Zentek Completes Shelf-Life Efficacy Testing for ZenGUARD(TM) Enhanced Air Filter Commercialization
Zentek (NASDAQ:ZTEK) has completed important shelf-life efficacy testing for its ZenGUARD™ Enhanced Air Filters, a key requirement for medical device compliance. The testing revealed that after 20 months of aging, the filters maintained consistent performance with an initial viral filtration efficiency (VFE) of 38.1%, comparable to the original 37.7%.
The shedding test results confirmed excellent coating adhesion over the 20-month period, with particle counts remaining within statistical deviation of background levels. Based on these results, ZenGUARD™ Enhanced Air Filters will receive a 20-month expiry date from manufacture.
This milestone follows the November 27, 2024 announcement of manufacturing and selling these filters as a Class I medical device under the company's medical device establishment licence (MDEL). Zentek is now finalizing documentation to support manufacture and sale alongside ZenGUARD™ Surgical Masks, in compliance with Canadian Medical Device Regulations and ISO 13485:2016 standards.
Zentek (NASDAQ:ZTEK) ha completato importanti test di efficacia per la durata di vita dei suoi filtri d'aria ZenGUARD™ Enhanced, un requisito fondamentale per la conformità ai dispositivi medici. I test hanno rivelato che, dopo 20 mesi di invecchiamento, i filtri hanno mantenuto prestazioni costanti con un'efficienza di filtrazione virale (VFE) iniziale del 38,1%, paragonabile al 37,7% originale.
I risultati del test di rilascio hanno confermato un'eccellente adesione del rivestimento nel corso dei 20 mesi, con conteggi di particelle che sono rimasti all'interno della deviazione statistica dei livelli di fondo. Sulla base di questi risultati, i filtri d'aria ZenGUARD™ Enhanced riceveranno una data di scadenza di 20 mesi dalla produzione.
Questo traguardo segue l'annuncio del 27 novembre 2024 riguardante la produzione e la vendita di questi filtri come dispositivo medico di Classe I sotto la licenza di stabilimento di dispositivi medici dell'azienda (MDEL). Zentek sta ora finalizzando la documentazione per supportare la produzione e la vendita insieme alle maschere chirurgiche ZenGUARD™, in conformità con le normative canadesi sui dispositivi medici e gli standard ISO 13485:2016.
Zentek (NASDAQ:ZTEK) ha completado pruebas importantes de eficacia para la vida útil de sus filtros de aire ZenGUARD™ Enhanced, un requisito clave para el cumplimiento de dispositivos médicos. Las pruebas revelaron que, después de 20 meses de envejecimiento, los filtros mantuvieron un rendimiento constante con una eficiencia de filtración viral (VFE) inicial del 38.1%, comparable al 37.7% original.
Los resultados de la prueba de desprendimiento confirmaron una excelente adhesión del recubrimiento durante el período de 20 meses, con recuentos de partículas que permanecieron dentro de la desviación estadística de los niveles de fondo. Basado en estos resultados, los filtros de aire ZenGUARD™ Enhanced recibirán una fecha de caducidad de 20 meses a partir de la fabricación.
Este hito sigue al anuncio del 27 de noviembre de 2024 sobre la fabricación y venta de estos filtros como dispositivo médico de Clase I bajo la licencia de establecimiento de dispositivos médicos de la empresa (MDEL). Zentek está finalizando ahora la documentación para apoyar la fabricación y venta junto con las mascarillas quirúrgicas ZenGUARD™, en cumplimiento con las regulaciones canadienses de dispositivos médicos y los estándares ISO 13485:2016.
젠텍(Zentek) (NASDAQ:ZTEK)은 의료기기 준수를 위한 핵심 요구 사항인 자사 제안형 공기 필터 ZenGUARD™ Enhanced의 유효 기간 효능 테스트를 완료했습니다. 테스트 결과, 20개월의 노화 후 필터는 초기 바이러스 필터링 효율(VFE) 38.1%를 유지하며, 이는 원래의 37.7%와 유사한 성능을 보였습니다.
탈락 테스트 결과는 20개월 동안 우수한 코팅 접착력을 확인했으며, 입자 수는 배경 수준의 통계적 편차 내에 유지되었습니다. 이 결과를 바탕으로 ZenGUARD™ Enhanced 공기 필터는 제조일부터 20개월의 유효 기간을 부여받게 됩니다.
