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Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance With Expanded Indications for Over-the-Counter Microcyn(R)-Based Solution

Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance With Expanded Indications for Over-the-Counter Microcyn(R)-Based Solution

sonoma pharmaceuticals收到新的FDA 510(k)清关,扩大了Microcyn(R)基础溶液的非处方药适应症。
Accesswire ·  09/17 08:30

BOULDER, CO / ACCESSWIRE / September 17, 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 solution, including specific over-the-counter indications for the face, eyelid and eyelashes.

科罗拉多州博尔德/ACCESSWIRE/2024年9月17日/ Sonoma Pharmaceuticals,Inc.(纳斯达克:SNOA)是一家全球医疗保健行业的领导者,研发和生产基于专利Microcyn技术的稳定次氯酸(HOCl)产品,应用范围广泛,包括伤口护理,眼部,口腔和鼻腔护理,皮肤病症,足疗和动物保健。今天宣布,Sonoma Pharmaceuticals已从美国食品和药物管理局(FDA)获得基于Microcyn技术的新510(k)许可证,包括针对面部,眼睑和睫毛的特定非处方指示。

Per this new clearance, Sonoma's Microcyn wound care solution can be used for OTC management of minor skin abrasions, lacerations and irritations, and intact skin on the face, eyelid and eyelashes. Sonoma believes these are the strongest OTC eye care claims in the HOCl industry. Additionally, the new claim referencing the face will expand how Sonoma can market its OTC dermatology products.

根据这个新许可,Sonoma的Microcyn伤口护理解决方案可以用于非处方管理面部,眼睑和睫毛上的轻微皮肤擦伤,切口和刺激,以及完整的皮肤。Sonoma认为这些是HOCl行业中最强大的非处方眼部护理声明。此外,涉及面部的新要求将扩大Sonoma在市场上销售非处方皮肤科产品的范围。

To support this 510(k) clearance, Sonoma was able to demonstrate safety, efficacy and stability for the 2 ounce product size, offering Sonoma a new opportunity to package certain of its products in smaller sizes appealing to consumers.

为了支持这个510(k)许可,Sonoma能够为2盎司产品尺寸证明其安全性,疗效和稳定性,为Sonoma提供了一个新的机会,在较小的尺寸中包装其某些产品,以吸引消费者。

"These new extended claims exemplify Sonoma's leadership in developing products based on hypochlorous acid technology under its Microcyn brand. Our new claims around the face, eyelid and eyelash will allow us to further develop industry-leading products to treat common conditions," said Amy Trombly, CEO of Sonoma. "The FDA review process requires increasingly rigorous biocompatibility and performance testing. The expanded indications validate our unparalleled proprietary technology and expertise developed over two decades of working with HOCl as well as our commitment to innovation."

Sonoma的首席执行官Amy Trombly表示:“这些新的扩展声明展示了Sonoma在其Microcyn品牌下基于次氯酸技术开发产品的领导地位。我们关于面部,眼睑和睫毛的新声明将使我们能够进一步开发行业领先的用于治疗常见疾病的产品。”“FDA的审查流程要求越来越严格的相容性和性能测试。扩大的适应症验证了我们无与伦比的专有技术和二十多年的次氯酸研究经验以及我们对创新的承诺。”

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 . For partnership opportunities, please contact busdev@sonomapharma.com.

关于Sonoma Pharmaceuticals, Inc.
Sonoma Pharmaceuticals是一家全球医疗保健领导者,为广泛的应用领域(包括伤口护理、眼科、口腔和鼻部护理、皮肤病状、足病和动物保健等)开发和生产稳定的次氯酸(HOCl)产品和无毒消毒剂。Sonoma的产品经临床证明能够安全地减轻瘙痒、疼痛、瘢痕和刺激,而不会损伤健康组织。HOCl的体外和临床研究表明,它能够安全地管理皮肤破损、撕裂、轻微刺激、切口以及完好的皮肤。Sonoma的产品在全球55个国家直接销售或通过伙伴销售,公司同时寻求新的分销伙伴。公司总部设在科罗拉多的博尔德市,制造业务位于墨西哥瓜达拉哈拉,欧洲营销和销售业务总部设在荷兰罗尔蒙德。可以在sonomapharma.com获得更多信息。如有合作机会,请联系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.

前瞻性声明
本新闻稿中除历史信息外,其他事项均为Sonoma Pharmaceuticals公司及其子公司(以下简称公司)内在"安全港"规定下前瞻性声明,包括有关公司商业和技术进展以及未来财务业绩的声明。这些新闻稿中的前瞻性声明使用诸如“继续”、“发展”、“预计”和“扩大”等词语来识别。本新闻稿中的前瞻性声明受到公司业务所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会导致实际结果发生变化,包括监管临床和指南开发可能会发生变化、科学数据可能无法满足监管标准或获得所需的监管清关或批准、临床结果可能无法在实际的患者环境中得到复制、公司专利和专利申请所提供的保护可能会受到竞争对手的挑战、作为预期的市场,公司产品面临的市场不会像预期的那么大,公司产品将无法渗透到一个或多个目标市场、收入不足以满足公司的现金需求、资金进一步发展以及不同的国家和地区之间多种多样的监管和营销要求等等。公司不承担更新这些前瞻性声明的任何义务,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:
Sonoma Pharmaceuticals, Inc.
ir@sonomapharma.com

媒体和投资者联系方式:
Sonoma Pharmaceuticals,Inc。
ir@sonomapharma.com

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SOURCE: Sonoma Pharmaceuticals, Inc.

来源:Sonoma Pharmaceuticals,Inc。


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