ZenGUARD(TM) Enhanced Air Filters to Be Added as Class 1 Medical Device Under Zentek's Medical Device Establishment Licence
ZenGUARD(TM) Enhanced Air Filters to Be Added as Class 1 Medical Device Under Zentek's Medical Device Establishment Licence
Independent proof-of-concept testing and validation was completed by the National Research Council of Canada in their unique bioaerosol facility, a purpose-built modular room intended to simulate the risk of infection in a real-world classroom environment. LMS Technologies Inc. was subsequently contracted to test ZenGUARD Enhanced Air Filter finished products and reported an average viral filtration efficiency ("VFE") enhancement of ~66% compared to an untreated filter, or an average ~67% VFE under simulated operating conditions over 6 months with negligible change in pressure drop.GUELPH, ON / ACCESSWIRE / November 27, 2024 / Zentek Ltd. ("Zentek" or the "Company") (Nasdaq:ZTEK)(TSX-V:ZEN), an intellectual property development and commercialization company, announces its decision that its ZenGUARD Enhanced Air Filters will be added under the company's existing medical device establishment licence ("MDEL"), similar to ZenGUARD Surgical Masks.
GUELPH, ON / ACCESSWIRE / 2024年11月27日 / Zentek有限公司（"Zentek"或"公司"）（纳斯达克:ZTEK）（TSX-V:ZEN），一家知识产权开发和商业化公司，宣布其决定，其ZenGUARD增强空气过滤器将被添加到公司现有的医疗器械成立许可证（"MDEL"）下，类似于ZenGUARD外科口罩。
Initial test work and validation began on ZenGUARD Enhanced Air Filters in early 2021, culminating in the award of an Innovative Solutions Canada ("ISC") Testing Stream.
ZenGUARD增强空气过滤器的初步测试工作和验证工作于2021年初开始，最终获得加拿大创新解决方案（"ISC"）测试流程奖。
The purpose of the ISC Testing Stream - The Government of Canada contract awarded in 2021 - was to determine whether ZenGUARD Enhanced Air Filters could achieve a significant net reduction in airborne respiratory pathogens, thereby validating it as an effective device to mitigate the transmission of disease.
ISC测试流程的目的 - 2021年获得的加拿大政府合同 - 是判断ZenGUARD增强空气过滤器是否能够显著降低空气传播的呼吸道病原体，从而证实其作为一种有效器械以减少疾病传播的设备。
Independent proof-of-concept testing and validation was completed by the National Research Council of Canada in their unique bioaerosol facility, a purpose-built modular room intended to simulate the risk of infection in a real-world classroom environment. LMS Technologies Inc. was subsequently contracted to test ZenGUARD Enhanced Air Filter finished products and reported an average viral filtration efficiency ("VFE") enhancement of ~66% compared to an untreated filter, or an average ~67% VFE under simulated operating conditions over 6 months with negligible change in pressure drop.
加拿大国家研究委员会在他们独特的生物气溶胶设施中完成了独立的概念验证测试，这是一个专门建造的模块化房间，旨在模拟真实教室环境中感染风险。随后，LMS Technologies Inc.被承包测试ZenGUARD增强空气过滤器成品，并报告与未经处理的过滤器相比平均病毒过滤效率（"VFE"）提高约66%，或在模拟运行条件下平均超过6个月的VFE水平增加了约67％，同时对气压下降几乎没有变化。
This extensive testing program was conducted over the course of approximately two years and successfully demonstrated that ZenGUARD Enhanced Air Filters can achieve a significant reduction in airborne respiratory pathogens to help mitigate the transmission of disease indoors.
这项广泛的测试计划历时约两年，成功证明了ZenGUARD增强空气过滤器能够显著降低空气中的呼吸道病原体，有助于减少疾病在室内的传播。
To further validate this, the Company completed a study with ParticleOne, a RWDI Ventures company. ParticleOne's computational model showcased ZenGUARD Enhanced Air Filter's viral filtration action, effectively reducing the spread of viral pathogens and enhancing indoor safety. It also demonstrated potential cost savings from absenteeism related to poor indoor air quality.
