Imbed Biosciences Receives FDA 510(k) Clearance for Microlyte® Ag/Lidocaine

First antimicrobial wound dressing with integrated lidocaine to manage painful wounds

Imbed Biosciences announces U.S. Food and Drug Administration 510(k) clearance to market Microlyte® Ag/Lidocaine, the first antimicrobial wound dressing to integrate lidocaine for the management of painful skin wounds. Microlyte® Ag/Lidocaine utilizes Imbed’s patented synthetic matrix to deliver ionic and metallic silver alongside lidocaine, providing both antimicrobial protection and local anesthetic effects. The dressing releases 40mg of lidocaine hydrochloride USP per 100cm² of wound surface area, equivalent to a 4% w/w gel. The advanced Microlyte® Ag/Lidocaine wound dressing is indicated for the management of a variety of partial- and full-thickness wounds under the supervision of a healthcare professional, including venous stasis ulcers, pressure sores, ischemic ulcers, partial thickness burns, donor site wounds, surgical wounds, post-surgical incisions, abrasions and lacerations.

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In the $22 billion wound care industry targeting both acute and chronic wounds, over 8 million Americans suffer from chronic wounds, with approximately 60% remaining unhealed. These wounds often harbor microbial biofilms, contributing to over $148 billion in annual healthcare costs. Microlyte® Ag/Lidocaine is designed to facilitate wound healing progression in deteriorating wounds by suppressing the growth of microbes in contact with the dressing, maintaining a moist matrix environment conducive to cellular growth, and releasing lidocaine to effect local anesthetic action.

“Our patented polymeric matrix architecture incorporates both silver and lidocaine in the dressing enabling the two active ingredients to provide both antimicrobial and anesthetic benefits locally to the patient,” said Dr. Ankit Agarwal, PhD, co-founder and Chief Scientific Officer of the company. “We are the first to demonstrate that stable formulations of silver and lidocaine can be incorporated in a combination device. Additionally, this achievement demonstrates the ability to use Microlyte® Matrix as an effective drug-delivery platform, creating the potential for numerous pipeline opportunities to improve wound care.”

The fully-synthetic antimicrobial wound matrix with lidocaine was shown to provide sustained antimicrobial activity in simulated wound fluid for several days, killing 99.99% of the most commonly identified clinical isolates of gram-positive and gram-negative bacteria, along with prevalent fungal strains.

Michael Schurr, MD, Chair of General Surgery at Mission Hospitals in Asheville, NC and co-founder of the company commented, “This will be the first wound dressing in the world with silver and lidocaine together. Along with reducing the incidence of wound infections, this dressing could provide temporary pain relief in some of the most painful wounds, potentially reducing the need for both systemic antibiotics and opioids. This is a major breakthrough in wound management and is poised to significantly enhance the quality of care for patients living with painful wounds.”

“Last year, more than 100,000-unit applications of Microlyte® Matrix were used in wounds,” said Dr. Agarwal. “This next-gen version of Microlyte® Matrix, combining silver and lidocaine, strengthens our commitment to advancing wound care standards and reassures clinicians to choose Microlyte® as their preferred synthetic wound matrix in the protocols of wound management.”

The new Microlyte® Ag/Lidocaine matrix will launch at the Symposium for Advanced Wound Care in May 2025.

About Imbed Biosciences

Imbed Biosciences is a privately held medical device company developing and commercializing innovative solutions to improve wound care. The company has a portfolio of products on the market and in development to combat local pain and infections in complex wounds using its patented Microlyte® Matrix technology platform. For more information, visit ImbedBio.com and connect with us on LinkedIn, X and Facebook.

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"Along with reducing the incidence of wound infections, Microlyte® Ag/Lidocaine could provide temporary pain relief in some of the most painful wounds, potentially reducing the need for both systemic antibiotics and opioids" - Michael Schurr, MD, Imbed CMO