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/索諾瑪製藥公司（納斯達克股票代碼：SNOA）是一家全球醫療保健領導者，開發和生產基於Microcyn技術的專利穩定次氯酸（HOCl）產品，其應用範圍廣泛，包括傷口護理、眼部、口腔和鼻腔護理、皮膚病、足病和動物保健，今天宣佈已收到新的510（k) 其基於 Microcyn 技術的水凝膠已獲得美國食品藥品監督管理局 (FDA) 的批准，包括改進的生物相容性和延長保質期生命。
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.
根據這項新的許可，索諾瑪的Microdacyn Hydrogel可以在醫療保健專業人員的監督下用於治療與皮膚刺激、潰瘍、損傷和皮膚組織潰瘍相關的傷口，用於一度和二度燒傷和糖尿病潰瘍，以及用於機械或手術清創傷的管理。它還適用於輕微的皮膚刺激、割傷、擦傷和輕度燒傷，包括用於治療曬傷引起的刺激。
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）許可程序還包括更嚴格的生物相容性測試，該許可適用於保質期爲24個月的50mL瓶子。
"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."
索諾瑪首席執行官艾米·特隆布利說：「美國食品藥品管理局新的510（k）許可表明了索諾瑪傷口護理產品的卓越安全性和有效性。」「我們基於Microcyn技術的水凝膠可有效管理傷口和皮膚刺激，我們很高興看到它已通過美國食品藥品管理局要求的更嚴格的測試。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脫穎而出。」
About Sonoma Pharmaceuticals, Inc.
關於索諾瑪製藥公司
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.
索諾瑪製藥是全球醫療保健領導者，開發和生產穩定的次氯酸（HOCl）產品，其應用範圍廣泛，包括傷口、眼睛、口腔和鼻腔護理、皮膚病、足病學、動物保健和無毒消毒劑。經臨床證明，索諾瑪的產品可以安全地減輕瘙癢、疼痛、疤痕和刺激，不會損壞健康組織。HOCl 的體外和臨床研究表明，它可以安全地管理皮膚擦傷、割傷、輕微刺激、割傷和皮膚完好無損。索諾瑪的產品直接或通過合作伙伴在全球55個國家銷售，該公司積極尋找新的分銷合作伙伴。該公司的總部位於科羅拉多州的博爾德，製造業務位於墨西哥瓜達拉哈拉。歐洲的營銷和銷售總部位於荷蘭魯爾蒙德。更多信息可以在以下網址找到。如需合作機會，請聯繫 busdev@sonomapharma.com。
Forward-Looking Statements
前瞻性陳述
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.
除此處的歷史信息外，根據1995年《私人證券訴訟改革法》的 「安全港」 條款，包括有關索諾瑪製藥公司及其子公司（「公司」）商業和技術進步以及未來財務業績的陳述，本新聞稿中列出的事項均具有前瞻性。這些前瞻性陳述是通過使用 「繼續」、「發展」、「預測」、「期望」 和 「擴大」 等詞語來識別的。本新聞稿中的前瞻性陳述受公司業務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導致實際業績發生變化，包括監管臨床和指南的制定可能發生變化、科學數據可能不足以滿足監管標準或無法獲得所需的監管許可或批准、臨床結果可能無法在實際患者環境中複製、公司專利和專利申請提供的保護可能會受到質疑、失效或規避的風險其競爭對手，公司產品的可用市場將不會像預期的那麼大，公司的產品將無法滲透到一個或多個目標市場，收入將不足以滿足公司的現金需求，爲進一步發展提供資金，以及與 COVID-19 疫情和經濟發展相關的不確定性，不同的產品配方以及不同國家和城市的多種不同的監管和營銷要求以及不時詳述的其他風險公司向其提交的文件證券交易委員會。除非法律要求，否則公司不承擔任何更新這些前瞻性陳述的義務。
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.
索諾瑪製藥和Microcyn是索諾瑪製藥公司的商標或註冊商標。所有其他商標和服務標誌均爲其各自所有者的財產。
Media and Investor Contact:
媒體和投資者聯繫人：
Sonoma Pharmaceuticals, Inc.
ir@sonomapharma.com
索諾瑪製藥有限公司
ir@sonomapharma.com
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SOURCE: Sonoma Pharmaceuticals, Inc.
來源：索諾瑪製藥公司
