Subject: FDA
ABM RESPIRATORY CARE ANNOUNCES AN EXPANDED INDICATION FOR BIWAZE CLEAR
EAGAN, Minn., April 9, 2024 /PRNewswire/ -- ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel airway clearance and ventilation solutions, is excited to announce the expanded indication granted to the BiWaze® Clear System. The oscillating lung expansion (OLE) therapy of BiWaze Clear is intended to remove airway obstructions caused by retained secretions in the lower airways, as well as re-expand collapsed areas of the lungs, prevent respiratory tract infections, and enhance gas exchange and oxygenation. BiWaze Clear has now received FDA 510k clearance for use in-line with a ventilator in acute care environments.
This milestone presents acute care facilities with an innovative therapeutic option for ventilated patients suffering from atelectasis, retained secretions, or pneumonia. The inclusion of OLE therapy in-line with ventilators has demonstrated remarkable outcomes, including a 64% decrease in ventilator time and a 47% reduction in post-operative pulmonary complications among intubated patients.1
"This pivotal indication will greatly benefit our customers and patients," said Greg Miller, CEO at ABM Respiratory Care. "The expanded use of BiWaze Clear with ventilators underscores our commitment to continuously enhance patient care and highlights the versatility of our BiWaze platform."
BiWaze Clear initially received FDA 510k clearance in December 2022 for use with a face mask, mouthpiece, or trach adapter in acute and home care settings. This expanded indication further emphasizes ABM Respiratory Care's dedication to improving patient outcomes and advancing respiratory care.
About ABM Respiratory Care
Founded in 2017, ABM Respiratory Care is dedicated to advancing patient care by developing intelligent, clinically differentiated, and innovative respiratory care solutions to help people breathe better inside and outside the hospital. Our connected platform is designed to improve respiratory therapy by providing deeper breathing, improved oxygen exchange, reduce aerosol emission exposure, and communication for better disease management for people with compromised respiratory systems, in any care setting around the world. For more information visit, 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)
Investor and Media Contact:
Leah Noaeill
VP of Marketing and Clinical Affairs, ABM Respiratory Care
[email protected]
1.877.226.7201
SOURCE ABM Respiratory Care
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