PITTSBURGH, Nov. 23, 2021 /PRNewswire/ — Pittsburgh Life Science Greenhouse (PLSG) is proud to share that one of its portfolio companies, ALung Technologies, Inc. (ALung), announced that the Food and Drug Administration (FDA) has granted the company De Novo clearance for the Hemolung Respiratory Assist System.
ALung is a leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure. The Hemolung system is the first and only ECCO2R device cleared by the FDA.
“The FDA De Novo review process is designed to determine that the clinical benefits outweigh the clinical risks associated with a medical device when there is not a substantially equivalent predicate device,” said Peter M. DeComo, Chairman and CEO. “As a result, the De Novo process is quite rigorous. We look forward to introducing this new and valuable technology to the clinical market.”
PLSG identified early on the value of ALung’s technology and worked diligently to provide the support needed for success, according to PLSG CEO Diana Cugliari. “We are particularly proud and humbled to know that the Hemolung has been utilized in the treatment of more than 120 patients suffering from severe COVID-19 respiratory failure.”
Steven Conrad, MD, PhD, MCCM, Medical Director at ALung and Professor of Medicine at Louisiana State University Health Sciences Center, said, “The Hemolung will be an important new treatment modality for acute respiratory failure to avoid or mitigate the harms from invasive mechanical ventilation. FDA clearance of the Hemolung is a game-changer for the treatment of these critically ill patients and will usher in a new era of extracorporeal lung support.”
ALung’s accomplishment is another great economic development success story for the region and for the Commonwealth of Pennsylvania, who have steadfastly supported the efforts of PLSG, according to Ms. Cugliari. “This is a great milestone for ALung and once again underscores the mission of PLSG – perpetuating the cycle of life sciences startup companies from inception to commercialization and leveraging that success to grow the next generation of life sciences companies to enrich our region’s economy as well as advance scientific discovery.”
The Pittsburgh Life Sciences Greenhouse (PLSG) is a comprehensive life sciences economic development organization. We are dedicated to advancing life sciences in western Pennsylvania by building on the region’s strengths in research, clinical care, and life sciences entrepreneurship. We serve our community by providing knowledge, connection, and capital to help companies grow, create jobs, and improve the health of all humanity. For more information, please visit www.plsg.com.
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 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.
SOURCE Pittsburgh Life Sciences Greenhouse