Australian Authorities Approve ALung Technologies’ CO2 Removal System

Pittsburgh, Pa.-based ALung Technologies Inc. has earned market clearance from the Australian Therapeutic Goods Administration (TGA) for its Hemolung Respiratory Assist System (RAS). The company has partnered with Medtel Australia Pty Ltd. to distribute the Hemolung RAS, which is the first low-flow extracorporeal carbon dioxide removal (ECCO2R) system to be approved and commercially available in Australia.

The Hemolung RAS is a dialysis-like alternative or supplement to mechanical ventilation for treating patients with acute respiratory failure, including those suffering from acute exacerbation of chronic obstructive pulmonary disease and acute respiratory distress syndrome. TGA approval allows the Hemolung RAS to be used in over 75 hospitals across Australia with level 3 intensive care units. The device is also cleared for use in Europe and Canada.

Distribution partner Medtel is a distributor of medical products, providing sales and service from offices in each mainland state in Australia.

“Medtel is most pleased to gain this key regulatory step in making the Hemolung technology available to the intensive care clinicians in Australia,” said Andrew Lehmann, managing director of Medtel Australia. “The Hemolung RAS is viewed as an innovative and market disruptive technology with the opportunity to provide patients with better outcomes and fewer lung complications. Medtel looks forward to partnering with ALung to promote and support the Hemolung product.”

The process for obtaining TGA approval took approximately a year. Prior to approval, three Australian hospitals had the opportunity to evaluate the Hemolung RAS under a special Authorized Prescriber program to access innovative medical devices.

“Minimally invasive ECCO2R devices like the Hemolung RAS have the potential to change the way we ventilate our critically ill patients by avoiding some of the life threatening side effects mechanical invasive ventilation,” said Hergen Buscher, M.D., staff specialist for intensive care medicine at St. Vincent Hospital, Sydney, who participated in this program.

“We are grateful for the support of Medtel, the Australian intensive care community, and the TGA as we worked through this approval process,” said Nicholas Kuhn, ALung president and chief business officer. “We are very excited to make the Hemolung RAS available to physicians all across Australia as they seek to optimize the care of their most critically ill patients.”