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Beyond Air Granted U.S. Patent Covering Treatment of NTM Infections Using gaseous Nitric Oxide (gNO)
Globenewswire· 2025-04-24 20:05
Core Insights - Beyond Air, Inc. has received U.S. Patent No. 12,274,830 for its method of delivering gaseous nitric oxide (gNO) to treat non-tuberculous mycobacteria (NTM) lung infections, enhancing its intellectual property portfolio and supporting its LungFit program [1][2] - The patent covers a dosing regimen of 200 ppm to 320 ppm gNO for 10 to 45 minutes, administered 2 to 5 times daily, providing a total NO load of 300 ppm-hrs to 900 ppm-hrs over at least 14 days, with an expiration date of March 12, 2038 [2] - NTM infections are serious and rare, leading to chronic lung disease, with 13% of U.S. cystic fibrosis patients testing positive for NTM in 2017, highlighting the need for effective treatments [3] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on using nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors, with FDA approval for its LungFit® PH system [4] - The company is advancing other LungFit systems in clinical trials for severe lung infections, including viral pneumonia and NTM [4][5] - Beyond Air has partnered with The Hebrew University of Jerusalem for a pre-clinical program targeting autism spectrum disorder and is exploring ultra-high concentrations of NO for solid tumors [5] Product Details - The LungFit® system is a cylinder-free delivery device that generates NO from ambient air, offering advantages in hospital settings by reducing inventory and improving safety [6][7] - It can deliver NO at concentrations above 80 ppm for treating severe acute lung infections in hospitals and chronic infections at home [7][8] - The LungFit PH system is approved for commercial use in multiple regions, while other systems are still investigational [8]
NeuroNOS Granted FDA Orphan Drug Designation for Phelan-McDermid Syndrome, a Neurodevelopmental Disorder Linked to Autism
Globenewswire· 2025-04-21 20:05
Core Insights - The FDA has granted Orphan Drug Designation (ODD) to NeuroNOS's lead investigational therapy, BA-102, for treating Phelan-McDermid Syndrome (PMS), a condition associated with Autism Spectrum Disorder (ASD) [1][3] - NeuroNOS plans to initiate first-in-human clinical trials for ASD in the U.S. in 2026 [1] Company Overview - NeuroNOS is a biopharmaceutical company focused on developing treatments for autism and Alzheimer disorders, and is a subsidiary of Beyond Air [1][5] - The company specializes in therapies based on small molecules that can cross the blood-brain barrier to regulate Nitric Oxide (NO) levels in the brain [5] Disease Background - Phelan-McDermid Syndrome (PMS) is a rare genetic disorder primarily caused by deletions or mutations affecting the SHANK3 gene, leading to symptoms such as global developmental delay, intellectual disability, and severe speech impairments [2][4] - There are currently no FDA-approved treatments specifically indicated for PMS [2] Development Incentives - The ODD provides several key development incentives, including seven years of market exclusivity upon approval, tax credits for qualified clinical trials, waiver of FDA application fees, and access to FDA protocol assistance [3] Commitment to Development - NeuroNOS is committed to collaborating with the FDA, patient advocacy groups, scientific foundations, and clinical investigators to accelerate the development of therapies for PMS [4]
NeuroNOS Appoints Nobel Prize Laureate, Professor Dan Shechtman, to Scientific Advisory Board
Globenewswire· 2025-04-15 20:05
Core Insights - NeuroNOS has appointed Nobel Prize laureate Professor Dan Shechtman to its Scientific Advisory Board, enhancing its scientific expertise in developing treatments for Autism Spectrum Disorder (ASD) and Alzheimer's Disease (AD) [1][2] - The company utilizes a proprietary platform that integrates advanced behavioral techniques, AI, and wet lab capabilities to accelerate treatment development for complex neurological disorders [2][5] - NeuroNOS is on track to initiate first-in-human clinical trials for ASD in the United States in 2026, marking a significant step in its mission to transform treatment for affected individuals and families [2][4] Company Overview - NeuroNOS is focused on developing innovative therapies for neurodevelopmental and neurodegenerative disorders, particularly through small molecules that regulate Nitric Oxide (NO) levels in the brain [5] - Preclinical studies indicate elevated NO levels in children with ASD and adults with brain-related diseases, suggesting that managing NO levels is crucial for normal brain function [5] - The company collaborates with leading research institutions to advance medical innovation and deliver impactful treatments [5] Scientific Advisory Board - The addition of Professor Shechtman, alongside Professor Roger Kornberg, brings unparalleled scientific expertise to NeuroNOS, significantly enhancing its research capabilities [2][4] - Professor Shechtman is recognized for his groundbreaking discovery of quasicrystals and has decades of experience in materials science and structural chemistry [3] - His involvement is expected to elevate the scientific rigor at NeuroNOS and accelerate the development of effective treatments for ASD [4]
