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ALung Submits IDE Application to FDA Seeking Approval to Conduct Pivotal Study of the Hemolung RAS

April 25, 2017

ALung Technologies, Inc., announced today the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) seeking approval to conduct a pivotal clinical study of the Hemolung Respiratory Assist System for the treatment of adults with severe acute exacerbations of chronic obstructive pulmonary disease (COPD).

COPD affects 30 million Americans1 and is the third leading cause of death in the United States behind cancer and heart disease.2 Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. For patients with severe exacerbations, high levels of carbon dioxide can result in respiratory failure and the need for intubation and mechanical ventilation as life-saving measures. Unfortunately, mechanical ventilation is associated with many side effects, and in-hospital mortality remains as high as 30%. The Hemolung technology aims to avoid or reduce the need for intubation and ventilator support by directly removing carbon dioxide from the blood.

ALung has been working with the FDA under the Expedited Access Pathway (EAP) program to complete pre-clinical testing and finalize its clinical study protocol. “Submission of our IDE is a significant milestone, made possible only through the hard work of our team in close collaboration with the FDA,” said Peter DeComo, Chairman and CEO of ALung. “We look forward to completing the IDE review and beginning the study later this year.”

ALung’s recently announced $36 million Series C financing, led by Philips and UPMC Enterprises, will support the clinical study program.

References

1. https://www.copdfoundation.org/What-is-COPD/COPD-Facts/Statistics.aspx

2. http://www.lung.org/assets/documents/research/copd-trend-report.pdf

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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