Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance with Expanded Indications for Over-the-Counter Microcyn(R)-Based Solution

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[{"type":"text","content":"BOULDER, CO / ACCESSWIRE / September 17, 2024 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Microcyn technology-based solution, including specific over-the-counter indications for the face, eyelid and eyelashes.Per this new clearance, Sonoma's Microcyn wound care solution can be used for OTC management of minor skin abrasions, lacerations and irritations, and intact skin on the face, eyelid and eyelashes. Sonoma believes these are the strongest OTC eye care claims in the HOCl industry. Additionally, the new claim referencing the face will expand how Sonoma can market its OTC dermatology products.To support this 510(k) clearance, Sonoma was able to demonstrate safety, efficacy and stability for the 2 ounce product size, offering Sonoma a new opportunity to package certain of its products in smaller sizes appealing to consumers.\"These new extended claims exemplify Sonoma's leadership in developing products based on hypochlorous acid technology under its Microcyn brand. Our new claims around the face, eyelid and eyelash will allow us to further develop industry-leading products to treat common conditions,\" said Amy Trombly, CEO of Sonoma. \"The FDA review process requires increasingly rigorous biocompatibility and performance testing. The expanded indications validate our unparalleled proprietary technology and expertise developed over two decades of working with HOCl as well as our commitment to innovation.\"About Sonoma Pharmaceuticals, Inc.Sonoma Pharmaceuticals is a global healthcare leader for developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound, eye, oral and nasal care, dermatological conditions, podiatry, animal health care and non-toxic disinfectants. Sonoma's products are clinically proven to reduce itch, pain, scarring, and irritation safely and without damaging healthy tissue. In-vitro and clinical studies of HOCl show it to safely manage skin abrasions, lacerations, mino...

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