Beyond Air Granted U.S. Patent Covering Treatment of NTM Infections Using gaseous Nitric Oxide (gNO)
Beyond Air (NASDAQ: XAIR) has secured U.S. Patent No. 12,274,830 from the USPTO for its method of treating non-tuberculous mycobacteria (NTM) lung infections using gaseous nitric oxide (gNO). The patent covers a specific dosing regimen of 200-320 ppm gNO for 10-45 minutes, 2-5 times daily, delivering 300-900 ppm-hrs of gNO per day over at least 14 days. The patent protection extends until March 12, 2038.
The company recently reported positive clinical data in the American Thoracic Society Journal demonstrating LungFit GO's potential for safe and effective at-home treatment of NTM infections. NTM is a rare but serious bacterial lung infection affecting approximately 13% of U.S. cystic fibrosis patients as of 2017. Current treatments involve lengthy antibiotic combinations with poor efficacy and potential severe side effects.
Beyond Air (NASDAQ: XAIR) ha ottenuto il brevetto statunitense n. 12.274.830 dall'USPTO per il suo metodo di trattamento delle infezioni polmonari da micobatteri non tubercolari (NTM) mediante ossido nitrico gassoso (gNO). Il brevetto riguarda un regime posologico specifico di 200-320 ppm di gNO per 10-45 minuti, da 2 a 5 volte al giorno, erogando 300-900 ppm-ore di gNO al giorno per almeno 14 giorni. La protezione brevettuale è valida fino al 12 marzo 2038.
L'azienda ha recentemente pubblicato dati clinici positivi sul American Thoracic Society Journal che dimostrano il potenziale di LungFit GO come trattamento sicuro ed efficace per le infezioni da NTM da effettuare comodamente a casa. L'NTM è un'infezione batterica polmonare rara ma grave che colpisce circa il 13% dei pazienti statunitensi con fibrosi cistica nel 2017. I trattamenti attuali prevedono lunghe terapie antibiotiche con scarsa efficacia e possibili effetti collaterali gravi.
Beyond Air (NASDAQ: XAIR) ha obtenido la patente estadounidense No. 12,274,830 de la USPTO para su método de tratamiento de infecciones pulmonares por micobacterias no tuberculosas (NTM) utilizando óxido nítrico gaseoso (gNO). La patente cubre un régimen de dosificación específico de 200-320 ppm de gNO durante 10-45 minutos, de 2 a 5 veces al día, administrando 300-900 ppm-horas de gNO por día durante al menos 14 días. La protección de la patente se extiende hasta el 12 de marzo de 2038.
La compañía informó recientemente datos clínicos positivos en la revista American Thoracic Society Journal que demuestran el potencial de LungFit GO para un tratamiento seguro y efectivo en casa de las infecciones por NTM. La NTM es una infección bacteriana pulmonar rara pero grave que afecta aproximadamente al 13% de los pacientes con fibrosis quística en EE.UU. en 2017. Los tratamientos actuales implican combinaciones prolongadas de antibióticos con baja eficacia y posibles efectos secundarios graves.
Beyond Air (NASDAQ: XAIR)는 USPTO로부터 비결핵 미코박테리아(NTM) 폐 감염 치료를 위한 가스 상태의 일산화질소(gNO) 사용 방법에 대해 미국 특허 번호 12,274,830을 취득했습니다. 이 특허는 하루에 2~5회, 10~45분 동안 200-320 ppm의 gNO를 투여하며, 최소 14일 동안 하루 300-900 ppm-시간의 gNO를 제공하는 특정 투여 요법을 포함합니다. 특허 보호 기간은 2038년 3월 12일까지입니다.
회사는 최근 American Thoracic Society Journal에 LungFit GO가 NTM 감염을 안전하고 효과적으로 가정에서 치료할 수 있는 잠재력을 보여주는 긍정적인 임상 데이터를 발표했습니다. NTM은 드물지만 심각한 세균성 폐 감염으로, 2017년 기준 미국 낭포성 섬유증 환자의 약 13%가 영향을 받았습니다. 현재 치료법은 효과가 낮고 심각한 부작용이 있을 수 있는 장기간 항생제 복합 요법을 포함합니다.
Beyond Air (NASDAQ : XAIR) a obtenu le brevet américain n° 12 274 830 de l’USPTO pour sa méthode de traitement des infections pulmonaires à mycobactéries non tuberculeuses (NTM) utilisant du monoxyde d’azote gazeux (gNO). Le brevet couvre un schéma posologique spécifique de 200-320 ppm de gNO pendant 10 à 45 minutes, 2 à 5 fois par jour, délivrant 300 à 900 ppm-heures de gNO par jour sur au moins 14 jours. La protection par brevet est valable jusqu’au 12 mars 2038.
L’entreprise a récemment publié des données cliniques positives dans le American Thoracic Society Journal démontrant le potentiel de LungFit GO pour un traitement sûr et efficace des infections à NTM à domicile. La NTM est une infection bactérienne pulmonaire rare mais grave qui touche environ 13 % des patients américains atteints de fibrose kystique en 2017. Les traitements actuels reposent sur des combinaisons d’antibiotiques longues, peu efficaces et pouvant entraîner des effets secondaires graves.
