ALung Technologies Presents Positive Clinical Trial Results of the Hemolung Respiratory Assist System
Pilot study shows the potential of the Hemolung RAS to help reduce the need for invasive mechanical ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD).
PITTSBURGH, Pennsylvania, June 18, 2012 – ALung Technologies, Inc., a leading developer of innovative lung assist devices, presented an analysis of its recent clinical trial of the Hemolung Respiratory Assist System (RAS) in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). The data were presented during the session “Chronic and Acute Hypercapnic Failure – Management with low flow CO2 devices” on Friday, June 15th at the 58th Annual Conference of the American Society of Artificial Internal Organs (ASAIO) in San Francisco.
The presentation, entitled “Extracorporeal CO2 Removal (ECCO2R) for Preventing Intubation in Patients with Exacerbated COPD: Results of the Hemolung Pilot Study,” by Dr. William Federspiel, Professor of Bioengineering at the University of Pittsburgh and Chairman of ALung’s Scientific Advisory Board, provided data from a subset of seven patients with acute exacerbation of COPD who were failing non-invasive ventilation (NIV) and at a high risk of being intubated and placed on invasive mechanical ventilation (IMV). Patients in the study were provided ECCO2R with the Hemolung RAS to remove retained carbon dioxide. The study was led by principal investigator Prof. Dr. Felix Herth of the Thoraxklinik and University Hospital, Heidelberg, Germany.
In his presentation, Dr. Federspiel highlighted the improvement in respiratory status seen in these patients with severe exacerbations in which the Hemolung RAS was applied. Arterial pCO2 levels were reduced on average by 28% within 24 hours, leading to lessening dyspnea and improved clinical status. The device provided effective and stable CO2 removal on the order of 75 to 95 mL/min or up to approximately 50% of metabolic production. No unexpected adverse events were observed. All patients were able to avoid intubation while treated with the Hemolung RAS.
COPD afflicts over 14 million Americans and leads to nearly 140,000 deaths annually, making it the third leading cause of death. Acute exacerbations are a serious complication of COPD in which patients suffer a sudden worsening of their symptoms. In severe cases, patients will develop acute respiratory failure and require invasive mechanical ventilatory support. “These patients that go on to be mechanically ventilated often have a very poor prognosis with survival ranging from 31% to 76%,” said Dr. Nausherwan Burki, Professor of Medicine at the University of Connecticut Health Center and ALung’s Medical Director. “The ability of the Hemolung RAS to help patients with severe acute exacerbation of COPD avoid intubation and invasive mechanical ventilation fills an important, unmet clinical need.”
“We are pleased to have completed our pilot study of the Hemolung RAS and to be progressing towards obtainment of the CE mark,” said Peter DeComo, ALung’s Chairman and CEO. “There is tremendous clinical enthusiasm for the Hemolung RAS, and we’re looking forward to introducing the product to key reference centers throughout Europe in the near future.”
About ALung Technologies, Inc.
ALung Technologies, Inc. is a Pittsburgh-based developer and manufacturer of innovative lung assist devices. ALung is commercializing the Hemolung Respiratory Assist System (RAS), a dialysis-like alternative or supplement to mechanical ventilation originally developed at the University of Pittsburgh. The Hemolung RAS provides Respiratory DialysisTM by removing carbon dioxide and delivering oxygen directly to the blood, allowing the patient’s lungs to rest and heal. A simple extracorporeal circuit, small venous catheter, and techniques similar to hemodialysis make the Hemolung RAS easy to use. The Hemolung RAS is currently an investigational device, and is not yet available for sale in any market.
For additional information, please visit: https://www.alung.com
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 the FDA/regulatory approval process, 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.
ALung Technologies, Inc.
Vice President of Marketing