ULURU Inc. announced today that it has signed a Binding Letter of Intent with Exciton Technologies Inc. to develop and market a product that will combine Altrazeal® with Exciton's proprietary exSALT™ Antimicrobial Technology.
Under the terms of the agreement ULURU will be granted a worldwide license, excluding China, to market the Altrazeal® exSALT™ product. Exciton will be responsible for conducting the necessary product testing, filing a 510(k) application with the FDA and interacting with the FDA to secure product approval. ULURU will be responsible for product approval in International markets including gaining CE Mark approval. ULURU will pay Exciton to prepare and prosecute the 510(k) application, milestone payments on the attainment of sales targets and a royalty based on product sales. The parties have agreed to negotiate a final agreement that will supersede the Binding Letter of Intent.
Exciton has developed a unique silver technology which has equivalent or greater antimicrobial efficacy at a markedly lower silver concentration compared to other currently marketed silver products. Preliminary testing has been conducted on the combination of Altrazeal® and exSALT™ in an in-vitro log reduction assay, which meets draft guidance from the FDA for testing of medical devices containing an antimicrobial agent. This testing has been performed against Staphylococcus aureus, one of the more resistant bacterial strains. The performance of Altrazeal® exSALT™ was compared to five market leading silver containing products. Of the five commercial products tested only two products passed this antimicrobial efficacy test and both of these products contained significantly more silver (3.75 and 7.50 times more silver) than Altrazeal® exSALT™.
Commenting on the Agreement, Rod Precht, President of Exciton Technologies Inc., stated, "We are delighted to be working with ULURU to develop a product containing two patented technologies which appear to work synergistically to potentially provide significant clinical advantages. The initial in-vitro testing clearly indicates that Altrazeal® exSALT™ has superior properties to the market leading products in this market category."
It is anticipated that a 510(k) application will be filed with the FDA in approximately 90 days. Assuming no extended delays in FDA review, approval of Altrazeal® exSALT™ could occur as early as the third quarter of 2011. The antimicrobial segment of the North American advanced wound care market is projected to grow in the next 5 years to be in excess of $750 million with annual growth rates above 15%.
Commenting on the Agreement, Kerry P. Gray, President and CEO of ULURU Inc., stated, "Combining these two leading technologies offers the potential for a dominant product in the antimicrobial dressing market. The superior antimicrobial activity at a significantly lower silver concentration is an outstanding product benefit. As we assessed our silver product strategy, given the favorable product profile of Altrazeal® exSALT™, it became obvious that this was our best course of action compared with pursuing our prior silver product application. This revised strategy also addresses questions previously raised by the FDA."