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The National University Hospital, Singapore Pilots New Clinical Study of the Hemolung RAS Extracorporeal CO2 Removal System

2015年04月23日 PM10:33
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SINGAPORE

The National University Hospital, Singapore (NUH), and ALung Technologies, developer of low-flow extracorporeal CO2 removal (ECCO2R) technologies for treating patients with acute respiratory failure, today jointly announced the initiation of a new clinical study of the Hemolung Respiratory Assist System (RAS) to provide ECCO2R in patients with moderate-to-severe acute respiratory distress syndrome (ARDS). The first patient was recently enrolled in the study.

ARDS affects the critically ill, and is typically triggered by pneumonia, sepsis or trauma. These patients often require mechanical ventilation as a life saving measure. Unfortunately, mechanical ventilation can actually cause further lung injury, known as ventilator induced lung injury (VILI), which is thought to be the primary mechanism of worsening ARDS. This creates a difficult clinical situation, where the patient needs the ventilator to survive, but the ventilator can make the ARDS worse, resulting in mortality rates of up to 50%. A promising technique to break this vicious cycle of lung injury is the use of smaller ventilation volumes to achieve ultra-protective ventilation. However, when ventilation is reduced to protect the lung, carbon dioxide quickly accumulates in the patient’s blood, which causes the blood to become very acidic, and can impair the function of the heart and the immune system.

In this pilot study, Dr. Matthew Cove (Intensivist and Consultant, Division of Respiratory and Critical Care Medicine at the NUH), and his colleagues Dr. Zudin Puthucheary and Dr. Jason Phua, will assess the ability of low-flow ECCO2R provided by the Hemolung RAS to facilitate an ultra-protective ventilation bundle of care. The primary aim of this study is to demonstrate that this bundle of care can be safely applied while avoiding the negative effects of high carbon dioxide levels (hypercapnia) which result when ventilation volumes are reduced.

“To date, only one major intervention has consistently shown reduced mortality in ARDS patients – low tidal volume ventilation, referred to as lung protective ventilation,” stated Dr. Cove. “Despite these advancements, the optimal volume which protects the injured lung is not yet known. However, mounting evidence suggests that lower tidal volumes and plateau pressures than those we currently use, a strategy called ultra-protective ventilation, may be even more effective. A side effect of this strategy is carbon dioxide retention, which in this study will be controlled through the provision of ECCO2R with the Hemolung RAS.”

Prior studies of ECCO2R in ARDS patients have produced positive outcomes, but were limited in part by the capabilities of the previously available devices. Dr. Cove noted, “With the Hemolung device, we can now perform extracorporeal CO2 removal with a single venous catheter, which is similar to a dialysis catheter, and flow rates similar to those used in kidney dialysis. Our goal is to halt the progression of ARDS and facilitate lung recovery, while avoiding more invasive treatments like extracorporeal membrane oxygenation.”

Peter DeComo, Chairman and CEO of ALung, stated, “Dr. Cove and his team have developed a unique protocol which combines what we believe are all of the latest and most clinically effective strategies for improving outcomes in this group of ARDS patients for which mortality remains very high. We are very excited to support this study and anxiously look forward to its results.”

Up to 50 patients will be enrolled in the study with a 1:1 randomization to either the ECCO2R arm or standard of care. More details of the study can be found online at http://clinicaltrials.gov/show/NCT02252094.

About the National University Hospital, Singapore

The NUH is a tertiary hospital and major referral centre for a comprehensive range of medical, surgical and dental specialties. The Hospital also provides organ transplant programmes for adults (in kidney, liver and pancreas) and is the only public hospital in Singapore to offer a paediatric kidney and liver transplant programme.

Staffed by a team of healthcare professionals who rank among the best in the field, the NUH offers quality patient care by embracing innovations and advances in medical treatment.

In 2004, the NUH became the first Singapore hospital to receive the Joint Commission International (JCI) accreditation, an international stamp for excellent clinical practices in patient care and safety. Today, patient safety and good clinical outcomes remain the focus of the hospital as it continues to play a key role in the training of doctors, nurses and allied health professionals, and in translational research which paves the way for new cures and treatment, offering patients hope and a new lease of life.

A member of the National University Health System, it is the principal teaching hospital of the NUS Yong Loo Lin School of Medicine and the NUS Faculty of Dentistry. For more information, please visit www.nuh.com.sg

About ALung

ALung Technologies, Inc. is a privately-held Pittsburgh, Pennsylvania 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 individual investors and venture firms including Allos Ventures, Birchmere Ventures, Blue Tree Venture Fund, the Pittsburgh Life Sciences Greenhouse Accelerator Venture Fund, Riverfront Ventures, and West Capital Advisors, LLC.

For more information about ALung and the Hemolung RAS, visit www.alung.com

ALung Disclosure: This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well 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.

CONTACT

ALung Technologies
Scott Morley, VP Marketing, +1-412-697-3370
ext.208
smorley@alung.com
OR
National
University Hospital, Singapore
Christine Loh, Corporate
Communications, (65) 6772 5112 / (65) 9826 6695
Christine_loh@nuhs.edu.sg

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