ALung Technologies Receives Health Canada Approval for Hemolung Respiratory Assist System

PITTSBURGH--(BUSINESS WIRE)--ALung Technologies, Inc., a leading developer of innovative respiratory assist devices, announced today that it has received a Health Canada license for its Hemolung Respiratory Assist System (RAS). The Company has initiated commercialization activities worldwide in preparation for a global launch of the Hemolung RAS in 2013.

“Obtaining a Health Canada license signifies that the Hemolung RAS has met the rigorous safety, efficacy, and quality requirements of Canadian authorities”

The Hemolung RAS provides Respiratory Dialysis^® by removing carbon dioxide and delivering oxygen directly to the blood, allowing a patient’s lungs to rest and heal. The Company completed its European-based clinical trial of the device in 2011 and has been working with regulators to secure market clearances.

“Obtaining a Health Canada license signifies that the Hemolung RAS has met the rigorous safety, efficacy, and quality requirements of Canadian authorities,” said ALung Chief Executive Officer Pete DeComo. “Obtainment of this license is a very important milestone for the Company and a significant achievement for the employees of ALung who have worked for more than seven years to develop this groundbreaking technology.”

Through its Hemolung Reference Center Program, ALung will allow a select group of Canadian hospitals to have early access to the device before making it commercially available later this year. The Company has also begun establishing European operations in anticipation of obtaining the CE Mark, recently hiring direct sales and clinical staff in Germany and the United Kingdom, and signing distributors in several other key European markets.

The Hemolung RAS offers a simple, minimally invasive approach to extracorporeal carbon dioxide removal (ECCO₂R) through use of a small venous catheter and techniques similar to renal dialysis. “Clinical interest in ECCO₂R continues to build as intensive care physicians seek new ways to protect their patients from ventilator-induced lung injury and even from being placed on invasive mechanical ventilation altogether,” notes Nick Kuhn, ALung’s President and Chief Business Officer. “With the Hemolung RAS, we’ve developed a device that is very easy to use and provides clinically significant extracorporeal CO₂ removal in a less invasive way than existing extracorporeal gas exchange devices, such as ECMO. We’re very excited to be able to offer this device as a new tool for intensivists managing difficult to ventilate patients.”

About ALung Technologies

ALung Technologies, Inc. is a Pittsburgh-based developer and manufacturer of innovative lung assist devices. ALung’s Hemolung Respiratory Assist System (RAS) is a dialysis-like alternative or supplement to mechanical ventilation originally developed at the University of Pittsburgh. The Hemolung RAS provides Respiratory Dialysis^® by removing carbon dioxide and delivering oxygen directly to the blood and is indicated for providing partial extracorporeal respiratory support in cases of acute hypercapnic respiratory failure, including acute respiratory distress syndrome (ARDS) and acute exacerbation of chronic obstructive pulmonary disease (COPD). A simple extracorporeal circuit, small venous catheter, and techniques similar to hemodialysis make the Hemolung RAS easy to use.

For additional information, please visit: http://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.