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 PPHN
Persistent 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 1000 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 Viral Community-Acquired Pneumonia (VCAP)
In adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year. While viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (RSV) and influenza virus, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia. Patients aged 65 years or older are at particular risk for death from the disease, as are patients with other underlying health conditions or weakened immune systems. There is no consensus regarding the use of antiviral drugs to treat viral pneumonia, and specific preventative measures are currently limited to the influenza vaccine. Given that current treatment recommendations are largely limited to supportive care, there is an unmet medical need for effective treatment options. NO may prove to be a treatment as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral replication process. About NTM
NTM infection is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with high morbidity and mortality. NTM infection is acquired by inhaling aerosolized bacteria from the environment, and can lead to NTM lung disease, a progressive and chronic condition. According to the Cystic Fibrosis Foundation, 13% of U.S. cystic fibrosis patients had a positive culture for a NTM species in 2017. NTM is considered an emerging public health concern worldwide because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics dosed chronically for as long as two years. These complex, expensive and invasive regimens have a poor record in the treatment of Mycobacterium abscessus complex (MABSC) and refractory Mycobacterium avium complex (MAC) and have the potential to cause severe adverse events. Beyond Air’s system is designed to deliver 150 – 400 ppm NO to the lungs, and early data, including from the pilot study of the LungFit GO, indicate that this range of NO concentrations could have a positive effect on patients infected with NTM. About Bronchiolitis
The majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday. While most infants with RSV present with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening. The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures. Beyond Air’s system is designed to effectively deliver 150 – 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi, and other microbes from the lungs. About Beyond Cancer, Ltd. Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing (UNO via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human study is underway in patients with solid tumors. The Company is conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols. For more information, visit www.beyondcancer.com . About UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. UNO therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. The Company believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment and with limited toxicity or off-target effects. About ASD
ASD is a serious neurodevelopmental and behavioral disorder, and one of the most disabling conditions and chronic illnesses in children. ASDs include a wide range of developmental disorders that share a core of neurobehavioral deficits manifested by abnormalities in social interactions, deficits in communication, restricted interests, and repetitive behaviors. In 2023, the CDC reported that approximately 1 in 36 children in the U.S. is diagnosed with an ASD. On average, ASD costs an estimated $60,000 a year through childhood, with the bulk of the costs in special services and lost wages related to increased demands on one or both parents. Mothers of children with ASD, who tend to serve as the child’s case manager and advocate, are less likely to work outside the home. On average, they work fewer hours per week and earn 56 percent less than mothers of children with no health limitations and 35 percent less than mothers of children with other disabilities or disorders. The cost of caring for Americans with autism reached $268 billion in 2015 and is expected to rise to $461 billion by 2025 in the absence of more-effective interventions and support across the life span. Forward Looking Statements
This 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:

Beyond Air® Reports Financial Results for Second Quarter of Fiscal Year 2024

Partnership provides access to hospitals in key Asia-Pacific countries
Getz Healthcare will make a payment to Beyond Air upon receipt of CE Mark
Beyond Air will receive royalty payments based on net sales
GARDEN CITY, New York, Sept.  07, 2023  (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 suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced that it has entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region, pending regulatory approvals. “This partnership with Getz Healthcare expands the reach of Beyond Air’s innovative technology into key growth markets outside of the United States,” stated Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We are excited to work with such a strong partner which is well positioned to maximize the potential for LungFit PH in the Asia-Pacific region.”
Under the terms of the agreement, Getz Healthcare will make a milestone payment to Beyond Air following CE mark certification of LungFit PH in the European Union. CE mark certification in Europe provides a pathway to approval in certain countries across the Asia-Pacific region. In addition, Beyond Air will receive ongoing royalty payments based on net sales of LungFit PH. The partnership provides access to hospitals in Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore and Vietnam. Getz Healthcare will manage the logistics, sales, service, and maintenance process in each of these countries where they have extensive experience with medical device distribution and hospital sales. Also, Getz Healthcare’s regulatory team will handle local product registration in addition to customer service and support. Beyond Air will provide the LungFit PH device and all accessories on a cost-plus basis, as well as providing other support services in areas such as marketing. James Simkins, CEO of Getz Healthcare, commented, “We are thrilled to announce our partnership with Beyond Air, a pivotal step forward in Getz Healthcare’s unwavering commitment to deliver impactful healthcare solutions to the Asia-Pacific region. Together, we will be pioneering innovative approaches in the delivery and access to nitric oxide therapy." BTIG, LLC acted as the financial advisor to Beyond Air, Inc.
About LungFit®PH*
Beyond Air’s LungFit PH is a cylinder-free, phasic flow generator and delivery system that has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). The device is ventilator compatible and can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. LungFit PH 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 PH is the first and only FDA approved system with patented Ionizer technology that generates nitric oxide using room air, enabling the delivery of unlimited, on-demand nitric oxide regardless of dose and flow. * Beyond Air’s LungFit PH is currently approved for commercial use only in the United States of America to treat term and near-term neonates with hypoxic respiratory failure. 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. Beyond Air is currently advancing its other 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-clinicals program dedicated to the treatment of autism spectrum disorder (ADS) and other neurological disorders. 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 Getz Healthcare
Getz Healthcare is recognized as the leading distributor of medical equipment, devices, and consumables, in Asia Pacific. The company is an ISO 9001:2015 certified company, and partners with leading manufacturers in medical technology, to offer a wide range of innovative and high-quality products and solutions, enabling customers to focus on what is important – providing better care for patients. Headquartered in Singapore, Getz Healthcare has been operating in the Asia Pacific region for over 110 years, serving over 7,500 customers, from 23 offices and distribution centers, spread across Australia, Hong Kong, Malaysia, New Zealand, Pakistan, Philippines, Taiwan, Thailand, and Vietnam. Getz Healthcare is part of The Getz Group of companies. The company’s mission is to bring meaningful healthcare solutions to the people of Asia Pacific. Forward Looking Statements
This press release contains “forward-looking statements” concerning the Company’s expectations regarding the collaboration with Getz Healthcare, the potential for LungFit PH device to be approved for commercialization in certain countries across the Asia Pacific region; and the potential safety and efficacy of the Company’s products and product candidates. 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 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 raise additional capital; 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:

