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
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.
Sonoma Pharmaceuticals (Nasdaq: SNOA) e MicroSafe Group annunciano che l'Australian Therapeutic Goods Administration (TGA) ha approvato ulteriori indicazioni per Nanocyn® Disinfectant and Sanitizer. Il prodotto, fabbricato da Sonoma utilizzando la sua tecnologia brevettata Microcyn®, è ora approvato per l'uso contro Candida auris (C. auris) e Clostridium difficile (C. diff) con un tempo di uccisione di 10 minuti.
In precedenza, Nanocyn® era stato approvato con un tempo di uccisione di 15 secondi contro SARS-CoV-2 e un tempo di 30 secondi contro Norovirus, Influenza A (H1N1) e batteri come MRSA. Anche l'EPA degli Stati Uniti ha approvato Nanocyn® come disinfettante efficace contro vari patogeni. Questa approvazione estesa evidenzia l'ampia efficacia di Nanocyn® e il suo potenziale per migliorare la sicurezza dei pazienti nelle strutture sanitarie.
Sonoma Pharmaceuticals (Nasdaq: SNOA) y MicroSafe Group anuncian que la Administración Australiana de Bienes Terapéuticos (TGA) ha aprobado reclamaciones ampliadas para Nanocyn® Disinfectant and Sanitizer. El producto, fabricado por Sonoma utilizando su tecnología patentada Microcyn®, ahora está aprobado para su uso contra Candida auris (C. auris) y Clostridium difficile (C. diff) con un tiempo de eliminación de 10 minutos.
Anteriormente, Nanocyn® fue aprobado con un tiempo de eliminación de 15 segundos contra SARS-CoV-2 y un tiempo de 30 segundos contra Norovirus, Influenza A (H1N1) y bacterias como MRSA. La EPA de EE. UU. también ha aprobado Nanocyn® como un desinfectante eficaz contra varios patógenos. Esta aprobación ampliada resalta la eficacia de amplio espectro de Nanocyn® y su potencial para mejorar la seguridad del paciente en entornos de atención médica.
소노마 제약(Sonoma Pharmaceuticals, Nasdaq: SNOA)과 마이크로세이프 그룹(MicroSafe Group)은 호주 치료용 의약품 관리청(TGA)이 Nanocyn® Disinfectant and Sanitizer의 확장된 사용을 승인했다고 발표했습니다. 이 제품은 소노마에서 자사의 특허 기술인 마이크로신(Microcyn®)을 사용하여 제조하였으며, 이제 칸디다 오리스(Candida auris, C. auris)와 클로스트리듐 디피실리(C. diff)에 대해 10분 내에 박멸할 수 있는 능력이 승인되었습니다.
이전에는 Nanocyn®이 SARS-CoV-2에 대해 15초, 노로바이러스, 인플루엔자 A(H1N1), 그리고 MRSA와 같은 박테리아에 대해 30초의 작용 시간을 가지고 승인이 있었습니다. 미국 EPA 또한 Nanocyn®을 다양한 병원체에 대한 효과적인 소독제로 승인했습니다. 이러한 확장된 승인은 Nanocyn®의 광범위한 효능과 의료 환경에서 환자 안전성을 높일 수 있는 가능성을 강조합니다.
Sonoma Pharmaceuticals (Nasdaq: SNOA) et MicroSafe Group annoncent que l'Administration australienne des biens thérapeutiques (TGA) a approuvé des indications élargies pour Nanocyn® Disinfectant and Sanitizer. Le produit, fabriqué par Sonoma à l'aide de sa technologie brevetée Microcyn®, est maintenant approuvé pour être utilisé contre Candida auris (C. auris) et Clostridium difficile (C. diff) avec un temps d'élimination de 10 minutes.
Avec l'approbation précédente, Nanocyn® était approuvé avec un temps d'élimination de 15 secondes contre le SARS-CoV-2 et un temps de 30 secondes contre le Norovirus, l'Influenza A (H1N1) et des bactéries comme le MRSA. L'EPA des États-Unis a également approuvé Nanocyn® comme un désinfectant efficace contre divers agents pathogènes. Cette approbation élargie met en avant l'efficacité à large spectre de Nanocyn® et son potentiel pour améliorer la sécurité des patients dans les établissements de santé.
Sonoma Pharmaceuticals (Nasdaq: SNOA) und die MicroSafe Gruppe geben bekannt, dass die Australische Therapeutische Gesundheitsbehörde (TGA) die erweiterten Anwendungsansprüche für Nanocyn® Disinfectant and Sanitizer genehmigt hat. Das Produkt, das von Sonoma unter Verwendung seiner patentierten Microcyn®-Technologie hergestellt wird, ist nun für die Anwendung gegen Candida auris (C. auris) und Clostridium difficile (C. diff) mit einer Abtötungszeit von 10 Minuten zugelassen.
Zuvor war Nanocyn® mit einer Abtötungszeit von 15 Sekunden gegen SARS-CoV-2 und einer von 30 Sekunden gegen Norovirus, Influenza A (H1N1) und Bakterien wie MRSA genehmigt. Auch die EPA der USA hat Nanocyn® als wirksames Desinfektionsmittel gegen verschiedene Krankheitserreger genehmigt. Diese erweiterte Genehmigung hebt die breitere Wirksamkeit von Nanocyn® hervor und dessen Potenzial, die Sicherheit der Patienten im Gesundheitswesen zu erhöhen.
- 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
- Longer kill time (10 minutes) for C. auris and C. diff compared to other pathogens
Insights
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.
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.
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
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.
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SOURCE: Sonoma Pharmaceuticals, Inc.
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