Imbed Biosciences has received FDA 510(k) clearance to market Microlyte® Ag/Lidocaine, a groundbreaking antimicrobial wound dressing that incorporates lidocaine for the treatment of painful skin wounds. This innovative dressing employs Imbed’s patented synthetic matrix to deliver both ionic and metallic silver alongside lidocaine, offering antimicrobial protection and local anaesthetic effects. The dressing releases 40 mg of lidocaine hydrochloride USP per 100 cm² of wound surface area, equivalent to a 4% w/w gel.

Microlyte® Ag/Lidocaine is designed for the management of various partial- and full-thickness wounds under healthcare supervision. These include venous stasis ulcers, pressure sores, ischemic ulcers, partial thickness burns, donor site wounds, surgical wounds, post-surgical incisions, abrasions, and lacerations.

In the $22 billion wound care market, over 8 million Americans suffer from chronic wounds, with about 60% remaining unhealed. These wounds often contain microbial biofilms, leading to annual healthcare costs exceeding $148 billion. The Microlyte® Ag/Lidocaine dressing is intended to enhance wound healing by suppressing microbial growth in contact with the dressing, maintaining a moist environment that supports cellular growth, and providing local anaesthetic relief through lidocaine.

This unique dressing has been shown to deliver sustained antimicrobial activity in simulated wound fluid for several days, effectively eliminating 99.99% of common clinical strains of gram-positive and gram-negative bacteria, as well as prevalent fungi.

The fully synthetic antimicrobial matrix combining silver and lidocaine is a significant development in wound care. It not only reduces the risk of wound infections but also offers potential temporary pain relief for some of the most painful wounds, which could lead to a decreased reliance on systemic antibiotics and opioids.

Last year, over 100,000 applications of the Microlyte® Matrix were utilised in wound care. This new version, which combines silver and lidocaine, reflects Imbed’s dedication to advancing standards in wound care and reinforces its position as a preferred choice for synthetic wound matrices in treatment protocols.




Source: businesswire.com

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