ADDISON, Texas, July 26 /PRNewswire-FirstCall/ -- ULURU Inc. today announced that it has commenced a clinical study to evaluate the mobility of severely burned joints treated with its patented Hydrogel Nanoparticle Wound Dressing as compared to the current standard of care. This clinical trial is one of numerous studies that are being conducted to support the marketing of our wound dressing. This study is designed to provide support for a new standard of care for patients undergoing treatment and physical therapy for burns to joints.
The study is being conducted at the University of Texas Southwestern Medical Center and Parkland Health and Hospital System in Dallas, Texas. The mobility of burned joints dressed with the Hydrogel Nanoparticle Wound Dressing will be compared to wounds dressed with a commercial carboxymethylcellulose dressing. Approximately 40 patients are expected to be enrolled in the study and it is anticipated that the study will take 4 months to complete. Extensive preclinical studies in several porcine wound models using the ULURU Hydrogel Nanoparticle Wound Dressing support the use of the dressing in this indication. These studies indicate that our wound material remains flexible and in intimate contact with the wound bed, maintaining a moist wound environment for enhanced wound healing for periods up to 28 days without requiring a secondary dressing to hold our material in place.
Commenting on the study, Dr. Rod J. Rohrich, Professor and Chairman of Plastic Surgery the University of Texas Southwestern Medical Center stated, “The results of extensive pre-clinical porcine wound healing studies conducted in our laboratories demonstrate the wound healing properties of ULURU’s wound dressing material. These results support the potential for this wound dressing to significantly improve patient care in numerous wound care applications. Patients with burned joints encounter difficulty in undertaking physical therapy or resuming normal activities using conventional dressings on burned tissue. The development of a wound dressing that remains intact and flexible on a healing burn, without the need for removal during physical therapy, would be a major clinical advancement for treating this type of injury.”
Kerry P. Gray, President & CEO of ULURU Inc., stated “This study will provide us with the initial clinical data for our Hydrogel Nanoparticle Wound Dressing. This is the first important step in translating the unique properties of our patented wound care technology into real clinical advances. An extensive clinical development plan to support the marketing of our wound dressing is being implemented which incorporates numerous clinical centers, including the military, and a variety of indications including both acute and chronic wounds.”
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. For further information about ULURU Inc., please visit our website at http://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 establishment of a new standard of care for burn patients, the number of patients to be enrolled in the study and the time it will take to complete the study, result from previous preclinical studies and clinical study outcomes. 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 March 31, 2007 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
ULURU Inc.
CONTACT: Kerry P. Gray, President & CEO, or Terry K. Wallberg, VicePresident & CFO, +1-214-905-5145, both of ULURU Inc.
Web site: http://www.uluruinc.com/