Beyond Air® and Getz Healthcare Enter Strategic Collaboration to Commercialize LungFit PH in Asia-Pacific Region

Commercialize LungFit PH in Asia-Pacific Region
Partnership provides access to hospitals in key Asia-Pacific countries
Getz Healthcare will make a payment to Beyond Air upon receipt of CE Mark
Beyond Air will receive royalty payments based on net sales
Garden City, NY, September 7, 2023 - 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 suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. ("Beyond Cancer")), today announced that it has entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region, pending regulatory approvals. "This partnership with Getz Healthcare expands the reach of Beyond Air's innovative technology into key growth markets outside of the United States," stated Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We are excited to work with such a strong partner which is well positioned to maximize the potential for LungFit PH in the Asia-Pacific region." Under the terms of the agreement, Getz Healthcare will make a milestone payment to Beyond Air following CE mark certification of LungFit PH in the European Union. CE mark certification in Europe provides a pathway to approval in certain countries across the Asia-Pacific region. In addition, Beyond Air will receive ongoing royalty payments based on net sales of LungFit PH. The partnership provides access to hospitals in Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore and Vietnam. Getz Healthcare will manage the logistics, sales, service, and maintenance process in each of these countries where they have extensive experience with medical device distribution and hospital sales. Also, Getz Healthcare's regulatory team will handle local product registration in addition to customer service and support. Beyond Air will provide the LungFit PH device and all accessories on a cost-plus basis, as well as providing other support services in areas such as marketing. James Simkins, CEO of Getz Healthcare, commented, "We are thrilled to announce our partnership with Beyond Air, a pivotal step forward in Getz Healthcare's unwavering commitment to deliver impactful healthcare solutions to the Asia-Pacific region. Together, we will be pioneering innovative approaches in the delivery and access to nitric oxide therapy." BTIG, LLC acted as the financial advisor to Beyond Air, Inc.
About LungFit®PH*
Beyond Air's LungFit PH is a cylinder-free, phasic flow generator and delivery system that has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). The device is ventilator compatible and can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. LungFit PH 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 PH is the first and only FDA approved system with patented Ionizer technology that generates nitric oxide using room air, enabling the delivery of unlimited, on-demand nitric oxide regardless of dose and flow. * Beyond Air's LungFit PH is currently approved for commercial use only in the United States of America to treat term and near-term neonates with hypoxic respiratory failure. 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. Beyond Air is currently advancing its other 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-clinicals program dedicated to the treatment of autism spectrum disorder (ADS) and other neurological disorders. 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 Getz Healthcare
Getz Healthcare is recognized as the leading distributor of medical equipment, devices, and consumables, in Asia Pacific. The company is an ISO 9001:2015 certified company, and partners with leading manufacturers in medical technology, to offer a wide range of innovative and high-quality products and solutions, enabling customers to focus on what is important - providing better care for patients. Headquartered in Singapore, Getz Healthcare has been operating in the Asia Pacific region for over 110 years, serving over 7,500 customers, from 23 offices and distribution centers, spread across Australia, Hong Kong, Malaysia, New Zealand, Pakistan, Philippines, Taiwan, Thailand, and Vietnam. Getz Healthcare is part of The Getz Group of companies. The company's mission is to bring meaningful healthcare solutions to the people of Asia Pacific. 2
Forward Looking Statements
This press release contains "forward-looking statements" concerning the Company's expectations regarding the collaboration with Getz Healthcare, the potential for LungFit PH device to be approved for commercialization in certain countries across the Asia Pacific region; and the potential safety and efficacy of the Company's products and product candidates. 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 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 raise additional capital; 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:

