ABM RESPIRATORY COVER ANNOUNCES FDA CLEARANCE OF BIWAZE CLEAR.

EAGAN, Minn., Dec. 29, 2022 /PRNewswire/ – ABM Respiratory Care is a medical technology company that develops and commercializes innovative ventilation and airway clearance solutions. Today, the FDA 510(k), cleared the BiWaze by the U.S. Food and Drug Administration.^® Clear System. Clear System. This system clears the airways and prevents or treats atelectasis. BiWaze^® Clear can be used in hospital, long-term and home settings to treat acute and chronic respiratory conditions.

OLE therapy is a treatment that clears the airways of people suffering from respiratory conditions like cystic fibrosis, neuromuscular disorders and bronchiectasis. This therapy has been in use in hospitals for over 10 years and has been proved to be effective in clearing airways. OLE therapy was shown to reduce post-operative complications in the lungs by 31%. It also reduced the hospital stay time by 1.6 days. ¹.

BiWaze is an innovative technology^® The lightweight, battery-powered design of Clear makes it portable and easy to use anywhere. It delivers OLE therapy using a unique Dual Lumen Breathing Circuit™, which prevents exhaled aerosol from escaping the handset or breathing tube until it is filtered by a coaxial bacterial/viral filter. BiWaze® Clear delivers three therapies: lung expansion, high frequency oscillation and nebulization with the Aerogen^® Solo.

ABM Respiratory Care’s CEO said, “We continue to expand our portfolio with respiratory care products to help people with our technologies.” Vinay Joshi. “The BiWaze Clean System is designed to stop the spread of viral and bacterial infections, such as COVID-19. We are proud of this new OLE therapy.

ABM Respiratory Care

ABM Respiratory Care was founded in 2017 and is committed to improving patient care. We develop innovative, clinically differentiated respiratory care solutions that help patients breathe better both inside and outside of the hospital. Our connected platform is designed improve respiratory therapy by providing deep breathing, improved oxygen exchange and reduce aerosol emissions exposure. We also communicate for better disease management in all care settings around the globe for patients with compromised or impaired respiratory systems. More information is available at www.abmrc.com.

1. Huynh TT, Liesching TN, Cereda M, Lei Y, Frazer MJ, Nahouraii MR, Diette GB, Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication, Journal of the American College of Surgeons (2019)

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