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ALung to Pursue SFDA Approval of Hemolung RAS in China

2013年05月21日 PM09:25
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PITTSBURGH

ALung Technologies, Inc., a leading developer of innovative respiratory assist devices, today announced that it has signed an agreement with Curative Medical, Inc. to pursue China’s State Food and Drug Administration (“SFDA”) approval for the Hemolung Respiratory Assist System (RAS).

Under the terms of the agreement, Curative Medical will supervise a clinical trial of the Hemolung RAS which provides Respiratory Dialysis® for patients in acute respiratory failure. ALung will contribute all of the necessary equipment and protocol support for the duration of the trial. Commercial distribution of the device in China is expected following receipt of SFDA approval.

“There is a clear clinical need for the Hemolung RAS in China,” said Peter DeComo, Chairman and CEO of ALung. “Over 65 million Chinese suffer from chronic obstructive pulmonary disease, primarily due to high rates of tobacco use. When patients with advanced COPD suffer sudden worsening of their symptoms, known as an acute exacerbation, they will sometimes require intubation and invasive mechanical ventilation as a lifesaving measure. With the Hemolung RAS, we can actually help these patients avoid intubation, allowing them to remain awake, communicate, and participate in their own rehabilitation.”

ALung’s agreement with Curative Medical was facilitated by David Iwinski of Blue Water Growth, a global business consulting firm. “We found a good partner in Curative given their strong position as leading developer and distributor of cardiopulmonary products in China,” said Nicholas Kuhn, President and Chief Business Officer of ALung. “Blue Water Growth was instrumental to the formation of this partnership, helping us successfully navigate what was a rather complicated process.”

Earlier in 2013, ALung was granted a Health Canada License and the CE Mark, allowing the Hemolung RAS to be marketed in Canada and throughout the European Union.

About ALung Technologies

ALung Technologies has developed the Hemolung RAS, a dialysis-like alternative or supplement to mechanical ventilation. The Hemolung RAS provides Respiratory Dialysis® by removing carbon dioxide and delivering oxygen directly to the blood, providing partial extracorporeal respiratory support in cases of acute respiratory failure.

http://www.alung.com

About Curative Medical Technologies

Curative Medical is a global cardiopulmonary medical device company with operations in the US, Germany and China. They are a leading manufacturer of non-invasive ventilation devices in China.

http://www.curativemedical.com

About Blue Water Growth

Blue Water Growth, LLC is a global business consulting firm with extensive on-the-ground experience and expertise in Asia. Its services include mergers and acquisitions, private capital solutions, product distribution, outsourcing, and a wide variety of business advisory services for its Western and Asian clients.

http://www.bluewatergrowth.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.

CONTACT

Media Contacts:
Blue Water Growth, LLC
Leslie
Ward, 412-667-0141
leslie.ward@bluewatergrowth.com
or
Pascale
Communications, LLC

Amy Phillips, 412-327-9499
amy@pascalecommunications.com

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