PITTSBURGH--(BUSINESS WIRE)--ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced the recent achievement of a significant milestone - enrollment of 100 patients in its U.S. based VENT-AVOID pivotal trial.
VENT-AVOID is a randomized, controlled pivotal trial (RCT) studying the avoidance or minimization of mechanical ventilation for the treatment of acute exacerbations of chronic obstructive pulmonary disease (AE-COPD). The results of the study are expected to validate the safety and efficacy of the Hemolung Respiratory Assist System (RAS) for COPD patients experiencing acute exacerbations requiring ventilatory support.
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.
“The VENT-AVOID pivotal trial is currently the world’s largest trial ever conducted on the utilization of ECCO2R in AE-COPD with 100 patients now enrolled. Pivotal trials of this magnitude have become increasingly difficult to conduct during the COVID-19 pandemic. However, the dedication and interest of our clinical trial sites has continued to grow as they have experienced the positive clinical impact of the Hemolung RAS and ECCO2R therapy. Based on recent declines in COVID-19 hospital admissions, we have experienced increases in screening and enrollment in the VENT-AVOID trial,” stated Tracey Dill, Vice President of Clinical Operations at ALung.
Peter M. DeComo, Chairman and CEO of ALung stated, “we are encouraged by the progress we have made with the VENT-AVOID trial during the past 12-months, especially during the most challenging times of the COVID-19 pandemic. Subsequent to receiving Emergency Use Authorization (EUA) from the FDA, ALung has provided ECCO2R therapy to 93 COVID-19 patients worldwide. Clinical experience utilizing the Hemolung RAS in treating the first 31 patients has recently been published in the Journal “Critical Care Explorations” and can be reviewed using the link below. The unique safety and simplicity features of the Hemolung RAS enable use with a broader base of clinicians as compared to existing conventional extracorporeal respiratory support systems. We expect that the VENT-AVOID trial, as well as other clinical data, will validate the safety and efficacy of the Hemolung RAS for the administration of ECCO2R therapy so that it will soon be available for use by clinicians worldwide when treating acute respiratory failure including AE-COPD.”
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.
For more information on the VENT-AVOID trial, and a list of enrolling sites, visit clinicaltrials.gov.
For the Critical Explorations Journal Article, visit https://journals.lww.com/ccejournal/Fulltext/2021/03000/Physiologic_Improvement_in_Respiratory_Acidosis.11.aspx?context=LatestArticles
The Hemolung RAS has not been FDA cleared or approved;
The Hemolung RAS has been authorized for the above emergency use by FDA under an EUA;
This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Hemolung RAS under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.
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.
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