为了进一步验证这一点，公司与ParticleOne进行了一项研究，ParticleOne是RWDI Ventures公司。 ParticleOne的计算模型展示了ZenGUARD增强空气过滤器的病毒过滤作用，有效地减少了病毒病原体的传播并增强了室内安全性。它还展示了因室内空气质量不佳而导致的缺勤相关潜在成本节省。
Quality Management System
质量管理体系
Prior to distributing and selling an additional medical device in Canada, certain testing, process updates and additional documentation related to the Company's supply chain will be required to qualify ZenGUARD Enhanced Air Filters as a medical device under its MDEL and ensure compliance with its ISO 13485:2016 Quality Management System. While this process will take additional time and resources, the Company expects it to be significantly less than that required under the previous pathway to market being pursued.
在加拿大分销和销售额外医疗器械之前，必须进行特定测试、流程更新和与公司供应链相关的额外文档，以使ZenGUARD增强空气过滤器符合其MDEL的医疗器械要求，并确保符合其ISO 13485:2016质量管理体系。尽管这一过程将需要额外的时间和资源，但公司预计所需时间将明显少于之前所追求的市场途径所需时间。
"ZenGUARD Enhanced Air Filters will offer a safe and effective way to help prevent the transmission of disease indoors without increasing energy consumption and emissions. This unique value proposition was borne out of an ask from the Government of Canada's Innovation Science and Economic Development agency - and we look forward to fulfilling that ask and helping many others in Canada with a safe and effective technology," said Greg Fenton, CEO of Zentek.
“ZenGUARD增强空气过滤器将以一种安全有效的方式帮助预防室内疾病传播，而不会增加能源消耗和排放。这一独特的价值主张源自加拿大政府创新科技和经济发展机构的要求，我们期待着完成这一任务并利用安全有效的技术帮助加拿大的许多人，”Zentek的首席执行官Greg Fenton说。
Management Changes
管理层变动
The Company also announces that Nick Hansford, Vice President, Strategy and Product Development, and member of the Zentek management team, has left the company to pursue other opportunities.
该公司还宣布，戴尔赫斯福德（Nick Hansford），战略和产品开发副总裁，Zentek管理团队成员已离开公司寻求其他机会。
About Zentek Ltd.
关于Zentek Ltd。
Zentek is an ISO 13485:2016 certified intellectual property technology company focused on the research, development and commercialization of novel products seeking to give the Company's commercial partners a competitive advantage by making their products better, safer, and greener.
Zentek是一家ISO13485：2016认证的知识产权技术公司，专注于研究、开发和商业化旨在使公司商业合作伙伴通过使其产品更好、更安全和更绿色而获得竞争优势的新产品。
Zentek's patented technology platform ZenGUARD is shown to have enhanced viral filtration efficiency for surgical masks and aims to do the same for HVAC (heating, ventilation, and air conditioning) systems. Zentek's ZenGUARD production facility is in Guelph, Ontario.
Zentek专利技术平台ZenGUARD已被证明在外科口罩上具有增强的病毒过滤效率，并旨在为暖通空调系统做同样。Zentek的ZenGUARD生产设施位于安大略省圭尔夫。
For further information on Zentek:
有关Zentek的更多信息，请参见以下资料：
investorrelations@zentek.com
investorrelations@zentek.com
Ryan Shacklock
Senior VP, Strategy & Business Development
Email: rshacklock@zentek.com
Phone: 306-270-9610
Ryan Shacklock
高级副总裁，策略和业务发展
电子邮件：rshacklock@zentek.com
电话：306-270-9610
To find out more about Zentek, please visit our website at . A copy of this news release and all material documents in respect of the Company may be obtained on Zentek's SEDAR+ profile at .
欲了解更多有关Zentek的信息，请访问我们的网站。公司新闻稿的副本和有关公司的所有物料文件均可在Zentek的SEDAR+配置文件中获取。
Forward-Looking Statements
前瞻性声明
This news release contains forward-looking statements. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Although Zentek believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. Zentek disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.
此新闻稿包含前瞻性陈述。由于前瞻性陈述涉及未来事件和情况，因此它们本质上包含固有的风险和不确定性。尽管Zentek认为在准备本新闻稿中的前瞻性信息时使用的假设和因素是合理的，但不应过度依赖此类信息，因为它仅适用于本新闻稿的发布日，并且不能保证此类事件将在披露的时间范围内或根本发生。Zentek放弃任何更新或修订任何前瞻性信息的意图或义务，除非法律规定。
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
TSX创业公司交易所或其监管服务提供商（如TSX创业公司政策中定义的那样）不对本公告的充分性或准确性负责。
SOURCE: Zentek
消息来源：Zentek
