First US Patient Supported with the Hemolung RAS
Pittsburgh, PA (July 2, 2014) – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, issued the following statement today from ALung Chairman and CEO Peter DeComo:
“Yesterday, the Associated Press reported on the first ever use of our Hemolung RAS in the United States. The device was used under the FDA’s emergency use regulation by the University of Pittsburgh Medical Center (UPMC) as a last resort to save the life of Mr. Jon Sacker, a young man from Oklahoma with cystic fibrosis who was referred to UPMC in February for re-transplant following failure of his lungs due to a viral infection.
First and foremost, we would like to extend our best wishes to Mr. Sacker and his family as he continues to recover from his transplant surgery. Several of us have been fortunate to get to know the Sacker family and they are truly wonderful people. We look forward to hearing of Mr. Sacker’s ultimate discharge from UPMC and their return home to Oklahoma.
The request from Dr. Christian Bermudez to use the Hemolung RAS was made under FDA’s emergency use rules which permit physicians to utilize unapproved medical devices in life threatening situations where there are no suitable alternatives. Under these rules, Dr. Bermudez was required to obtain approval from UPMC’s institutional review board (IRB) and notify the FDA of his decision to use the device. The Hemolung RAS is not otherwise available for use in the United States.
ALung is actively working with the FDA to bring the Hemolung RAS to the US market. Because FDA has not previously approved any device like the Hemolung RAS which specifically provides partial extracorporeal CO2 removal, we are required to obtain a premarket approval (PMA). FDA has determined that we are not eligible to utilize the simpler 510(k) approval process under which many of the devices utilized for traditional extracorporeal membrane oxygenation (ECMO) have been approved. The PMA process will take us several years to complete as we will be required to conduct a large randomized controlled trial to demonstrate the safety and efficacy of the Hemolung RAS in a US patient population.
In the meantime, we continue to make significant progress with commercialization of the Hemolung RAS outside of the US where hundreds of patients have been treated with the device. Dr. Bermudez’s success with the device is echoed in the many reports we receive of the Hemolung RAS being instrumental to facilitating recovery from severe acute respiratory failure through either avoidance of intubation or minimization of mechanical ventilation and its harmful effects.
There is a clear paradigm shift taking place around how patients with acute respiratory failure are treated. The possibility of using next-generation extracorporeal devices like the Hemolung RAS to minimize or even replace mechanical ventilation is a key component of this evolution. All of us at ALung are very proud to be part of both Mr. Sacker’s case and all of the Hemolung cases around the world. We look forward to continued progress in this field, and helping to facilitate improved outcomes and quality of life for the many patients worldwide who suffer from lung disease.”
For more information about this story, including links to the AP report and a video from UPMC, visit http://www.alung.com/firstUSpatient
About ALung Technologies
ALung Technologies, Inc. is a privately-held Pittsburgh-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 and West Capital Advisors, LLC.
For more information about ALung and the Hemolung RAS, visit 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 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.
Vice President of Marketing and Clinical Affairs
ALung Technologies, Inc.
+1-412-697-3370 ext. 208
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