FDA clears first antimicrobial wound dressing with integrated lidocaine for painful wounds

The FDA has issued a 510(k) clearance to Imbed Biosciences to market Microlyte Ag/Lidocaine for the management of painful skin wounds, the company announced in a press release.

This clearance makes Microlyte Ag/Lidocaine the first antimicrobial wound dressing to integrate lidocaine in this indication, the release said.

“The Microlyte Ag/Lidocaine is anticipated to become the standard of care for painful wound management,” Ankit Agarwal, PhD, co-founder and chief scientific officer of Imbed Biosciences, told Healio. “As a ‘no-touch’ dressing, it can be applied directly to the wound, where it adheres instantly, ensuring a sterile environment and reducing infection risk. Its embedded antimicrobial and anesthetic properties may also lessen the need for systemic medications, thus avoiding potential side effects (and treatment for those effects), drug resistance and dependencies, while ultimately lowering health care costs.”

According to the release, more than 8 million Americans suffer from chronic wounds, approximately 60% of which remain unhealed. Microlyte Ag/Lidocaine facilitates wound healing by suppressing 99.99% of the most common microbial growth that encounters the dressing and maintaining an environment that enables cellular regeneration. The addition of lidocaine makes this process less painful for patients.

The dressing uses 40 mg of lidocaine hydrochloride USP per 100 cm2 of wound surface area and can treat both partial- and full-thickness wounds, including venous stasis ulcers, pressure sores, ischemic ulcers, partial thickness burns, donor site wounds, surgical wounds, post-surgical incisions, abrasions and lacerations.

The company plans to launch the product at the Symposium for Advanced Wound Care in May 2025, according to the release.

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