ULURU Inc. Announces Approval to Market Altrazeal® in New Zealand
- Near Term Altrazeal® to be Launched in Six Markets -
- Approval to Market in China Anticipated in the Second Quarter-
ADDISON, Texas, March 20, 2012 /PRNewswire/ -- ULURU Inc. (NYSE Amex: ULU), announced today that Altrazeal® has been approved for marketing in New Zealand.
Commenting on the approval in New Zealand, Kerry P. Gray, President and CEO of ULURU, stated, "The approval for New Zealand is very timely as the Australian Wound Management Association Conference is currently being held in Sydney. At this conference key opinion leaders from both Australia and New Zealand are being introduced to Altrazeal®. To support the launch of Altrazeal® in Australia and New Zealand a five center, 60 patient study, has been initiated in Australia. A second 90 patient comparative study is planned to be conducted in Europe. This study is to support reimbursement submissions by demonstrating pharmacoeconomic benefits. These two studies will provide additional support for our global marketing activities."
With the New Zealand approval it is now anticipated that Altrazeal® will be launched in the near future in six additional markets for human and veterinary use.
Also, we have been recently advised by our licensee for China that approval is anticipated in the second quarter of 2012. The Altrazeal® regulatory submission is at the final stage of technical evaluation by the Center for Medical Device Evaluation. All updated certificates and materials have been submitted to the SFDA, the regulatory body for China.
Mr. Gray Continued, "With approval in China in the final phase we will now focus on further expanding our international network to include Canada, Latin America, additional S.E. Asia markets and South Korea. It is our objective to have Altrazeal® marketed in over 12 countries by the end of 2012. In addition, we have recently submitted a quotation to supply Altrazeal® to a Middle Eastern country. If successful, government tenders such as this can significantly enhance near term revenues."
About ULURU Inc.:
ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex™ Aggregate technology and OraDisc™ transmucosal delivery system. For further information about ULURU Inc., please visit our website at www.uluruinc.com. For further information about Altrazeal®, please visit www.Altrazeal.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended. These statements are subject to numerous risks and uncertainties, including but not limited to the launch of Altrazeal® in 12 countries in 2012, expanding our international network, receiving approval in China, completion of the proposed clinical studies, and to risk factors detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2010, and other reports filed by us with the Securities and Exchange Commission.
Kerry P. Gray
President & CEO
Terry K. Wallberg
Vice President & CFO
SOURCE ULURU Inc.