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ULURU Inc. today provided an update on the status of its wound care franchise.
In preparation for the launch of Altrazeal(TM) our first wound care product, which is scheduled to occur in the second quarter 2008, the Company is conducting numerous market research surveys. The first study completed targeted burn specialists, emergency room and trauma doctors and doctors from wound care clinics, additionally nurses from these specialized areas were also interviewed. The primary objectives of the research were to evaluate the positioning of the product relative to the present standard of care, to determine the most important sales message and receive feedback on pricing, packaging and other launch information. The results of this study indicate that the product concept is very favorably received with positive responses related to the ease of use, less frequent dressing changes, no need for a secondary dressing and the ability of Altrazeal(TM) to seal and conform to the wound. The study also revealed that improved patient and provider compliance is also considered an important issue as these are keys to the effective treatment of a wound. Altrazeal(TM) was considered a highly innovative product offering a unique selling proposition. Importantly Altrazeal(TM) also scored very highly on intent to use.
Additionally, the Company is conducing a comprehensive market research study to finalize Altrazeal(TM)'s pricing. This market research is not only analyzing competitive pricing structures but also evaluating the impact on pricing of the numerous healthcare providers that service the acute and chronic wound care markets.
To support the Altrazeal(TM) launch the Company is expanding the clinical trial program to include additional clinical centers and wound types. Expanding the number of centers conducting smaller clinical studies comparing Altrazeal(TM) to the standard of care in that center is expected to provide additional support for our launch activities. To date the focus of the clinical program has been acute wounds and burns. We are now in the process of expanding our clinical program to include chronic wounds such as pressure sores.
In preparation for the Altrazeal(TM) launch the company has commenced hiring a direct sales force and the sales and marketing administration to support commercialization activities. In addition the company is evaluating strategic alternatives to further support the sales and marketing activities for Altrazeal(TM).
Commenting on the status of the Altrazeal(TM) launch activities, Renaat Van den Hooff, Executive Vice President of Operations, stated, "Significant progress has been made in preparation for the launch of Altrazeal(TM). The market research data not only confirms the exciting potential of Altrazeal(TM) but it also highlights the need for product improvements in wound care, the willingness of the medical practitioners to try new products and the ability of direct sales representatives to make effective calls on the target audience. The expansion of our clinical program is designed to support the use of Altrazeal(TM) in expanded wound types and to have a broader group of physicians familiar with Altrazeal(TM) prior to launch."
The development of our next generation product, which contains silver in the base powder dressing, has advanced to commercial scale evaluation studies. We plan to file in 2008 a 510 (K) application for approval by the FDA, with a launch planned for 2009. Marketing a silver containing product is important especially in certain wound types where infection is a major concern. These products are extensively used in such conditions as control of infection is essential for wound healing.
Mr. Van den Hooff continued, "Our strategy is to develop a range of wound care products to meet the various needs of patients, doctors and nurses. A silver containing product is an important line extension to expand our product offering. Development has commenced in our laboratories to incorporate additional active ingredients to further expand the product line to include debridement agents, activities to promote healing and pain relief drugs."
About ULURU Inc.
ULURU Inc. is an emerging specialty pharmaceutical company focused on the development of a portfolio of wound management, plastic surgery and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative transmucosal delivery system and Hydrogel Nanoparticle Aggregate technology.
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 sales potential of Altrazeal(TM), the launch date of Altrazeal(TM), the Altrazeal(TM) clinical plan and the development of a range of wound care products. 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-KSB for the year ended December 31, 2006, Quarterly report on Form 10-QSB for the quarter ended September 30, 2007 and other reports filed by us with the Securities and Exchange Commission.
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Kerry P. Gray
President & CEO
Terry K. Wallberg
Vice President & CFO
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