ULURU INC. ANNOUNCES THE COMMENCEMENT OF FIRST CLINICAL STUDY USING ALTRAZEAL™ SILVER - Multi-Center Study in Skin Graft Donor Site Patients
Addison, Texas, October 21, 2008; ULURU Inc. (NYSE Alternext: ULU)
today announced that it has commenced a clinical study to evaluate patients with graft donor sites treated with ALTRAZEAL Silver compared with a market leading silver containing carboxymethylcellulose dressing. The study will be conducted at four clinical sites with 40 evaluable patients being enrolled. The first study site has been initiated and the Company plans to initiate additional sites within the next 30-days.
Each patient will have two skin graft donor sites, with ALTRAZEAL Silver being applied to one site and the competitive dressing being applied to the other site. The primary study objective is to evaluate wound healing. Secondary study objectives include evaluating the incidence of wound infection, number of dressing changes, patient pain and provider and patient satisfaction.
This study is designed to support the marketing of ALTRAZEAL Silver and provide the necessary clinical data to apply for a CE mark which will enable ALTRAZEAL Silver to be marketed in Europe and Canada.
Commenting on the clinical study, Renaat Van Den Hooff, Executive Vice President of Operations stated, “Silver containing dressings are used extensively in the skin graft donor site indication to protect against infection. Preliminary data that has been generated in skin graft donor sites with ALTRAZEAL is very positive, indicating that both patient comfort and pain are improved with ALTRAZEAL. With the use of silver containing dressings increasing in both chronic wounds and burns, this product line extension is an important component of our wound care franchise.”
Silver has broad-spectrum antimicrobial properties which is ideal for use in preventing and treating infected wounds and wounds at risk of infection. Reducing bacteria burden in the wounds has been shown to improve healing. In preclinical studies, using a porcine wound healing model, ALTRAZEAL silver showed superior healing rates compared to competitive silver dressings.
The company strategy is to develop a range of ALTRAZEAL products incorporating active compounds for the treatment of the various phases of wound healing, infection, inflammation, debridement, maturation and closure. ALTRAZEAL Silver will be the first product to demonstrate execution of this strategy (by implementing this strategy we believe that we will be delivering the products necessary to significantly improve wound healing).
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 Nanoflex™ Aggregate technology. For further information about ULURU Inc., please visit our website at www.uluruinc.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 response to the product from patients, the ability to use the product for chronic wounds, the product accelerates healing and decreases pain, decreases dressing changes and reduction in wound management nursing time. 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 June 30, 2008 and other reports filed by us with the Securities and Exchange Commission.