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.
科罗拉多州博尔德/ACCESSWIRE/2024年11月11日/索诺玛制药公司（纳斯达克股票代码：SNOA）是一家全球医疗保健领导者，开发和生产基于Microcyn技术的专利稳定次氯酸（HOCl）产品，其应用范围广泛，包括伤口护理、眼部、口腔和鼻腔护理、皮肤病、足病和动物保健，今天宣布已收到新的510（k) 其基于 Microcyn 技术的水凝胶已获得美国食品药品监督管理局 (FDA) 的批准，包括改进的生物相容性和延长保质期生命。
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.
根据这项新的许可，索诺玛的Microdacyn Hydrogel可以在医疗保健专业人员的监督下用于治疗与皮肤刺激、溃疡、损伤和皮肤组织溃疡相关的伤口，用于一度和二度烧伤和糖尿病溃疡，以及用于机械或手术清创伤的管理。它还适用于轻微的皮肤刺激、割伤、擦伤和轻度烧伤，包括用于治疗晒伤引起的刺激。
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）许可程序还包括更严格的生物相容性测试，该许可适用于保质期为24个月的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."
索诺玛首席执行官艾米·特隆布利说：“美国食品药品管理局新的510（k）许可表明了索诺玛伤口护理产品的卓越安全性和有效性。”“我们基于Microcyn技术的水凝胶可有效管理伤口和皮肤刺激，我们很高兴看到它已通过美国食品药品管理局要求的更严格的测试。我们对创新的承诺和为产品设定的高标准使我们在行业中脱颖而出。”
About Sonoma Pharmaceuticals, Inc.
关于索诺玛制药公司
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.
索诺玛制药是全球医疗保健领导者，开发和生产稳定的次氯酸（HOCl）产品，其应用范围广泛，包括伤口、眼睛、口腔和鼻腔护理、皮肤病、足病学、动物保健和无毒消毒剂。经临床证明，索诺玛的产品可以安全地减轻瘙痒、疼痛、疤痕和刺激，不会损坏健康组织。HOCl 的体外和临床研究表明，它可以安全地管理皮肤擦伤、割伤、轻微刺激、割伤和皮肤完好无损。索诺玛的产品直接或通过合作伙伴在全球55个国家销售，该公司积极寻找新的分销合作伙伴。该公司的总部位于科罗拉多州的博尔德，制造业务位于墨西哥瓜达拉哈拉。欧洲的营销和销售总部位于荷兰鲁尔蒙德。更多信息可以在以下网址找到。如需合作机会，请联系 busdev@sonomapharma.com。
Forward-Looking Statements
前瞻性陈述
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.
除此处的历史信息外，根据1995年《私人证券诉讼改革法》的 “安全港” 条款，包括有关索诺玛制药公司及其子公司（“公司”）商业和技术进步以及未来财务业绩的陈述，本新闻稿中列出的事项均具有前瞻性。这些前瞻性陈述是通过使用 “继续”、“发展”、“预测”、“期望” 和 “扩大” 等词语来识别的。本新闻稿中的前瞻性陈述受公司业务固有的某些风险和不确定性的影响，这些风险和不确定性可能导致实际业绩发生变化，包括监管临床和指南的制定可能发生变化、科学数据可能不足以满足监管标准或无法获得所需的监管许可或批准、临床结果可能无法在实际患者环境中复制、公司专利和专利申请提供的保护可能会受到质疑、失效或规避的风险其竞争对手，公司产品的可用市场将不会像预期的那么大，公司的产品将无法渗透到一个或多个目标市场，收入将不足以满足公司的现金需求，为进一步发展提供资金，以及与 COVID-19 疫情和经济发展相关的不确定性，不同的产品配方以及不同国家和城市的多种不同的监管和营销要求以及不时详述的其他风险公司向其提交的文件证券交易委员会。除非法律要求，否则公司不承担任何更新这些前瞻性陈述的义务。
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.
索诺玛制药和Microcyn是索诺玛制药公司的商标或注册商标。所有其他商标和服务标志均为其各自所有者的财产。
Media and Investor Contact:
媒体和投资者联系人：
Sonoma Pharmaceuticals, Inc.
ir@sonomapharma.com
索诺玛制药有限公司
ir@sonomapharma.com
Follow us on LinkedIn:
在 LinkedIn 上关注我们：
Follow us on Instagram:
在 Instagram 上关注我们：
Follow us on Facebook:
在脸书上关注我们：
SOURCE: Sonoma Pharmaceuticals, Inc.
来源：索诺玛制药公司
