Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance for Microcyn(R)-based Wound Care Hydrogel
Sonoma Pharmaceuticals (NASDAQ:SNOA) has received a new FDA 510(k) clearance for its Microcyn technology-based hydrogel. The clearance includes improved biocompatibility and extended shelf life of 24 months for 50mL bottles. The product can be used professionally for managing wounds, dermal irritation, first and second degree burns, and diabetic ulcers. It's also approved for over-the-counter use on minor skin irritations, lacerations, abrasions, and minor burns, including sunburn management.
Sonoma Pharmaceuticals (NASDAQ:SNOA) ha ricevuto una nuova approvazione 510(k) dalla FDA per il suo idrogelo basato sulla tecnologia Microcyn. L'approvazione include una biocompatibilità migliorata e una durata di conservazione estesa a 24 mesi per le bottiglie da 50 mL. Il prodotto può essere utilizzato professionalmente per la gestione di ferite, irritazioni cutanee, ustioni di primo e secondo grado e ulcere diabetiche. È anche approvato per l'uso da banco su lievi irritazioni cutanee, lacerazioni, abrasioni e lievi ustioni, compresa la gestione delle scottature solari.
Sonoma Pharmaceuticals (NASDAQ:SNOA) ha recibido una nueva autorización 510(k) de la FDA para su hidrogel basado en la tecnología Microcyn. La autorización incluye una mejor biocompatibilidad y una vida útil extendida de 24 meses para botellas de 50 mL. El producto se puede usar profesionalmente para el manejo de heridas, irritaciones dérmicas, quemaduras de primer y segundo grado y úlceras diabéticas. También está aprobado para su uso de venta libre en irritaciones menores de la piel, laceraciones, abrasiones y quemaduras menores, incluida la gestión de quemaduras solares.
소노마 제약(SNASDAQ:SNOA)가 Microcyn 기술 기반의 하이드로젤에 대해 새로운 FDA 510(k) 허가를 받았습니다. 이 허가는 개선된 생체 적합성과 50mL 병의 유통기한을 24개월로 연장하는 내용을 포함합니다. 이 제품은 상처 관리, 피부 자극, 1도 및 2도 화상, 당뇨병성 궤양 관리에 전문적으로 사용할 수 있습니다. 또한 경미한 피부 자극, 상처, 찰과상 및 경미한 화상, 자외선 차단 관리를 위한 일반 판매에도 허가되었습니다.
Sonoma Pharmaceuticals (NASDAQ:SNOA) a reçu une nouvelle autorisation 510(k) de la FDA pour son hydrogel basé sur la technologie Microcyn. Cette autorisation inclut une biocompatibilité améliorée et une durée de conservation prolongée de 24 mois pour les bouteilles de 50 mL. Le produit peut être utilisé professionnellement pour la gestion des plaies, des irritations cutanées, des brûlures de premier et deuxième degré, ainsi que des ulcères diabétiques. Il est également approuvé pour une utilisation en vente libre sur les irritations mineures de la peau, les lacérations, les abrasions et les brûlures mineures, y compris la gestion des coups de soleil.
Sonoma Pharmaceuticals (NASDAQ:SNOA) hat eine neue FDA 510(k) Zulassung für sein auf der Microcyn-Technologie basierendes Hydrogel erhalten. Die Zulassung umfasst eine verbesserte Biokompatibilität und eine verlängerte Haltbarkeit von 24 Monaten für 50mL-Flaschen. Das Produkt kann professionell zur Behandlung von Wunden, Hautirritationen, ersten und zweiten Grades Verbrennungen sowie diabetischen Geschwüren eingesetzt werden. Es ist auch für die Selbstmedikation bei leichten Hautirritationen, Schnittwunden, Abschürfungen und leichten Verbrennungen, einschließlich der Behandlung von Sonnenbrand, zugelassen.
- Received new FDA 510(k) clearance for Microcyn hydrogel
- Extended product shelf life to 24 months
- Expanded usage indications for both professional and OTC applications
- Passed more rigorous biocompatibility testing requirements
- None.
Insights
The FDA's new 510(k) clearance for Sonoma's Microcyn hydrogel represents a significant regulatory milestone with expanded applications and improved specifications. The clearance validates both professional medical use for serious wounds and over-the-counter applications for minor injuries. Key improvements include enhanced biocompatibility testing and a 24-month shelf life, which could strengthen the product's market position.
The expanded indications covering diabetic ulcers, burns and surgical wounds position this product well in the
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 busdev@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 "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. 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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FAQ
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