Imbed Biosciences has received US Food and Drug Administration (FDA) 510(k) clearance for Microlyte Ag/Lidocaine, a wound dressing technology.
Microlyte Ag/Lidocaine is said to be the first antimicrobial wound dressing that combines lidocaine to relieve painful skin wounds.
It uses Imbed’s patented synthetic matrix to deliver ionic and metallic silver with lidocaine, offering antimicrobial protection and local anaesthetic effects.
The dressing releases 40mg of lidocaine hydrochloride USP per 100cm² of the wound area, equivalent to a 4% w/w gel, the medical device company said.
The advanced wound dressing is indicated for managing various partial- and full-thickness wounds. This includes venous stasis ulcers, pressure sores, ischemic ulcers, partial thickness burns, donor site wounds, surgical wounds, post-surgical incisions, abrasions, and lacerations.
Microlyte Ag/Lidocaine supports wound healing progression in deteriorating wounds. It suppresses microbial growth in contact with the dressing, maintains a moist environment for cellular growth, and releases lidocaine for local anaesthetic pain relief.
Imbed Biosciences co-founder and chief scientific officer Ankit Agarwal said: “Our patented polymeric matrix architecture incorporates both silver and lidocaine in the dressing enabling the two active ingredients to provide both antimicrobial and anaesthetic benefits locally to the patient.
“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.”
Additionally, the fully synthetic antimicrobial wound matrix with lidocaine offers sustained antimicrobial activity in simulated wound fluid for several days.
Imbed Biosciences said the technology kills 99.99% of common clinical isolates of gram-positive and gram-negative bacteria, and prevalent fungal strains.
University of Wisconsin–Madison spinoff, Imbed Biosciences is focused on new wound care solutions. The firm develops and commercialises products for reducing local pain and infections in complex wounds.
Its offerings utilise the patented Microlyte Matrix technology platform.
In late 2021, Imbed Biosciences received an $800,000 National Institute for Arthritis and Musculoskeletal and Skin Diseases (NIAMS) grant for developing a wound dressing that targets bacteria in biofilms.
