Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance for Microcyn(R)-based Wound Care Hydrogel

BOULDER, CO / ACCESSWIRE / November 11, 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 hydrogel, including improved biocompatibility and extended shelf life.

Per this new clearance, Sonoma's Microdacyn Hydrogel can be used under the supervision of a healthcare professional for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue, for use on first and second degree burns, and diabetic ulcers, and for the management of mechanically or surgically debrided wounds. It is also indicated for OTC use on minor skin irritations, lacerations, abrasions and minor burns, including for the management of irritation from sunburn.

The new 510(k) clearance process also included more rigorous biocompatibility testing, and the clearance applies to 50mL bottles with a shelf life of 24 months.

"This new 510(k) clearance from the FDA demonstrates the superior safety and efficacy of Sonoma's wound care products," said Amy Trombly, CEO of Sonoma. "Our Microcyn technology-based hydrogel is effective for the management of both wounds and skin irritations, and we are pleased to see it has passed the more rigorous testing required by the FDA. Our commitment to innovation and the high standards we set for our products sets us apart in the industry."

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, minor irritations, cuts, and intact skin. Sonoma's products are sold either directly or via partners in 55 countries worldwide and the company actively seeks new distribution partners. The company's principal office is in Boulder, Colorado, with manufacturing operations in Guadalajara, Mexico. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.sonomapharma.com. For partnership opportunities, please contact [e-mail].

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