Sonoma Pharmaceuticals (NASDAQ: SNOA) has received a new 510(k) clearance from the FDA for its Microdacyn Wound Irrigation Solution, including expanded claims, clearance for multiple use, and additional packaging configurations.
Under this new clearance, Microdacyn Wound Irrigation Solution can be used under professional supervision for wound cleansing, irrigation, moistening, debridement, and removal of foreign material and microorganisms, and moistening absorbent wound dressings. The indication includes exudating and/or contaminated wounds, acute and chronic dermal lesions, pressure, stasis, diabetic foot ulcers, postsurgical wounds, first- and partial-thickness second degree burns, abrasions, minor irritations of the skin, ingrown toe nails, graft and donor sites, and exit sites.
In a statement, Amy Trombly, CEO of Sonoma, commented, “This expanded FDA clearance is another example of how we continue to strengthen the value of our Microcyn technology platform. By broadening product claims, adding multiple-use labeling and introducing new packaging options, we are creating additional opportunities for our commercial partners while increasing the attractiveness of our wound care portfolio to prospective distributors and private-label customers. We remain committed to regulatory investment as it provides an important competitive advantage for Sonoma and supports our long-term growth strategy.”
