Hemolung® RAS Used to Treat More than 75 COVID-19 Patients

ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO₂R) technologies for treating patients with acute respiratory failure, announced that it has now treated more than 75 COVID-19 patients, and that it is experiencing increasing demand for the Hemolung^® Respiratory Assist System (RAS) as a result of the current pandemic. The Food and Drug Administration (FDA) granted the Company Emergency Use Authorization (EUA) designation to the Hemolung RAS for the treatment of COVID-19 patients in the second quarter of 2020. The Hemolung is the only ECCO₂R device currently granted an EUA for the treatment of COVID-19.

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“The Hemolung RAS has enabled us to recover patients with COVID pneumonia during the pandemic. In select patients where there is a selective issue with hypercarbic respiratory acidosis while their oxygen requirements have normalized post-Veno-Venous ECMO cannulation, we have utilized Hemolung as a bridge in their recovery. We have noticed that these patients are able to wean off mechanical circulatory support in a gradual manner. Additionally, at a time when there was a shortage of ECMO circuits, our program has relied on utilizing this technology in stabilizing patients with severe hypercarbic respiratory acidosis while providing lung protective ventilation,” stated Dr. Bindu Akkanti, MD, Associate Professor of Medicine, Divisions of Critical Care, Pulmonary and Sleep Medicine, McGovern Medical School, and Director of Heart and Vascular Critical Care, Memorial Hermann - Texas Medical Center.

“The Hemolung RAS has given us a new tool during the current pandemic, to safely and easily treat our COVID-19 patients. We were able to rapidly introduce the Hemolung RAS to our staff and start treating patients under Emergency Use Authorization. As a smaller community hospital without an ECMO program, the ease of use of the Hemolung has played a large role in the successful deployment of ECCO₂R for the treatment of COVID-19 at Palm Beach Gardens Medical Center,” stated Ribal Darwish, MD, Medical Director Critical Care Medicine, Palm Beach Gardens Medical Center.

“We are pleased to be able to assist in this fight against the COVID-19 viral disease by providing the use of the Hemolung RAS as a tool for physicians to be used in conjunction with IMV, by reducing or eliminating the potential of further lung damage caused by high ventilator driving pressures, often referred to as Ventilator Induced Lung Injury (VILI). We are treating COVID-19 patients in greater than 20 hospitals worldwide,” said Mr. Peter M. DeComo, Chairman and CEO of ALung Technologies.

In its EUA approval letter to ALung the FDA stated that it believes the Hemolung RAS has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation, to reduce hypercapnia and hypercapnic acidosis due to COVID-19, and/or to maintain normalized levels of partial pressure of carbon dioxide(PCO₂) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO₂ cannot be adequately, safely, or tolerably achieved and, in turn, may provide clinical benefit, and that there is no adequate, approved and available alternative to the emergency use of the Hemolung RAS to treat lung failure caused by COVID-19.

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, please visit clinicaltrials.gov.

For more information on the use of the Hemolung RAS for COVID-19 patients, please visit https://www.alung.com/covid-19/covid-19-us/

*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.

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