Beyond Air : reg; and Getz Healthcare Enter Strategic Collaboration to Commercialize LungFit PH in Asia-Pacific Region - Form 8-K

Elena Nechaeva/iStock via Getty Images
Beyond Air (NASDAQ: XAIR ) said on Thursday that it had entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region. Shares of XAIR rose 1.9%. Under the deal, Getz Healthcare will make a milestone payment to Beyond Air following CE mark certification of LungFit PH in the European Union. XAIR added that it will receive ongoing royalty payments based on net sales of LungFit PH.

Beyond Air enters into strategic collaboration with Getz Healthcare

Subtle Medical’s AI-based technology now available in Australia and New Zealand through partnership with Getz Healthcare
Getz Healthcare Pty Ltd announces they have partnered with Subtle Medical —a U.S. based healthcare technology company—to distribute the Getz’s artificial intelligence (AI)-based software solutions. Subtle Medical’s software solution, SubtlePET uses proprietary deep learning algorithms to de-noise low count PET images reportedly from up to 75% lower radiotracer dose and faster scan times. According to the company, SubtleMR uses increased sharpness and de-noising to improve the image quality on up to 60% faster MRI exams. Subtle’s AI-based technology is compatible across all PET and MRI scanner brands, makes, and models. “We are thrilled to be expanding patient access to our AI solutions. Our goal is to not only make medical imaging safer and more focused on the patient, but also help imaging institutions and radiologists achieve higher quality imaging while running a more efficient operation. We are looking forward to a productive partnership with Getz,” commented Subtle Medical’s chief commercial officer, Josh Gurewitz . James Simkins, CEO, Getz Healthcare, added, “We are excited to be partnering with Subtle Medical. We believe Subtle Medical’s software solution will bring tangible benefits to our customers and ultimately patients.”
“The possibility for Subtle Medical’s software solutions to improve efficiency and image quality while extending the life of existing imaging systems is a real game changer for radiologists and patients in need of access to imaging,” commented Kimberly Hill, Managing Director of Getz Healthcare Australia and New Zealand. “We are delighted to introduce this technology to Australia and New Zealand.”
For more information, visit subtlemedical.com
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Getz Healthcare Partners with Subtle Medical

Beyond Air is a company focused on healthcare technology, specifically in the field of respiratory therapy. The company's main offering is the LungFit product line, which uses patented technology to generate on-demand nitric oxide from room air, providing a new approach to nitric oxide therapy. The primary market for Beyond Air's products is the healthcare industry, particularly hospitals and home healthcare providers. Beyond Air was formerly known as AIT Therapeutics. It was founded in 2011 and is based in Garden City, New York.

Beyond Air

`` This partnership with Getz Healthcare expands the reach of Beyond Air , Inc. 's innovative technology into key growth markets outside of the United States , '' stated Steve Lisi , Chairman and Chief Executive Officer of Beyond Air , Inc. .

Subtle Medical provides artificial intelligence (AI)-powered image enhancement. The company develops software solutions to improve image quality, reduce image noise for the entire body, including the head, spine, neck, abdomen, and musculoskeletal regions of the body, and uses denoising to improve image quality. It was founded in 2017 and is based in Menlo Park, California.

Subtle Medical

Asensus Surgical is a company that focuses on the development and manufacturing of digital laparoscopy and surgical robotics. The company's main offerings include the Senhance Surgical System and the Intelligent Surgical Unit, which are designed to enhance surgeon control, reduce surgical variability, and provide real-time insights to improve surgical outcomes. Asensus Surgical primarily serves the healthcare industry, particularly the surgical technology sector. Asensus Surgical was formerly known as TransEnterix. It was founded in 2006 and is based in Morrisville, North Carolina.

Asensus Surgical

Getz Healthcare is a distributor of medical devices and equipment.

Name	Work History	Title	Status
Boxer Cheung		Chief Financial Officer	Current
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Name	Boxer Cheung	Subscribe to see more
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Title	Chief Financial Officer	Subscribe to see more
Status	Current	Subscribe to see more

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