February New Products and Industry News
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SteadMed Medical is the first and sole US distributor of Drawtex, a patented, hydroconductive, nonadherent wound dressing with LevaFiber™ technology. This technology is a combination of two types of absorbent, cross-action structures facilitate movement of large volumes of fluid and other debris from the wound through the dressing. This hydroconductive action allows the dressing to lift, hold, and transfer the wound exudate both horizontally and vertically into the dressing, where it can absorb 500% of its own weight. The hydroconductive action disperses dressing contents in such a way that multiple layers of the dressing can be used for more heavily exuding wounds. The licensing and distribution agreement between the companies will allow SteadMed to bring a first-of-its-kind product into the US.
New agreement generates the development of an antimicrobial dressing
ULURU Inc (Addison, TX) has signed a Binding Letter of Intent (“Agreement”) with Exciton Technologies Inc (Edmonton, Alberta, Canada) to develop and market a product that combines ULURU’s Altrazeal® with Exciton’s proprietary exSALT™ Antimicrobial Technology. Exciton has developed a silver technology that has equivalent or greater antimicrobial efficacy at a lower silver concentration compared to other currently marketed silver products. Preliminary testing has been conducted on the combination of the products in an in vitro log reduction assay, which meets draft guidance from the FDA for testing of medical devices containing an antimicrobial agent.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 and was compared to five market-leading silver containing products.
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 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.
For more information, visit www.uluruinc.com.
Wound care system now available in the US
Spiracur® (Sunnyvale, CA), the developer of an ultraportable and single-use, negative pressure wound therapy (NPWT) device, has been added to Marathon’s Medical (Commerce City, CO) existing Federal Supply Schedule (FSS) contract, administered by the Department of Veterans Affairs (VA) on behalf of the US General Services Administration (GSA). The arrangement allows Spiracur to expand the availability of its SNaP® (Smart Negative Pressure) Wound Care System in partnership with Marathon Medical throughout the entire federal healthcare system, the largest healthcare provider in the US.
The newly secured contract offers opportunities to sell the wound care system and ensures that veterans and active soldiers have access to the device. Spiracur’s partnership with Marathon Medical offers a breadth of coverage within the VA system. The negative pressure system is changing the approach of how NPWT is delivered to patients. It eliminates electric or battery power in the healing process; therefore, the delivery device is completely silent, as well as lightweight and small (less than 3 oz). The wound care system is disposable and can easily fit under a patient's clothing, which has resulted in significantly improved patient acceptance and compliance of the therapy.
For more information, visit www.spiracur.com.