FDA Clears Imbed Biosciences’ Microlyte Ag/ Lidocaine

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 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.

Microlyte Ag/Lidocaine uses 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.

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

Microlyte Ag/Lidocaine is designed to facilitate wound healing 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.

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.”

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