Beyond Air Publishes Article in Annals of the American Thoracic Society Journal Highlighting NTM-PD Patients' Ability to Safely Self-Administer High-Dose Intermittent iNO Treatments Using the LungFit™ GO at Home
GlobeNewswire News Room· 2025-04-09 20:05
Core Insights - Beyond Air, Inc. announced the publication of a scientific article on the use of intermittent inhaled nitric oxide (iNO) for treating nontuberculous mycobacteria (NTM) lung infections, highlighting its potential as a novel anti-NTM agent [1][2][3] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to treat respiratory illnesses, neurological disorders, and solid tumors [7][8] - The company has received FDA approval and CE Mark for its LungFit® PH system, aimed at treating hypoxic respiratory failure in neonates, and is advancing other LungFit systems in clinical trials for severe lung infections [7][11] Clinical Study Details - The LungFit GO NTM Trial was a 12-week, multi-center, open-label clinical trial involving 15 subjects with chronic refractory NTM lung disease, supported by the U.S. Cystic Fibrosis Foundation [3][4] - Subjects were treated with high doses of iNO, starting at 150 ppm and titrated to 250 ppm, with a high treatment compliance rate of over 90% and no serious adverse events reported [4][5] Efficacy and Safety Findings - Key efficacy endpoints showed meaningful improvements in quality of life, particularly in respiratory symptoms and emotional functioning, with trends indicating a reduction in microbial load [5] - The study demonstrated a favorable safety profile, with no occurrences of methemoglobinemia and no treatment-related discontinuations [4][5] Future Directions - The results from the pilot study support the need for further evaluation of iNO as a treatment for NTM infections in larger pivotal studies [2][3]
Beyond Air Publishes Article in Annals of the American Thoracic Society Journal Highlighting NTM-PD Patients' Ability to Safely Self-Administer High-Dose Intermittent iNO Treatments Using the LungFit™ GO at Home
Newsfilter· 2025-04-09 20:05
Core Insights - Beyond Air, Inc. has published a scientific article on the use of intermittent inhaled nitric oxide (iNO) for treating nontuberculous mycobacterial (NTM) lung infections, highlighting its potential as a novel anti-NTM agent [1][2][3] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to treat respiratory illnesses, neurological disorders, and solid tumors [7][8] - The company has received FDA approval and CE Mark for its LungFit® PH system, aimed at treating hypoxic respiratory failure in neonates [7][11] Clinical Study Details - The LungFit GO NTM Trial was a 12-week, multi-center, open-label clinical trial conducted in Australia, involving 15 adult subjects with chronic refractory NTM lung disease [3][4] - The trial demonstrated high compliance (>90%) with the treatment, and no serious adverse events were reported during the 12-week treatment or follow-up periods [4][5] Efficacy and Safety Findings - Key efficacy endpoints showed meaningful improvements in quality of life, particularly in respiratory symptoms and emotional functioning [5] - Trends in the reduction of microbial load were observed, with one subject achieving culture conversion during the follow-up phase [5] Future Directions - The company plans to further evaluate the efficacy of inhaled NO in larger pivotal studies, as the pilot study results support its potential value [2][3]
NeuroNOS Announces Groundbreaking Research Publication by its CSO Demonstrating Mechanism of Action in Alzheimer’s Disease and Reinforcing Platform’s Strength Across Neurological Disorders
Globenewswire· 2025-04-01 12:00
Company Overview - NeuroNOS is a biopharmaceutical company focused on developing treatments for complex neurological disorders, including Autism Spectrum Disorder, brain cancers, and Alzheimer's disease [1][9] - The company is a subsidiary of Beyond Air (NASDAQ: XAIR) and has established a drug development platform aimed at addressing critical gaps in treatment options for neurological conditions [1][10] Recent Research and Developments - NeuroNOS announced the publication of breakthrough research by its Chief Scientific Officer, Prof. Haitham Amal, in the journal Translational Psychiatry, which presents evidence of a novel mechanism in the early stages of Alzheimer's disease [1][3] - The research identifies significant disruptions in nitric oxide (NO)-related pathways and suggests that targeted inhibition of NO production may serve as a promising therapeutic strategy for early-stage Alzheimer's disease [3][4] Market Opportunity - The global brain therapeutics market is substantial and growing, driven by an aging population and increasing prevalence of neurological disorders, with significant unmet medical needs [7] - NeuroNOS's innovative approach positions the company to capitalize on this expanding market by addressing critical treatment gaps for complex brain diseases [7] Strategic Collaborations and Intellectual Property - NeuroNOS has filed five patent families to protect its novel approach and is collaborating with leading international partners for the production of active pharmaceutical ingredients and advanced formulations [4][5] - The company's scientific team includes experts from top hospitals and institutions, including the Hebrew University of Jerusalem, which plays a central role in its research and development efforts [6][10] Clinical Development Plans - NeuroNOS is preparing for clinical trials, with plans to initiate first-in-human trials for autism in the United States in 2026 [4][8] - The company has previously achieved preclinical breakthroughs in autism and glioblastoma models, reinforcing the versatility of its nitric oxide modulation platform [8]
