Pittsburgh, PA (January 14, 2015) – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, today announced that it has received marketing clearance from the Australian Therapeutic Goods Administration (TGA) for its Hemolung Respiratory Assist System (RAS). ALung has partnered with Medtel Australia Pty Ltd to distribute the Hemolung RAS which is the first 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 (COPD) and acute respiratory distress syndrome (ARDS). The TGA approval allows the Hemolung RAS to be utilized in over 75 hospitals across Australia with level 3 intensive care units. The device is also cleared for use in Europe and Canada.
ALung has partnered with Medtel Australia Pty Ltd to distribute the Hemolung RAS. Celebrating 50 years of operation in 2015, Medtel is a long established distributor of innovative medical products, providing sales and service from offices in each mainland state of the country. Andrew Lehmann, Managing Director of Medtel Australia stated, “Medtel is most pleased to gain this key regulatory step in making the Hemolung technology available to the intensive care clinicians in 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.”
Obtainment of TGA approval for the Hemolung RAS took approximately 12 months. Prior to receipt of the TGA approval, three Australian hospitals had the opportunity to evaluate the Hemolung RAS under a special Authorized Prescriber program to access innovative medical devices. Dr. Hergen Buscher, Staff Specialist for Intensive Care Medicine at St. Vincent Hospital Sydney who participated in this program, commented, “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 of mechanical invasive ventilation.”
“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.”
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-off from 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 Technologies and the Hemolung RAS, visit www.alung.com.
About Medtel Pty Ltd
Medtel Pty Limited is a supplier of high-end technology products and services to the medical and allied health care industry, with sales and service offices located across Australia and New Zealand.
Established in 1965, Medtel is part of The Getz Group of Companies, an international marketing and services company committed to excellence and with over 150 offices in 49 countries and 6 continents around the world. The Getz Group origins date back to as early as 1852.
Partnering with prominent global industry leaders, Medtel offers the latest in medical technology and is driven by the mission to make lives better through quality products and exceptional service.
For more information about Medtel, and for interest in the Hemolung RAS in Australia, visit http://www.medtel.com.au/.
This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as 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.
Source: ALung Technologies