ULURU has signed a binding letter of intent with Exciton Technologies to develop and market a product that will combine Altrazeal with Exciton's 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 US Food and Drug Administration (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.
Exciton Technologies president Rod Precht said they are delighted to be working with ULURU to develop a product containing two patented technologies which appear to work synergistically to potentially provide clinical advantages.
"The initial in-vitro testing clearly indicates that Altrazeal exSALT has superior properties to the market leading products in this market category," Precht said.
It is anticipated that a 510(k) application will be filed with the FDA in approximately 90 days without any delays in approval of Altrazeal exSALT.