Beyond Air Announces Vanderbilt University Medical Center as First Luminary Site
Globenewswire· 2025-03-31 12:00
Core Insights - Beyond Air, Inc. has established Vanderbilt University Medical Center (VUMC) as its first luminary site to evaluate and promote the clinical and operational benefits of its LungFit® PH device, which utilizes tankless nitric oxide (iNO) technology [1][3] - The collaboration aims to enhance hospital-based nitric oxide therapy and optimize LungFit products through VUMC's advanced research and clinical excellence [2] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on using nitric oxide to improve patient outcomes in respiratory illnesses, neurological disorders, and solid tumors [5] - The company has received FDA approval and CE Mark for its LungFit PH system, which is designed for treating term and near-term neonates with hypoxic respiratory failure [5] Product Details - LungFit PH generates nitric oxide from room air, eliminating the need for traditional high-pressure cylinders, thus streamlining operations and enhancing efficiency in hospital settings [3][7] - The device can deliver nitric oxide at concentrations ranging from 1 ppm to 80 ppm, with potential applications in treating severe acute lung infections and chronic lung infections [7][8] Strategic Importance - The partnership with VUMC is seen as a significant step for Beyond Air, allowing the company to demonstrate the full utility of its technology to healthcare professionals and potential customers [3] - VUMC's commitment to medical innovation positions it as an ideal partner for Beyond Air in advancing iNO technology and delivery systems [3]
Beyond Oil Announces Start of Commercialization of India Distribution Agreement; First Payment Received
GlobeNewswire News Room· 2025-03-24 20:30
Core Insights - Beyond Oil Ltd. has successfully completed its first order under a five-year distribution agreement with Deep Frying Solutions Pvt Ltd for the Indian market, receiving full payment for an initial shipment of 6 tonnes [1][2][3] - The total estimated contract value for the five-year agreement is approximately $9.58 million USD, which includes the purchase of around 57 containers [2] Company Overview - Beyond Oil Ltd. is a food-tech innovation company focused on reducing health risks associated with fried food, improving sustainability, and lowering operational costs [4] - The company's patented technology significantly reduces harmful compounds in frying oil, addressing health concerns linked to the reuse of frying oil in various food service settings [4] - Beyond Oil's solutions are backed by extensive research highlighting their effectiveness in mitigating health risks, including links to cancer and cardiovascular diseases, while also improving food quality and reducing environmental impact [4]
NeuroNOS Secures $2.0 Million in Funding to Advance Development of an Innovative Autism Therapy
Globenewswire· 2025-03-24 20:05
Company Overview - NeuroNOS is a biopharmaceutical company focused on developing treatments for Autism Spectrum Disorder (ASD) and other neurological conditions, including Alzheimer's disease and brain cancers [2][9] - The company has secured an initial $2 million in equity financing to accelerate the preclinical development of its small-molecule drug designed for children with autism [2][3] Drug Development - The drug under development aims to regulate nitric oxide (NO) levels in the brain, which has shown promise in improving neurological function [2][3][9] - NeuroNOS is currently in advanced stages of formulation development, focusing on a subcutaneous injection with plans for an oral formulation to enhance accessibility for pediatric patients [6][9] Research and Scientific Basis - The research supporting NeuroNOS's drug is based on findings from Prof. Haitham Amal, indicating that children with ASD exhibit elevated NO levels, and inhibiting NO production can reverse autism-like phenotypes in models [3][4] - The partnership with the Hebrew University has validated these findings in over 700 animals and human stem cell-derived neurons, providing biological evidence of NO dysregulation's role in ASD [4][8] Market Context - Autism Spectrum Disorder is a complex neurodevelopmental condition affecting millions globally, with rising prevalence rates intensifying the need for effective treatments [7][8] - Currently, there are no FDA-approved drugs targeting the biological mechanisms underlying ASD, highlighting a critical gap that NeuroNOS aims to address [8]
Beyond Oil Announces First Distribution Agreement in Portugal
GlobeNewswire News Room· 2025-03-19 20:30
VANCOUVER, BC and KIBBUTZ YIFAT, Israel, March 19, 2025 (GLOBE NEWSWIRE) -- Beyond Oil Ltd. (CSE: BOIL) (OTCQB: BEOLF) (Frankfurt: UH9) (“Beyond Oil” or the “Company”), a food-tech innovation company dedicated to reducing health risks associated with fried food while lowering operational costs, minimizing waste, and enhancing sustainability, is pleased to announce that it has signed its first distribution agreement (the “Agreement”) in Portugal with Serious Formula Ltd (“Serious Formula” or the “Distributor ...