ALung Announces Commercial Development of its Next-Generation Artificial Lung

ALung Technologies Inc., provider of low-flow extracorporeal carbon dioxide removal (ECCO₂R) technologies for treating patients with acute respiratory failure, announced the recent initiation of commercial development of its next generation artificial lung, which expands the company’s focus on highly efficient gas exchange devices and also broadens its applicable market.
 
The company’s current product, the Hemolung Respiratory Assist System (RAS), is the only fully comprehensive extracorporeal carbon dioxide removal (ECCO₂R) system specifically designed and manufactured for this therapy, as compared to complex competitive products that are modifications of existing technologies designed for other purposes. The Hemolung continues to be the most highly efficient and simple to use ECCO₂R system on the market today.
 
The next-generation Hemolung RAS is based upon intellectual property recently licensed to ALung from the University of Pittsburgh. Developed by Professor William Federspiel, Ph.D., and colleagues at the Swanson School of Engineering and the McGowan Institute for Regenerative Medicine, this new technology platform significantly enhances gas exchange efficiency while reducing the deleterious hematologic effects from extracorporeal blood circulation. The licensed research was supported in part by the National Institutes of Health and the Coulter Translational Research Partners II Program at the University of Pittsburgh. Dr. Federspiel has an equity holding in the company and is compensated as an advisory board member.
 
“The next-generation Hemolung RAS is a direct result of the continued collaboration between the University of Pittsburgh and ALung Technologies. This collaboration, spanning 20-plus years, has resulted in a rich pipeline of innovation for ALung that will accelerate the development of highly efficient, simple to use artificial lung devices for the treatment of acute respiratory failure. The foundation of our next generation system is an integrated artificial lung cartridge/blood pump that will be unparalleled in the industry as the most efficient carbon dioxide removal and oxygen delivery system, which will address the needs of acute respiratory failure patients that require ECCO₂R and/or ECMO (extracorporeal membrane oxygenation). All of this will again be consolidated in a comprehensive, easy to use system without all of the complexities represented in competitive systems,” stated Peter M. DeComo, chairman and CEO of ALung Technologies.
 
Jeremy Kimmel, Ph.D., vice president of New Technology at ALung Technologies, stated, “Professor Federspiel and colleagues at the University of Pittsburgh have rapidly advanced this technology toward commercial readiness through state-of-the-art computational, in-vitro and in-vivo testing, including successful seven-day and 30-day large animal studies. ALung has initiated commercial development of the next-generation Hemolung RAS to provide clinicians with the flexibility to support patients across the full spectrum of acute and acute-on-chronic respiratory failure using a single integrated device. The system design will accommodate bedside therapy as well as portability and wearability, further enhancing device usability and expanding potential clinical indications.”
 
Key features and benefits of the next generation Hemolung RAS will include:

• Patent-pending technology that generates superior blood flow uniformity to maximize gas exchange efficiency.
• A custom designed centrifugal pump integrated with a low surface area (0.65 m²) gas exchange membrane without the need for additional components (e.g. heat exchanger, pressure ports) that will reduce operational complexity of the system.
• Low flow ECCO₂R (250 – 700 mL/min) as well as full ECMO (2 – 4 L/min) using a single integrated pump and gas exchange membrane.
• The highest efficiency oxygenation of any ECMO device on the market providing full oxygen saturation at ≤4 L/min blood flow with membrane surface area of 0.65 m².

 
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. ARDS is estimated to affect more than 10 percent of intensive care unit patients globally, has a mortality rate as high as 45 percent and requires invasive mechanical ventilation in the majority of cases.^3,4 Combined, these disorders represent a significant need and a global market for innovative respiratory assist devices. The COVID-19 pandemic is a recent example of such a dramatic need.
 
Currently, the Hemolung RAS has European marketing clearance (CE Mark). In addition, it is the only system that has been studied for safety and efficacy in two large landmark pivotal trials; the U.S. Food and Drug Administration (FDA)-approved VENT-AVOID trial and the U.K. REST trial. The Hemolung RAS was recently granted Emergency Use Authorization (EUA) by FDA for the treatment of acute respiratory failure caused by COVID-19.
 
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
³ Bellani. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016;315(8):788-800.
⁴ Walkey A. Acute respiratory distress syndrome: epidemiology and management approaches. Clinical Epidemiology 2012:4 159–169.