Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance for Microcyn(R)-based Wound Care Hydrogel
Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance for Microcyn(R)-based Wound Care Hydrogel
"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."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.
科羅拉多州博爾德/ACCESSWIRE/2024年11月11日/sonoma pharmaceuticals公司（納斯達克：SNOA），作爲全球醫療保健領導者，開發和生產基於專利Microcyn技術的穩定次氯酸（HOCl）產品，可用於廣泛的應用，包括傷口護理、眼部、口腔和鼻部護理、皮膚病、足病學和動物醫療保健，今天宣佈其Microcyn技術基礎的羥基凝膠獲得了美國食品和藥品管理局（FDA）的新510（k）清關。此次清關包括改進的生物相容性和延長的貨架壽命。
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.
根據這項新的清關，sonoma的Microdacyn羥基凝膠可以在醫護專業人員監督下用於管理與皮膚刺激、瘡瘍、傷害和皮膚組織潰瘍相關的傷口，用於一度和二度燒傷以及糖尿病性潰瘍，並用於機械或手術脫膜的傷口管理。還可以用於場外交易的輕微皮膚刺激、撕裂傷口、磨損傷口和輕微燒傷，包括用於管理因日曬而引起的刺激。
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.
新的510（k）清關流程還包括更嚴格的生物相容性測試，此清關適用於50毫升瓶，貨架壽命爲24個月。
"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."
sonoma首席執行官艾米·特龍布利表示：「這次來自FDA的新510（k）清關證明了sonoma傷口護理產品的卓越安全性和功效。我們基於Microcyn技術的羥基凝膠對於傷口和皮膚刺激的管理是有效的，我們很高興看到它已通過FDA所要求的更嚴格測試。我們對創新的承諾和爲產品設定的高標準使我們在行業中獨具特色。」
About Sonoma Pharmaceuticals, Inc.
關於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 . For partnership opportunities, please contact busdev@sonomapharma.com.
Sonoma Pharmaceuticals是一家全球醫療保健領導者，爲廣泛的應用領域（包括傷口護理、眼科、口腔和鼻部護理、皮膚病狀、足病和動物保健等）開發和生產穩定的次氯酸（HOCl）產品和無毒消毒劑。Sonoma的產品經臨床證明能夠安全地減輕瘙癢、疼痛、瘢痕和刺激，而不會損傷健康組織。HOCl的體外和臨床研究表明，它能夠安全地管理皮膚破損、撕裂、輕微刺激、切口以及完好的皮膚。Sonoma的產品在全球55個國家直接銷售或通過夥伴銷售，公司同時尋求新的分銷夥伴。公司總部設在科羅拉多的博爾德市，製造業務位於墨西哥瓜達拉哈拉，歐洲營銷和銷售業務總部設在荷蘭羅爾蒙德。可以在sonomapharma.com獲得更多信息。如有合作機會，請聯繫busdev@sonomapharma.com。
Forward-Looking Statements
前瞻性聲明
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.
本新聞稿中除歷史信息外，其他事項均爲Sonoma Pharmaceuticals公司及其子公司（以下簡稱公司）內在"安全港"規定下前瞻性聲明，包括有關公司商業和技術進展以及未來財務業績的聲明。這些新聞稿中的前瞻性聲明使用諸如「繼續」、「發展」、「預計」和「擴大」等詞語來識別。本新聞稿中的前瞻性聲明受到公司業務所固有的某些風險和不確定性的影響，這些風險和不確定性可能會導致實際結果發生變化，包括監管臨床和指南開發可能會發生變化、科學數據可能無法滿足監管標準或獲得所需的監管清關或批准、臨床結果可能無法在實際的患者環境中得到複製、公司專利和專利申請所提供的保護可能會受到競爭對手的挑戰、作爲預期的市場，公司產品面臨的市場不會像預期的那麼大，公司產品將無法滲透到一個或多個目標市場、收入不足以滿足公司的現金需求、資金進一步發展以及不同的國家和地區之間多種多樣的監管和營銷要求等等。公司不承擔更新這些前瞻性聲明的任何義務，除非法律要求。
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.
Sonoma Pharmaceuticals和Microcyn是sonoma pharmaceuticals股份有限公司的商標或註冊商標。所有其他商標和服務標記均爲其各自所有者的財產。
Media and Investor Contact:
媒體和投資者聯繫方式:
Sonoma Pharmaceuticals, Inc.
ir@sonomapharma.com
Sonoma Pharmaceuticals，Inc。
ir@sonomapharma.com
Follow us on LinkedIn:
關注我們的Linkedin:
Follow us on Instagram:
關注我們的Instagram:
Follow us on Facebook:
在Facebook上關注我們：
SOURCE: Sonoma Pharmaceuticals, Inc.
來源：Sonoma Pharmaceuticals，Inc。
譯文內容由第三人軟體翻譯。