이 이정표는 2024년 11월 27일에 발표된 이 필터의 제조 및 판매가 회사의 의료기기 시설 라이센스(MDEL) 하에 클래스 I 의료기기로 진행된다는 발표에 이어 나온 것입니다. 젠텍은 현재 캐나다 의료기기 규정 및 ISO 13485:2016 기준을 준수하여 ZenGUARD™ 수술 마스크와 함께 제조 및 판매를 지원하기 위한 문서 작업을 마무리하고 있습니다.
Zentek (NASDAQ:ZTEK) a terminé des tests importants sur l'efficacité de la durée de vie de ses filtres à air ZenGUARD™ Enhanced, une exigence clé pour la conformité des dispositifs médicaux. Les tests ont révélé qu'après 20 mois de vieillissement, les filtres ont maintenu des performances constantes avec une efficacité de filtration virale (VFE) initiale de 38,1 %, comparable à l'originale de 37,7 %.
Les résultats du test de décollement ont confirmé une excellente adhérence du revêtement pendant la période de 20 mois, les comptages de particules restant dans la déviation statistique des niveaux de fond. Sur la base de ces résultats, les filtres à air ZenGUARD™ Enhanced recevront une date d'expiration de 20 mois à compter de la fabrication.
Ce jalon fait suite à l'annonce du 27 novembre 2024 concernant la fabrication et la vente de ces filtres en tant que dispositif médical de Classe I sous la licence d'établissement de dispositifs médicaux de l'entreprise (MDEL). Zentek finalise maintenant la documentation pour soutenir la fabrication et la vente des masques chirurgicaux ZenGUARD™, en conformité avec les réglementations canadiennes sur les dispositifs médicaux et les normes ISO 13485:2016.
Zentek (NASDAQ:ZTEK) hat wichtige Tests zur Wirksamkeit der Haltbarkeit seiner ZenGUARD™ Enhanced Luftfilter abgeschlossen, die eine Schlüsselanforderung für die Konformität mit medizinischen Geräten darstellen. Die Tests ergaben, dass die Filter nach 20 Monaten Alterung eine konsistente Leistung mit einer anfänglichen viralen Filtrationseffizienz (VFE) von 38,1 % beibehielten, was mit den ursprünglichen 37,7 % vergleichbar ist.
Die Ergebnisse des Ablösungstests bestätigten eine hervorragende Beschichtungsadhäsion über den Zeitraum von 20 Monaten, wobei die Partikelzahlen innerhalb der statistischen Abweichung der Hintergrundwerte blieben. Basierend auf diesen Ergebnissen werden die ZenGUARD™ Enhanced Luftfilter ein Verfallsdatum von 20 Monaten ab Herstellung erhalten.
Dieser Meilenstein folgt der Ankündigung vom 27. November 2024 über die Herstellung und den Verkauf dieser Filter als Medizinprodukt der Klasse I unter der medizinischen Geräteeinrichtungs-Lizenz (MDEL) des Unternehmens. Zentek finalisiert nun die Dokumentation zur Unterstützung der Herstellung und des Verkaufs zusammen mit den ZenGUARD™ chirurgischen Masken, in Übereinstimmung mit den kanadischen Vorschriften für Medizinprodukte und den ISO 13485:2016 Standards.
- Successful completion of medical device compliance testing
- Proven 20-month product stability with consistent performance
- Ready for commercialization as Class I medical device
- Demonstrated coating durability with excellent adhesion
- Relatively low viral filtration efficiency at 38.1%
Insights
Zentek's completion of shelf-life efficacy testing for its ZenGUARD™ Enhanced Air Filters represents a critical regulatory milestone. The 20-month aging tests demonstrating consistent viral filtration efficiency (VFE) of approximately
The testing documentation provides Zentek with the necessary evidence to establish a 20-month expiry date on product labeling, which is mandatory for medical devices in Canada. This directly supports the company's strategy to manufacture and sell these filters under their existing Medical Device Establishment License (MDEL).
From a regulatory perspective, the successful completion of both VFE and shedding tests satisfies the "End Product Stability and Performance Testing" requirements, effectively clearing a significant hurdle in the regulatory pathway. The company's mention of ISO 13485:2016 compliance indicates they're aligning with international quality management standards for medical devices, which could potentially facilitate future market expansion beyond Canada.
