Navigation Links
ULURU Inc. Announces the Filing of a 510k Submission With the FDA for Altrazeal(TM) Silver
Date:9/30/2008

ADDISON, Texas, Sept. 30 /PRNewswire-FirstCall/ -- ULURU Inc. (Amex: ULU) today announced that it has filed a 510k application with the United States Food and Drug Administration (FDA) for Altrazeal(TM) Silver.

Preclinical studies conducted to support the filing have shown that superior healing rates in numerous porcine wound models have been achieved relative to competitive silver dressings. Additionally, in toxicology and in vitro bacteria inhibition studies Altrazeal(TM) Silver has performed favorably relative to competitive silver dressings. This data should favorably position Altrazeal(TM) Silver in the market, providing benefits to both the patient and the health care provider.

The use of silver in wound care is increasing rapidly in the management of infected wounds and wounds at risk for infection. Silver has been used extensively as a broad-spectrum antimicrobial particularly in the treatment of chronic wounds and to manage burn infections. Wounds exhibiting increased bacterial burden have reduced healing responses when compared to wounds containing fewer bacteria.

Commenting on the 510k filing, Kerry P. Gray, President and CEO of ULURU Inc. stated, "This is an important milestone in the development of our wound care franchise. In certain wound types silver-containing products are used extensively by physicians. We have responded to a market need by developing Altrazael(TM) Silver as our sales organization has received consistent feedback from wound care practitioners that a silver containing Altrazeal(TM) is one of the products that would improve wound treatment. We expect to launch Altazeal(TM) Silver in the first quarter 2009."

In addition to being a superior wound dressing Altrazeal(TM), which incorporates our Nanoflex(TM) technology, is also a controlled drug delivery technology enabling active wound healing agents to be delivered to the wound bed over periods of up to 30 days. Altrazeal(TM) Silver is the first in a series of planned line extensions designed to improve the treatment of both acute and chronic wounds. The company strategy is to develop additional Altrazeal(TM) products incorporating active compounds for the treatment of the various phases of wound healing, infection, inflammation, debridement, maturation and closure. By implementing this strategy we believe that we will be delivering the products necessary to significantly improve wound healing.

Gray continued, "Our objective is to transform wound healing from "dressing a wound" to "treating a wound" by providing a range of products for the various phases of wound healing. The initial clinical data on Altrazeal(TM) which will be presented at an upcoming wound conference in Las Vegas at the end of October is very exciting. Time to healing in numerous chronic, acute and traumatic wounds is significantly shorter than physicians have previously experienced. We believe that we can further improve wound treatment with our planned introduction of actives in the Altrazeal(TM) dressing."

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(TM) 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 response to the product from physicians and nurses, the importance of use of the product for burn victims, 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 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 June 30, 2008 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


'/>"/>
SOURCE ULURU Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. ULURU Inc. to Present at the 8th World Biomaterials Congress
2. ULURU Inc. Announces Update on Recent Development
3. ULURU Inc. Reports Second Quarter 2008 Financial Results
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
6. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
7. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
8. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
9. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... The two ... healthcare treatment options for patients. Vironika, a spin out from The Wistar Institute, and ... taking lab space at 3624 Market Street. , Vironika is developing a treatment ...
(Date:1/20/2017)... January 20, 2017 http://www.Financialbuzz.com ... one of leading causes of death worldwide. There were ... number of cancer related deaths increased gradually over time, ... incidence rate of various cancers continues to drive demand ... report by Global Market Insights, Inc. cancer biological therapy ...
(Date:1/19/2017)... 19, 2017  Market Research Future has a half cooked research ... Biopsy is growing rapidly and expected to reach USD 450 Million ... ... Biopsy Market has been assessed as a swiftly growing market and ... in the coming future. There has been a tremendous growth in ...
(Date:1/19/2017)... Jan 19, 2017 Research and Markets ... has announced the addition of the ... - Forecast to 2025" report to their offering. ... The report provides a detailed analysis on current and future market ... 2025, using estimated market values as the base numbers ...
Breaking Biology Technology:
(Date:12/19/2016)... España y TORONTO , 19 de diciembre de ... Biologics Inc. que permitirá el desarrollo acelerado de MSC-1, un anticuerpo ... varios tipos de tumor en 2017, con múltiples sitios previstos a ... ... con objetivo en el factor inhibidor de leucemia (LIF), una citoquina ...
(Date:12/16/2016)... 2016 Research and Markets has announced the ... Forecast to 2021" report to their offering. ... The biometric vehicle access system ... CAGR of 14.06% from 2016 to 2021. The market is estimated ... reach 854.8 Million by 2021. The growth of the biometric vehicle ...
(Date:12/15/2016)... Germany , December 15, 2016 ... announced an agreement with NuData Security, an award-winning ... partnership will enable clients to focus on good customer experience, ... protection regulation. ... In order to provide a one-stop fraud prevention suite, ...
Breaking Biology News(10 mins):