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.
Contact: Company
Kerry P. Gray
President & CEO
Terry K. Wallberg
Vice President & CFO
(214) 905-5145
SOURCE ULURU Inc.