ULURU Inc. Provides Update of Clinical Activities for Altrazeal
- Clinical Evaluation in Australia Expanded to 500 Patients -
- Comparative Study in Europe to Include 150 Patients -
ADDISON, Texas, May 3, 2012 /PRNewswire/ -- ULURU Inc. (OTCQB: ULUR) today provided an update on the worldwide clinical and commercial activities for Altrazeal.
Initially, it was planned to conduct a sixty patient study at five clinical centers to support the launch of Altrazeal in Australia and New Zealand. Due to the positive response Altrazeal has received, the ongoing clinical study has now been expanded to include 500 patients at fifteen clinical centers including a leading hospital in New Zealand. The objectives of the expanded clinical evaluation have been extended to include:
- Development of key opinion leader support for Altrazeal to influence doctors and nurses throughout Australia and New Zealand;
- To develop clinical evaluations to support contracts and hospital approvals;
- To work with the leading wound care universities to build brand support and further validate Altrazeal's benefits;
- To build a broad clinical experience and usage in the most influential hospitals; and
- To conduct clinical studies that will be published in wound care journals.
Commenting on the clinical evaluation Kerry P. Gray, President and CEO of ULURU Inc., stated, "The initial response received in Australia and New Zealand has been outstanding. The presentation on Altrazeal by a leading wound care physician from the United Kingdom at the recent wound care conference in Sydney, Australia was extremely well received generating a high level of interest. The results from this clinical evaluation and the proposed publications will be invaluable support of our global marketing activities. The overall cost benefit that Altrazeal offers in the treatment of wounds is an extremely important feature for the Australian market as cost containment and improved clinical outcomes have for many years been a high priority in Australia's health care system".
Also, our European partner is going to conduct a 150 patient comparative study in Europe to support price reimbursement. This study will compare the total treatment cost of Altrazeal relative to the current clinical practice. In addition to the product features that are scientifically engineered into Altrazeal to create an ideal wound healing environment, the benefit of once weekly dressing changes offers a major economic benefit to the various health care systems.
Mr. Gray continued, "This pharmaco-economic study will be instrumental in justifying premium pricing for Altrazeal in Europe. The comparative study will also be extremely beneficial to support marketing activities globally. Reducing the number of dressing changes or nursing visits offers the potential to significantly reduce overall treatment costs. A cost analysis for sixty days of treatment for a home health patient in the United States indicates the potential for cost savings of greater than 50%".
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 our website at 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, including but not limited to statements made relating to the progress of Altrazeal and our technologies, clinical and regulatory results for Altrazeal, advantages and cost benefit features of Altrazeal, anticipated product launches and regulatory filings, our ability to justify premium pricing in Europe, and the ability of Altrazeal to reduce treatment costs. When used in this press release, the words "may," "targets," "goal," "could," "should," "would," "believe," "feel," "hope," "expects," "confident," "anticipate," "estimate," "intend," "plan," "potential" and similar expressions may be indicative of forward-looking statements. These statements by their nature involve substantial risks and uncertainties, certain of which are beyond the Company's control. Any forward-looking statement speaks only as of the date on which such statement is made, and the Company undertakes no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of an unanticipated event. Further, management cannot assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These statements are subject to numerous risks and uncertainties, including but not limited to the risk factors detailed in the Company's Annual Report on Form 10-K for the year ending December 31, 2011 and other reports filed by us with the Securities and Exchange Commission.
SOURCE ULURU Inc.