Beyond Air (NASDAQ: XAIR) hat vom USPTO das US-Patent Nr. 12.274.830 für sein Verfahren zur Behandlung von Lungenerkrankungen durch nicht-tuberkulöse Mykobakterien (NTM) mit gasförmigem Stickstoffmonoxid (gNO) erhalten. Das Patent umfasst ein spezielles Dosierungsschema von 200-320 ppm gNO für 10-45 Minuten, 2-5 Mal täglich, mit einer täglichen Gesamtmenge von 300-900 ppm-Stunden gNO über mindestens 14 Tage. Der Patentschutz gilt bis zum 12. März 2038.
Das Unternehmen veröffentlichte kürzlich positive klinische Daten im American Thoracic Society Journal, die das Potenzial von LungFit GO für eine sichere und wirksame Behandlung von NTM-Infektionen zu Hause belegen. NTM ist eine seltene, aber schwere bakterielle Lungenerkrankung, die etwa 13 % der US-amerikanischen Mukoviszidose-Patienten im Jahr 2017 betrifft. Die aktuellen Behandlungen bestehen aus langwierigen Antibiotikakombinationen mit geringer Wirksamkeit und möglichen schweren Nebenwirkungen.
- Secured new patent protection until 2038 for NTM treatment method
- Recent positive clinical data published in American Thoracic Society Journal
- Innovative at-home self-administration capability with LungFit GO
- None.
Insights
Beyond Air's new patent strengthens their competitive position in NTM treatment through 2038, creating valuable IP barriers against competitors.
The USPTO's issuance of Patent No. 12,274,830 represents a significant intellectual property milestone for Beyond Air's NTM infection treatment program. This patent specifically protects their novel dosing regimen of gaseous nitric oxide (gNO) at concentrations between 200-320 ppm for specified durations and frequencies, creating a substantial barrier to competition until March 2038.
The extended protection timeline is particularly valuable for specialty treatments like this, as respiratory therapies typically require substantial development time before generating revenue. The specific dosing claims (300-900 ppm-hrs daily over 14+ days) suggest Beyond Air has already optimized their therapeutic approach through careful research.
For context, NTM infections represent a challenging treatment area with growing incidence due to antibiotic resistance. Current treatments require lengthy, multi-drug regimens with poor efficacy against certain strains like Mycobacterium abscessus complex.
This patent strengthens Beyond Air's commercial positioning in two key ways: it extends protection for their core LungFit technology platform, and it specifically covers home-based administration, potentially creating a significant advantage over hospital-based therapies. For a company with Beyond Air's market capitalization, expanding patent protection for core innovations is essential for long-term value creation.
New patent for home-based nitric oxide therapy offers potential breakthrough for difficult-to-treat NTM infections resistant to conventional antibiotics.
This patent strengthens Beyond Air's position in addressing non-tuberculous mycobacteria (NTM) lung infections, a serious condition with significant treatment challenges. NTM infections represent a growing problem in respiratory medicine due to increasing antibiotic resistance and the limitations of current therapies.
Current treatment protocols are problematic: they require combinations of multiple antibiotics administered for up to two years, often with significant toxicity and still yielding poor outcomes for certain strains like MABSC. The potential for a non-antibiotic approach using gaseous nitric oxide represents a mechanistically distinct alternative.
What's particularly notable is the possibility of home-based self-administration mentioned in their clinical data. This would represent a dramatic improvement over current regimens that often require prolonged medical supervision and can severely impact quality of life.
The specific dosing regimen protected by this patent (200-320 ppm for 10-45 minutes, 2-5 times daily) suggests Beyond Air has identified an effective therapeutic window. For vulnerable populations like cystic fibrosis patients, where NTM prevalence reached 13% in 2017, new treatment options are urgently needed.
While early positive clinical data is encouraging, the ultimate value will depend on comprehensive efficacy and safety outcomes through completed trials and regulatory review. Nevertheless, this represents a potentially important advancement for a patient population with treatment options.
GARDEN CITY, N.Y., April 24, 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 that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,274,830. The issued patent gives the Company protection for its method of delivering gaseous nitric oxide (gNO) to a patient that has a condition associated with non-tuberculous mycobacteria (NTM) lung infection.
“This latest patent further strengthens our growing intellectual property portfolio and reinforces the potential of our LungFit program,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We recently announced the publication of positive clinical data in the American Thoracic Society Journal showing the potential LungFit GO has in safe and effective treatment of NTM lung infections with patients self-administering NO at home.”
The allowed claims in this patent encompass a novel dosing regimen of 200 ppm to 320 ppm gNO for 10 to 45 minutes, 2 to 5 times per day, to provide a nitric oxide-load (NO load) of 300 ppm-hrs to 900 ppm-hrs of gNO per day over a period of at least 14 days. The patent will expire on March 12, 2038.
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,
About Beyond Air®, Inc.
Beyond Air is a commercial-stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval and CE Mark for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. 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 www.beyondair.net.
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 Nitric Oxide
Nitric Oxide (NO) 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-cardiac surgery, and persistent pulmonary hypertension of the newborn to treat hypoxemia.
Additionally, NO is believed to play a key role in the innate immune system, and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria—including both gram-positive and gram-negative—but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast, and parasites, and has the potential to eliminate multi-drug-resistant strains.
Forward Looking Statements
This press release contains “forward-looking statements” 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 contacts
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
FAQ
What is the new patent granted to Beyond Air (XAIR) for NTM treatment?
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