Sonoma Pharmaceuticals and MicroSafe Group Announce that Nanocyn(R) Disinfectant & Sanitizer has been Approved by the Australian TGA as Effective Against Candida auris and C-Diff

Rhea-AI Summary

Sonoma Pharmaceuticals (Nasdaq: SNOA) and MicroSafe Group announce that the Australian Therapeutic Goods Administration (TGA) has approved extended claims for Nanocyn® Disinfectant and Sanitizer. The product, manufactured by Sonoma using its patented Microcyn® technology, is now approved for use against Candida auris (C. auris) and Clostridium difficile (C. diff) with a 10-minute kill time.

Previously, Nanocyn® was approved with a 15-second kill time against SARS-CoV-2 and a 30-second kill time against Norovirus, Influenza A (H1N1), and bacteria like MRSA. The U.S. EPA has also approved Nanocyn® as an effective disinfectant against various pathogens. This extended approval highlights Nanocyn®'s broad-spectrum efficacy and its potential to enhance patient safety in healthcare settings.

Positive

• Extended TGA approval for Nanocyn® against C. auris and C. diff
• Broad-spectrum efficacy against multiple pathogens
• Rapid kill times (15-30 seconds) for various bacteria and viruses
• U.S. EPA approval as an effective disinfectant

Negative

• Longer kill time (10 minutes) for C. auris and C. diff compared to other pathogens

Insights

Medical Research Analyst

The TGA's approval of Nanocyn® Disinfectant and Sanitizer for use against Candida auris and Clostridium difficile is a significant development in infection control. This expands the product's utility in healthcare settings, particularly for combating hospital-acquired infections. The 10-minute kill time for these pathogens is competitive, though not exceptional. The product's broad-spectrum efficacy, including against SARS-CoV-2, Norovirus and MRSA, enhances its value proposition. However, it's important to note that while effective, Nanocyn® is not a silver bullet and should be part of a comprehensive infection control strategy.

Market Research Analyst

This regulatory approval could potentially boost Sonoma Pharmaceuticals' market position in Australia and globally. The expanded claims for Nanocyn® against C. auris and C. diff address critical needs in healthcare facilities, potentially driving demand. However, the impact on revenue remains uncertain without sales projections or market size data. The partnership with MicroSafe Group for distribution is noteworthy, but its terms and potential impact on Sonoma's financials are unclear. Investors should monitor how this approval translates into market penetration and revenue growth in upcoming quarters.

Financial Analyst

While this regulatory approval is positive news for Sonoma Pharmaceuticals (NASDAQ: SNOA), its financial impact remains uncertain. The company's stock may see a short-term boost, but long-term value depends on successful commercialization. Sonoma's market cap of $3.92 million and revenue of $10.97 million (TTM) suggest it's a small player in the pharmaceutical industry. The expanded approval could help increase market share, but investors should watch for concrete sales figures in future earnings reports. The lack of financial projections in this announcement limits our ability to quantify the potential impact on Sonoma's bottom line.

BOULDER, CO / ACCESSWIRE / August 26, 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, and its partner, the MicroSafe Group DMCC, announce that the Australian Therapeutic Goods Administration (TGA) has approved extended claims for Nanocyn^® Disinfectant and Sanitizer, which is manufactured by Sonoma for its partner MicroSafe using Sonoma's patented Microcyn^® technology.

Nanocyn^® was previously approved by the TGA and entered into The Australian Register of Therapeutic Goods with a 15 second kill time against SARS-CoV-2 (COVID 19), and a 30 second kill time against Norovirus (Gastro), Influenza A (H1N1), and bacteria, such as Staphylococcus aureus (MRSA), E. coli, Pseudomonas aeruginosa. The TGA has now also approved Nanocyn® for use against Candida auris (C. auris) and Clostritium Difficile (C. diff.) in ten minutes.

The U.S. Environmental Protection Agency (EPA) has previously approved Nanocyn^® as an effective bactericidal (MRSA, Salmonella), virucidal (Mpox, SARS-CoV-2), and fungicidal disinfectant for use on pre-cleaned, hard, non-porous surfaces.

"The MicroSafe Group is proud to have Nanocyn^®'s effectiveness further validated by the TGA, especially against critical pathogens like C. auris and C. difficile," said Safa Qadumi, CEO of MicroSafe Group. These claims highlight Nanocyn^®'s rapid, non-toxic disinfection capabilities, providing hospitals and other settings with a safe and effective solution to combat harmful infections and enhance patient safety," Mrs. Qadumi added.

"We are excited to obtain these additional claims from the Australian TGA, as we continue to make advancements as a broad-use technology against harmful bacteria, viruses and fungi, while meeting high safety standards," said Amy Trombly, CEO of Sonoma Pharmaceuticals. "According to the CDC, C. auris can cause severe multidrug-resistant illness in hospitalized patients, and C. diff causes inflammation of the colon and can be life-threatening. Our Microcyn technology creates a safer environment for all patients."

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 busdev@sonomapharma.com.

About MicroSafe Group DMCC

The MicroSafe Group has operations in several international countries with its head office in Dubai, United Arab Emirates. With regional offices in the Middle East, as well as MicroSafe Care Australia, MicroSafe Group is providing innovative solutions to a wide range of industries and healthcare providers. The MicroSafe Group promotes only those products it believes will truly revolutionize healthcare - products that will enrich the lives of patients and healthcare professionals all over the world. Interested distributors for Europe, West Asia and North Africa may contact Safwan Abdallah, COO of MicroSafe Group at info@microsafecare.com. For Australia please contact MicroSafe Australia's Managing Director Matt Seifert, at info@microsafe.com.au. More information can be found at www.microsafe.com and www.microsafe.com.au.

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 "expand," 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, revenues will not be sufficient to meet the company's cash needs, fund further development, as well as uncertainties relative to the COVID-19 pandemic and economic development, varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, 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™ and Microcyn^® are trademarks or registered trademarks of Sonoma Pharmaceuticals, Inc. Nanocyn^® is a registered trademark of MicroSafe Group DMCC. All other trademarks and service marks are the property of their respective owners.

Media and Investor Contact:

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SOURCE: Sonoma Pharmaceuticals, Inc.

View the original press release on accesswire.com

FAQ

What new approvals did Nanocyn® Disinfectant and Sanitizer receive from the Australian TGA?

The Australian TGA approved Nanocyn® for use against Candida auris (C. auris) and Clostridium difficile (C. diff) with a 10-minute kill time.

What is the kill time for Nanocyn® against SARS-CoV-2 according to the TGA approval?

Nanocyn® has a 15-second kill time against SARS-CoV-2 (COVID-19) according to the TGA approval.

Has Nanocyn® been approved by regulatory bodies other than the Australian TGA?

Yes, the U.S. Environmental Protection Agency (EPA) has approved Nanocyn® as an effective bactericidal, virucidal, and fungicidal disinfectant for use on pre-cleaned, hard, non-porous surfaces.

What is Sonoma Pharmaceuticals' stock symbol?

Sonoma Pharmaceuticals' stock symbol is SNOA, and it is listed on the Nasdaq.