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ULURU Inc. (Amex: ULU) today announced the Company's launch plan for Altrazeal(TM) and the commercial availability of the product commencing the week of May 19, 2008. Altrazeal(TM) is the first wound care dressing to be developed from our nanoparticle aggregate technology. It is an easy to apply and remove powder hydrogel that in the presence of body fluids rapidly converts to a gel material which fills and seals the wound, promoting an optimal moist healing environment and reduces the need for multiple dressing changes.
The Altrazeal(TM) launch meeting, including the training of our sales force, has been conducted during the past two weeks. As part of the training, our sales organization attended the American Burn Association ("ABA") Annual meeting in Chicago last week where Altrazeal(TM) was demonstrated. The response from the physicians and nurses to the product was very positive and it was seen as a potentially significant improvement to the treatment and patient care of burn victims.
The market research conducted by the Company indicates the importance of trial usage by the burn care centers as the first step in the decision making process. Consequently, the initial focus of the sales force has been, and will continue to be during the initial launch phase, securing key opinion leader support from nationally recognized burn centers. During the ABA meeting in Chicago, great progress was made establishing the necessary relationships with the leading burn centers to commence patient usage upon the availability of the product.
Our product features and benefits are ideally suited to the burn care market. The ease of application and removal and reduced need for dressing changes will enhance patient comfort. Once Altrazeal(TM) has been established in the burn market, additional efforts will be directed at wound care centers and the use of Altrazeal(TM) for the treatment and management of chronic wounds.
Commenting on the launch of Altrazeal(TM), Renaat Van Den Hooff, Executive Vice President-Operations of ULURU commented, "This is a major milestone in the development of the Company and a significant achievement, having overcome all the challenges associated with production scale-up. It is an exciting period for the Company as we build our sales force and commercial infrastructure. The market research and response from physicians and nurses gives us a high level of confidence that Altrazeal(TM) will be perceived as a transformational innovation in the wound care market. We believe that by rapidly establishing key opinion leader support we can quickly build a solid foundation from which we plan to penetrate the burn market."
The Company's focus is to add two products to our wound care franchise in 2009. The first product under development is an antimicrobial dressing containing silver. The necessary toxicology studies for submission of a 510k regulatory application are nearing completion and production scale-up for blending the product has commenced. We expect to file a 510k application with the FDA in the third quarter of 2008, with the product launch being planned for first quarter 2009.
Mr. Van den Hooff continued, "Adding a silver product to our wound care franchise is very important as infection control is a high priority for physicians. Bringing this product to market as soon as possible is our highest product development priority."
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 response to the product from physicians and nurses, the importance of use of the product for burn victims, our expectation of enhanced patient comfort, the ability to use the product for chronic wounds, the perception of the product as a transformational innovation in the wound care market, our plan to add two products to our wound care franchise in 2009, and our expectation of filing a 510k in the third quarter and a product launch in the first quarter of 2009. 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, 2007, Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 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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