A commercial version of technologies developed in the McGowan Medical Devices Prototype Laboratory (MMDPL) at the McGowan Institute for Regenerative Medicine has moved one step closer to serving the needs of patients with respiratory distress. ALung Technologies, Inc., a University of Pittsburgh licensee, presented an analysis of its recent clinical trial of the Hemolung Respiratory Assist System (RAS) (pictured) in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). The results of a clinical study in Germany were summarized in a paper that was presented at the 58th Annual Conference of the American Society of Artificial Internal Organs in San Francisco.
The presentation, entitled "Extracorporeal CO2 Removal (ECCO2R) for Preventing Intubation in Patients with Exacerbated COPD: Results of the Hemolung Pilot Study," was presented by McGowan Institute for Regenerative Medicine faculty member William Federspiel, PhD, the William Kepler Whiteford professor of bioengineering, chemical engineering, and surgery, University of Pittsburgh, the director of the MMDPL, and Chairman of ALung's Scientific Advisory Board. The paper provided data from a subset of seven patients with acute exacerbation of COPD who were failing non-invasive ventilation and at a high risk of being intubated and placed on invasive mechanical ventilation. 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 to 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."