PowerHeal™, a bioelectric bandage cleared by the Food and Drug Administration (FDA) for over-the-counter (OTC) use for wound management, has been made available by Vomaris.
PowerHeal is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, and blisters and is available in a variety of sizes. Embedded in the polyester dressing are microcell batteries made of elemental silver and zinc, which generate microcurrents when activated by a conductive medium (eg, wound exudate, water-based wound hydrogels, saline, or water). This technology is expected to accelerate wound healing and minimize the risk of infection.
The FDA clearance was based on multiple clinical trials that demonstrated the effectiveness of the bioelectric bandage, including a randomized, controlled study (ClinicalTrials.gov Identifier: NCT04079998) that compared the wireless electroceutical dressing (WED) to standard of care treatment (eg, debridement, negative pressure wound therapy, skin grafting) in 38 patients with burn wounds.
Findings showed the use of WED significantly reduced or prevented biofilm infection vs standard of care dressing (P < .05). Among the 25 wounds treated with WED, 52% were observed to have little to no biofilm.
“PowerHeal is proud to bring medical-grade wound care technology directly into the hands of consumers,” said Michael Nagel, President & CEO of Vomaris Innovations, Inc. “Our bioelectric products are designed to empower people to take charge of their healing by delivering fast, safe, and effective advanced wound care at home.”
PowerHeal bioelectric bandages are available with or without an adhesive and range in price from $5 to $14 per bandage. The product is available for purchase at powerhealwounds.com and on Amazon.
A prescription version of the antimicrobial wound dressing, known as Procellera, is also available for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc.
References:
- PowerHeal™ revolutionizes wound care with introduction of world’s first and only bioelectric bandage for over-the-counter use. News release. Vomaris. April 16, 2024. https://www.prnewswire.com/news-releases/powerheal-revolutionizes-wound-care-with-introduction-of-worlds-first-and-only-bioelectric-bandage-for-over-the-counter-use-302117303.html.
- US Food and Drug Administration. FDA letter: Vomaris Wound Care, Inc/Re: K180533. Trade/Device Name: Procellera Composite Antibacterial Wound Dressing. December 10, 2018. Accessed April 16, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180533.pdf.
- Chan RK, Nuutila K, Mathew-Steiner SS, et al. A prospective, randomized, controlled study to evaluate the effectiveness of a fabric-based wireless electroceutical dressing compared to standard-of-care treatment against acute trauma and burn wound biofilm infection. Advances in Wound Care. Published online November 3, 2023. doi:10.1089/wound.2023.0007