Evaluation and Management of Pulmonary Hypertension in Noncardiac Surgery: A Scientific Statement From the American Heart Association
Vasodilators May Improve Outcomes In Persistent Pulmonary Hypertension In Newborns
Various pulmonary vasodilators may improve outcomes in persistent pulmonary hypertension (PPH) in newborns, according to study results submitted to the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024, held virtually from September 27 to 30, 2024.
Inhaled nitric oxide is considered the primary treatment for PPH in newborns, which is associated with a significant increase in neonatal mortality and morbidity. Investigators compared the efficacy of various vasodilators as adjunctive therapy or as second-line therapy for management of PPH in newborns.
The investigators conducted a systematic review and network meta-analysis pooling results of 12 randomized controlled trials (RCTs; N=2911 patients) to analyze multiple treatment options including endothelin-1 receptor antagonists, phosphodiesterase inhibitors, and inhaled nitric oxide.
In the treatment group, compared with placebo, sildenafil and milrinone showed statistically significant reductions in hospital length of stay (mean difference [MD], -6.6 days [95% CI, -12.68 to -0.60] and MD, -6.9 [95% CI, -12.36 to -1.36], respectively).
Reducing treatment failure was most effectively accomplished with surfactant and nitric oxide, with statistically significant MDs (MD, -0.734 [95% CI, -1.30 to -0.17] and MD, -0.6 [95% CI, -0.81 to -0.38], respectively).
The treatment group, compared with placebo, showed no statistically significant differences in lowering side effects, improving oxygenation index, or improving mortality.
References:
Elrosasy A, Maher A, Hammam NG, et al. Efficacy and safety of vasodilators for the management of persistent pulmonary hypertension of the newborn: a systematic review and network meta-analysis. The Heart Failure Society of America Annual Scientific Meeting; September 27-30, 2024; Atlanta, GA. Abstract 052.
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Beyond Air Provides LungFit® PH System To U.S. Naval Hospital Guam For Neonatal Critical Care In Partnership With TrillaMed
GARDEN CITY, N.Y., Sept. 27, 2024 (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, is proud to announce the deployment of its groundbreaking LungFit® PH system to the U.S. Naval Hospital Guam. This partnership, made possible through collaboration with TrillaMed, marks a significant advancement in the neonatal critical care unit, offering enhanced care for newborns in need of respiratory support.
The LungFit® PH system is an innovative device designed to generate Nitric Oxide (NO) from room air and deliver NO for the treatment of persistent pulmonary hypertension in neonates (PPHN), a condition that affects the lungs and heart of newborns. The system provides a safe, efficient, and user-friendly solution to address critical respiratory conditions, ensuring that the hospital's youngest and most vulnerable patients receive the highest standard of care.
Key Features of the LungFit® PH System:
"We are honored to support the U.S. Naval Hospital Guam in their mission to provide top-tier neonatal care," said Steve Lisi, CEO of Beyond Air. "Through our partnership with TrillaMed, we are able to extend the reach of our LungFit® PH, delivering critical solutions to the healthcare community. This collaboration is a testament to our commitment to advancing neonatal care and improving patient outcomes."
The U.S. Naval Hospital Guam serves as a critical care provider for the military community in the region. More than 17,000 active-duty military personnel and family members currently are stationed on Guam, which is expected to increase by 2,500 in the next two years. The U.S. Naval Hospital Guam delivers an average of 315 babies per year, with that number expected to rise to 487 births by 2033. The introduction of the LungFit® PH system underscores the hospital's dedication to utilizing state-of-the-art technologies in neonatal care, ensuring military families have access to the latest in respiratory treatment options.
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. For more information, visit www.Beyondair.Net.
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 Nitric OxideNitric 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 TrillaMed.TrillaMed is a premier provider of medical supplies and technologies to government and healthcare systems globally. As a trusted partner, TrillaMed delivers best-in-class solutions to meet the critical needs of healthcare providers, ensuring military personnel and their families receive the highest level of care.
CONTACTS:
Investor Relations contacts
Corey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.Com(212) 915-2577
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