Pittsburgh Life Sciences Greenhouse proudly broadcasts that portfolio firm ALung Applied sciences has obtained de novo clearance
ALung Technologies was originally supported by the PLSG seed funding
PITTSBURGH, November 23, 2021 / PRNewswire / – Pittsburgh Life Science Greenhouse (PLSG) is pleased to announce that one of its portfolio companies, ALung Technologies, Inc. (ALung), has announced that the Food and Drug Administration (FDA) has acquired De Novo Has given clearance for the hemolung breathing support system.
ALung is a leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for the treatment of patients with acute respiratory failure. The Hemolung System is the first and only ECCO2R device to be approved by the FDA.
“The FDA’s de novo review process is designed to determine that the clinical benefits outweigh the clinical risks of a medical device when there is no essentially equivalent predicate product,” 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 recognized the value of ALung’s technology early on and worked diligently to provide the support needed for its success, said the PLSG CEO Diana Cugliari. “We are especially proud and humble to know that hemolung has been used to treat more than 120 patients with severe COVID-19 respiratory failure.”
Steven Conrad, MD, PhD, MCCM, Medical Director at ALung and Professor of Medicine at Louisiana State University Health Science Center, said, “Hemolation will be an important new treatment for acute respiratory failure to prevent or mitigate the damage caused by invasive mechanical ventilation. FDA approval of hemolysis marks a turning point in the treatment of these critically ill patients and will usher in a new era in extracorporeal pulmonary assistance. “
ALung’s accomplishment is another great economic development success story for the region and for the Commonwealth of Pennsylvaniawho, according to Ms. Cugliari, have steadfastly supported the efforts of the PLSG. “This is a great milestone for ALung and once again underscores PLSG’s mission – to continue the life science startup cycle from inception to commercialization and leverage this success to build the next generation of life science companies to grow and enrich the economy of our region and advance scientific discoveries. “
The story goes on
The Pittsburgh Life Sciences Greenhouse (PLSG) is a comprehensive organization for economic development in the life sciences. We are committed to the further development of the life sciences in the west Pennsylvania by building on the region’s strengths in research, clinical care, and life sciences entrepreneurship. We serve our community by providing knowledge, connections, and capital to help businesses grow, create jobs, and improve the health of all human beings. More information is available at www.plsg.com.
ALung Technologies, Inc. is a privately held company Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of University of Pittsburgh, ALung developed hemolysis 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 on ALung and the Hemolung RAS, visit www.alung.com.
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SOURCE Pittsburgh Life Sciences Greenhouse