The Albany Gazette - Sonoma Pharmaceuticals Receives FDA 510(k) Clearance Expanding Indications and Packaging Options for Microdacyn(R) Wound Irrigation Solution

Under this new clearance, Microdacyn Wound Irrigation Solution can be used under the supervision of a healthcare professional for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms from exudating and/or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post‑surgical wounds, first and partial thickness second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites, and for moistening and lubricating absorbent wound dressings.

Microdacyn Wound Irrigation Solution can also be used for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.

The new 510(k) clearance expands the use case to single patient, multiple use.

The 510(k) also adds new packaging configurations, including 4 oz, 8 oz, 16 oz, and 34 oz PET bottles with a polypropylene flip-top cap, and a 4 oz PET bottle with polypropylene sprayer or spray gun, each with a 24-month shelf life.

"This expanded FDA clearance is another example of how we continue to strengthen the value of our Microcyn technology platform," said Amy Trombly, CEO of Sonoma Pharmaceuticals. "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."

About Sonoma Pharmaceuticals, Inc.

Sonoma Pharmaceuticals is a global healthcare company specializing in stabilized hypochlorous acid (HOCl) technology for medical, veterinary and consumer healthcare applications. With decades of expertise in HOCl formulation, manufacturing and regulatory science, Sonoma helps healthcare companies develop, manufacture and commercialize innovative products through contract development, regulatory support and commercial manufacturing.

The company's patented Microcyn^® technology platform supports a broad range of applications, including wound care, burn care, dermatology, senior and baby care, podiatry, eye care, oral care and animal health. Sonoma's regulatory portfolio includes 23 FDA 510(k) clearances, along with product registrations and approvals in markets around the world, providing commercial partners with an established pathway to market.

Headquartered in Boulder, Colorado, Sonoma operates a high-capacity manufacturing facility in Guadalajara, Mexico, and European commercial headquarters in Roermond, Netherlands. The company supports commercial partners in more than 55 countries and is actively expanding its global partner network.

For partnership opportunities, including contract development, licensing, commercial manufacturing and distribution, please contact [email protected]. More information is available at www.sonomapharma.com.

Forward-Looking Statements

Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries (the "company"). These forward-looking statements are identified by the use of words such as "continue," "develop," "anticipate," "expect" and "opportunities," among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the company's products will not be as large as expected, the company's products will not be able to penetrate one or more targeted markets, and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. The company disclaims any obligation to update these forward-looking statements, except as required by law.

Sonoma Pharmaceuticals™, Microcyn^® and Microdacyn^® are trademarks or registered trademarks of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners.

Media and Investor Contact:
Sonoma Pharmaceuticals, Inc.
[email protected]

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SOURCE: Sonoma Pharmaceuticals, Inc.

View the original press release on ACCESS Newswire

(A.Johnson--TAG)