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

Sonoma Pharmaceuticals (NASDAQ:SNOA) received new FDA 510(k) clearance for its Microdacyn® Wound Irrigation Solution, expanding indications, use, and packaging.

Rhea-AI Summary

Sonoma Pharmaceuticals (NASDAQ:SNOA) received new FDA 510(k) clearance for its Microdacyn® Wound Irrigation Solution, expanding indications, use, and packaging.

The solution is now cleared for broader professional wound applications, OTC minor skin issues, single‑patient multiple use, and new PET bottle sizes with a 24‑month shelf life.

Positive

• FDA 510(k) clearance expands Microdacyn professional wound care indications
• Product cleared for OTC use on minor abrasions, lacerations and facial skin
• Authorization for single patient, multiple use increases flexibility of use
• New PET bottle sizes from 4 oz to 34 oz broaden packaging options
• All new configurations carry a 24‑month shelf life
• Management highlights clearance as support for long‑term growth strategy

Negative

• None.

Market Context

This announcement adds broader FDA 510(k) indications, multiple-use labeling and a 24-month shelf li...

Analysis

This announcement adds broader FDA 510(k) indications, multiple-use labeling and a 24-month shelf life to Microdacyn, reinforcing Sonoma’s HOCl wound-care platform. Investors may track how new OTC uses and packaging translate into revenue given international reliance and customer concentration.

Key Figures

Shelf life: 24-month shelf life FDA 510(k) clearances: 22 clearances R&D expenses 2026: $2,271,000 +5 more

Shelf life

24-month shelf life

Microdacyn wound irrigation packaging configurations

FDA 510(k) clearances

22 clearances

Total FDA 510(k) clearances described in 10-K

R&D expenses 2026

$2,271,000

Year ended March 31, 2026

R&D expenses 2025

$1,814,000

Year ended March 31, 2025

International revenue mix

71% of revenue

Portion of 2026 revenue from outside the U.S.

Customer concentration

15% of net revenues

Customer C share of 2026 net revenues

Countries served

Over 55 countries

Global sales footprint described in 10-K

Public float

$12,649,011

Reported float as of April 20, 2026 in 424B5

Historical Context

5 past events · Latest: Jun 16

5 events

1. Jun 16

   Earnings results

   24h Move

   +4.5%

   Strong FY and Q4 revenue growth with narrowed losses versus prior year.

2. Apr 24

   Equity offering

   24h Move

   -36.7%

   $4M public offering of stock and warrants at $1.35 per share.

3. Mar 24

   Retail product launch

   24h Move

   -8.2%

   Launch of HOCl burn relief hydrogel in CVS and Walmart stores.

4. Mar 18

   New product line

   24h Move

   +2.9%

   Introduction of Aquanil AD HOCl dermatology line for sensitive skin.

5. Feb 10

   Earnings results

   24h Move

   +1.4%

   Q3 revenue and margins improved with strong U.S. growth and lower losses.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

hypochlorous acid, hocl, 510(k) clearance, debridement

4 terms

hypochlorous acid medical

"a global healthcare leader in hypochlorous acid (HOCl) technology"

A mild, naturally occurring chemical formed when chlorine dissolves in water that acts as a fast-acting disinfectant and antiseptic. Think of it like a gentle, short-lived version of bleach that kills bacteria and viruses without strong fumes or persistent chemical residue. Investors watch it because demand, regulatory approvals, production capacity and safety perceptions directly affect sales in cleaning, healthcare and water-treatment markets, influencing product lines and revenue.

hocl medical

"a global healthcare leader in hypochlorous acid (HOCl) technology"

Hypochlorous acid (HOCl) is a weak, fast‑acting disinfectant chemical that is produced by the immune system and formulated for use in wound care, surface sanitizers, and medical devices. Investors watch HOCl products because their safety profile, regulatory approvals, and manufacturing scalability determine how widely they can replace harsher cleaners or be adopted in healthcare and consumer markets — think of it as a gentler, quick‑acting sanitizer that can open or close market opportunities.

510(k) clearance regulatory

"announced it has received a new 510(k) clearance from the U.S. Food and Drug Administration"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

debridement medical

"for cleansing, irrigating, moistening, debridement and removal of foreign material"

Debridement is the medical removal of dead, infected, or damaged tissue and foreign material from a wound to promote healing, similar to pruning dead branches so new growth can flourish. For investors, it matters because how debridement is performed — by drugs, devices, dressings, or procedures — affects clinical outcomes, product demand, reimbursement decisions, regulatory approval pathways, and the financial prospects of companies offering those solutions.

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BOULDER, CO / ACCESS Newswire / June 30, 2026 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader in hypochlorous acid (HOCl) technology, today announced it has received a new 510(k) clearance from the U.S. Food and Drug Administration (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 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 busdev@sonomapharma.com. 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.
ir@sonomapharma.com

Website: www.sonomapharma.com
Follow us on LinkedIn: https://www.linkedin.com/company/sonoma-pharmaceuticals
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Follow us on Facebook: https://www.facebook.com/sonomapharma/

SOURCE: Sonoma Pharmaceuticals, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Sonoma Pharmaceuticals (NASDAQ:SNOA) announce about FDA 510(k) clearance on June 30, 2026?

Sonoma Pharmaceuticals announced new FDA 510(k) clearance expanding indications, use, and packaging for Microdacyn Wound Irrigation Solution. According to Sonoma, the clearance broadens professional wound applications, allows single‑patient multiple use, and adds several PET bottle configurations with a 24‑month shelf life.

How does the new FDA 510(k) clearance expand Microdacyn wound care indications for SNOA?

The clearance expands Microdacyn use for cleansing, irrigating, moistening and debriding various acute and chronic dermal lesions. According to Sonoma, this includes Stage I–IV pressure ulcers, stasis ulcers, diabetic ulcers, post‑surgical wounds, certain burns, graft sites, donor sites, and device exit sites.

Is Microdacyn Wound Irrigation Solution now approved for OTC use after the June 2026 FDA decision?

Yes, Microdacyn can now be used OTC for minor skin conditions. According to Sonoma, indications include minor skin abrasions, minor lacerations, minor irritations, and intact skin of the face, eyelid and eyelashes, expanding access beyond supervised clinical wound care settings.

What does single patient, multiple use labeling mean for Sonoma Pharmaceuticals’ Microdacyn product?

Single patient, multiple use labeling allows a Microdacyn bottle to be reused by one patient. According to Sonoma, this expanded use case may improve convenience and product utilization compared with single‑use restrictions, potentially supporting adoption in both clinical and home settings.

What new packaging sizes did Sonoma Pharmaceuticals add for Microdacyn after the FDA 510(k) clearance?

The clearance adds 4 oz, 8 oz, 16 oz, and 34 oz PET bottles with flip‑top caps. According to Sonoma, it also includes a 4 oz PET bottle with sprayer or spray gun, with each configuration having a 24‑month shelf life.

How might the expanded Microdacyn indications affect Sonoma Pharmaceuticals’ commercial partners and distributors?

The broader labeling may create more marketing and clinical use options for partners. According to Sonoma, expanded claims, multiple‑use labeling, and new packaging are intended to provide additional opportunities for commercial partners, distributors, and private‑label customers in wound care markets.