ZenGUARD(TM) Enhanced Air Filters to Be Added as Class 1 Medical Device Under Zentek's Medical Device Establishment Licence
Zentek (NASDAQ:ZTEK) announces plans to add ZenGUARD™ Enhanced Air Filters under its existing medical device establishment licence (MDEL). Independent testing showed the filters achieve ~66% viral filtration efficiency enhancement compared to untreated filters, maintaining ~67% VFE over 6 months with minimal pressure drop changes. A ParticleOne study demonstrated the product's effectiveness in reducing viral pathogens and potential cost savings from reduced absenteeism. The company will need additional testing and documentation to qualify the filters as a medical device under MDEL and ISO 13485:2016 compliance. Additionally, Nick Hansford, VP of Strategy and Product Development, has departed the company.
Zentek (NASDAQ:ZTEK) annuncia l'intenzione di aggiungere i filtri d'aria migliorati ZenGUARD™ sotto la sua licenza esistente di stabilimento per dispositivi medici (MDEL). Test indipendenti hanno mostrato che i filtri raggiungono un miglioramento dell'efficienza di filtrazione virale di circa il 66% rispetto ai filtri non trattati, mantenendo circa il 67% di VFE per sei mesi con minime variazioni nella caduta di pressione. Uno studio di ParticleOne ha dimostrato l'efficacia del prodotto nella riduzione dei patogeni virali e dei potenziali risparmi sui costi dovuti alla riduzione dell'assenteismo. L'azienda avrà bisogno di ulteriori test e documentazione per qualificare i filtri come dispositivi medici secondo MDEL e conformità ISO 13485:2016. Inoltre, Nick Hansford, VP di Strategia e Sviluppo Prodotto, ha lasciato l'azienda.
Zentek (NASDAQ:ZTEK) anuncia planes para añadir los filtros de aire mejorados ZenGUARD™ bajo su licencia existente de establecimiento de dispositivos médicos (MDEL). Pruebas independientes mostraron que los filtros logran una mejora de aproximadamente el 66% en la eficiencia de filtración viral en comparación con los filtros sin tratar, manteniendo alrededor del 67% de VFE durante 6 meses con cambios mínimos en la caída de presión. Un estudio de ParticleOne demostró la efectividad del producto en la reducción de patógenos virales y los posibles ahorros de costos derivados de la reducción del absentismo. La empresa necesitará pruebas y documentación adicionales para calificar los filtros como dispositivos médicos bajo MDEL y cumplimiento con ISO 13485:2016. Además, Nick Hansford, VP de Estrategia y Desarrollo de Productos, ha dejado la empresa.
젠텍(Zentek, NASDAQ:ZTEK)은 기존 의료 기기 제조 면허(MDEL) 하에 ZenGUARD™ 향상된 공기 필터를 추가할 계획을 발표했습니다. 독립 테스트에 따르면, 이 필터는 처리되지 않은 필터에 비해 약 66%의 바이러스 필터링 효율성 향상을 달성하며, 압력 강하의 최소한의 변화로 6개월 동안 약 67%의 VFE를 유지합니다. ParticleOne의 연구는 제품이 바이러스 병원체를 줄이는 데 효과적이며 결근 감소로 인한 비용 절감 효과를 보여주었습니다. 회사는 MDEL 및 ISO 13485:2016 준수에 따라 필터를 의료 기기로 자격을 부여하기 위해 추가 테스트 및 문서화가 필요합니다. 또한, 전략 및 제품 개발 담당 부사장인 닉 한스포드(Nick Hansford)가 회사를 떠났습니다.
Zentek (NASDAQ:ZTEK) annonce des plans pour ajouter les filtres d'air améliorés ZenGUARD™ sous sa licence existante d'établissement de dispositifs médicaux (MDEL). Des tests indépendants ont montré que les filtres atteignent environ 66 % d'amélioration de l'efficacité de filtration virale par rapport aux filtres non traités, maintenant environ 67 % de VFE pendant 6 mois avec des variations minimales de chute de pression. Une étude de ParticleOne a démontré l'efficacité du produit à réduire les agents pathogènes viraux et les économies potentielles dues à la réduction de l'absentéisme. L'entreprise aura besoin de tests et de documentation supplémentaires pour qualifier les filtres comme dispositifs médicaux conformément à la MDEL et à la norme ISO 13485:2016. De plus, Nick Hansford, VP de la stratégie et du développement de produits, a quitté l'entreprise.
Zentek (NASDAQ:ZTEK) kündigt Pläne an, die verbesserten Luftfilter ZenGUARD™ unter seiner bestehenden Lizenz für Medizingeräte (MDEL) hinzuzufügen. Unabhängige Tests zeigten, dass die Filter eine Verbesserung der viralen Filtrationseffizienz von etwa 66 % im Vergleich zu unbehandelten Filtern erreichen und über einen Zeitraum von 6 Monaten mit minimalen Druckverluständerungen etwa 67 % VFE aufrechterhalten. Eine Studie von ParticleOne demonstrierte die Wirksamkeit des Produkts bei der Reduzierung viraler Krankheitserreger und mögliche Kosteneinsparungen durch reduzierte Fehlzeiten. Das Unternehmen benötigt zusätzliche Tests und Dokumentationen, um die Filter gemäß MDEL und ISO 13485:2016 als Medizinprodukte zu qualifizieren. Darüber hinaus hat Nick Hansford, VP für Strategie und Produktentwicklung, das Unternehmen verlassen.
- Independent testing confirms 66% improvement in viral filtration efficiency
- Maintained 67% VFE over 6 months with minimal performance degradation
- ParticleOne study validates potential cost savings from reduced absenteeism
- Faster pathway to market under existing MDEL compared to previous approach
- Additional testing and documentation required before commercialization
- Loss of key executive (VP of Strategy and Product Development)
Insights
The reclassification of ZenGUARD™ Enhanced Air Filters as a Class 1 medical device represents a strategic regulatory pathway that could accelerate market entry. The extensive validation data showing
- The company still needs to complete additional testing and documentation for MDEL compliance
- No clear timeline or revenue projections are provided
- The departure of the VP of Strategy & Product Development during this transition phase adds uncertainty
While the technology shows promise for indoor pathogen reduction, investors should monitor the execution of regulatory requirements and commercialization strategy before expecting significant financial impact.
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.
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.
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.
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.
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.
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.
Quality Management System
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.
"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.
Management Changes
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.
About 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'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.
For further information on Zentek:
Ryan Shacklock
Senior VP, Strategy & Business Development
Email: rshacklock@zentek.com
Phone: 306-270-9610
To find out more about Zentek, please visit our website at www.Zentek.com. A copy of this news release and all material documents in respect of the Company may be obtained on Zentek's SEDAR+ profile at http://www.sedarplus.ca/.
Forward-Looking Statements
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.
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.
SOURCE: Zentek
View the original press release on accesswire.com
FAQ
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