ALung Submits IDE Application to FDA Seeking Approval to Conduct Pivotal Study of the Hemolung RAS
PITTSBURGH (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.
About ALung Technologies
ALung Technologies, Inc. is a privately-held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.
For more information about ALung and the Hemolung RAS, visit www.alung.com.
This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company’s control. Events that could cause results to differ include failure to meet ongoing developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with regulatory approval processes, adverse changes to reimbursement for the Company’s products/services, and delays with respect to market acceptance of new products/services and technologies. Other risks may be detailed from time to time, but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.
Sr. Vice President of Market Development
ALung Technologies, Inc.
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