While this testing completion is necessary for regulatory compliance, Zentek still needs to finalize documentation before actual commercialization can begin. The measured
This regulatory progress for Zentek's ZenGUARD™ Enhanced Air Filters represents an incremental step toward commercialization rather than an immediate financial catalyst. With a market cap of
The company has successfully demonstrated product stability and consistent performance over a 20-month period, validating the technical aspects of their air filtration technology. However, several key commercial variables remain undefined:
- No timeline provided for commercial launch
- Absence of market size estimates or addressable market information
- No pricing structure or production cost details
- No competitive positioning analysis against established filtration products
The CEO's characterization of the commercialization journey as "long" suggests potential obstacles or complexities in bringing this product to market. The modest viral filtration efficiency of
This development does indicate Zentek is methodically progressing through necessary regulatory steps to expand their medical device portfolio beyond surgical masks. For investors, this represents progress in de-risking the product development pathway, but lacks sufficient data to project meaningful financial impact in the near term.
GUELPH, ON / ACCESS Newswire / March 12, 2025 / Zentek Ltd. ("Zentek" or the "Company") (NASDAQ:ZTEK)(TSXV:ZEN), an intellectual property technology development and commercialization company announces that shelf-life efficacy testing has been completed on aged ZenGUARD™ Enhanced Air Filters, which is required for medical device compliance.
Highlights
ZenGUARD™ Enhanced Air Filters were aged for 20 months prior to testing to establish the product's shelf life
Viral filtration efficiency ("VFE") was unchanged after aging demonstrating that the ZenGUARD™ coating has a consistent performance over a duration of 20 months
ZenGUARD™ Enhanced Air Filters
On November 27, 2024, Zentek announced that the Company will manufacture and sell its ZenGUARD™ Enhanced Air Filters as a Class I medical device under its medical device establishment licence ("MDEL"). The change in regulatory pathway required the completion of "End Product Stability and Performance Testing." These tests are essential for medical devices as products must demonstrate consistent performance and safety of the device until a subsequent expiry date. The expiry date must be clearly identified on the label of all medical devices.
ZenGUARD™ Enhanced Air Filters were real-time aged for 20 months and then submitted to LMS Technologies, Inc. ("LMS") for VFE and shedding testing. The VFE was tested for the aged filters to determine the reduction in bioaerosols that is achieved under normal operating conditions with an airflow of 500 ft/min and was consistent with ASHRAE 241 Section L standards. The recently completed testing of the 20-month aged filters measured an initial VFE of
Likewise, a shedding test on the 20-month-aged filters was completed using a laser particle counter to determine the number and size of particles in the airstream under normal operating conditions (500 ft/min airflow). The shedding test demonstrated that the coating maintains excellent adhesion to the substrate over 20 months as the number of particles counted in the airstream after passing through the filter were within statistical deviation with the background particle counts measured with no filter present in the test chamber.
Based on the VFE and shedding test results, ZenGUARD™ Enhanced Air Filters will be labelled with a 20-month expiry from the date of manufacture.
The Company continues to prioritize the completion of all required documentation to support the manufacture and sale of ZenGUARD™ Enhanced Air Filters under its existing MDEL alongside ZenGUARD™ Surgical Masks. This documentation will be completed in compliance with Canadian Medical Device Regulations and ISO 13485:2016 Quality Management System for medical devices.
Greg Fenton, Zentek's CEO, commented: "The pathway to commercialization for ZenGUARD™ Enhanced Air Filters has been a long journey and we are pleased to have finally completed all testing necessary required for a medical device. These recent results further demonstrate to users that ZenGUARD™ Enhanced Air Filters are an effective and safe solution to help reduce the transmission of infectious bioaerosols up to the expiry date. We look forward to providing further announcements as we move towards commercialization."
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 significantly increase the bacterial and viral filtration efficiency for surgical masks and aims to do the same with HVAC (heating, ventilation, and air conditioning) filters. Zentek's ZenGUARD™ production facility is in Guelph, Ontario.
Zentek, through its wholly owned subsidiary, Triera Biosciences Ltd., has a global exclusive licence to the aptamer-based platform technology developed by McMaster University, which is being jointly developed by Zentek and McMaster for both the diagnostic and therapeutic markets.
For further information:
Ryan Shacklock
Email: rshacklock@zentek.com
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 ACCESS Newswire
FAQ
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