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NuGen Medical Devices Announces New Needle-Free Injection System Featuring Internal Cartridge Technology

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NuGen Medical Devices (TSXV: NGMD) has announced the development of a next-generation needle-free injection system featuring innovative internal cartridge technology. The system, protected under international patent WO2021206553, integrates a sterile internal insulin cartridge into their proprietary autoinjector.

The new design eliminates the need for external connectors and manual filling, offering improved safety and ease of use compared to current systems like InsuJet. Key technical features include an internal cartridge integration, backflow control mechanism, and enhanced usability.

Under CEO Liang Lin's leadership, NuGen plans to begin clinical investigations using their current platform while developing the new system. The company aims to produce working prototypes within six months and begin tooling investment in early 2026.

NuGen Medical Devices (TSXV: NGMD) ha annunciato lo sviluppo di un sistema di iniezione senza ago di nuova generazione, basato su una tecnologia innovativa di cartucce interne. Il dispositivo, tutelato dal brevetto internazionale WO2021206553, integra una cartuccia sterile per insulina all'interno del loro autoiniettore proprietario.

Il nuovo progetto elimina la necessità di connettori esterni e di riempimento manuale, offrendo maggiore sicurezza e facilità d'uso rispetto a soluzioni esistenti come InsuJet. Tra le caratteristiche tecniche principali figurano l'integrazione della cartuccia interna, un meccanismo di controllo del reflusso e miglioramenti nell'usabilità.

Sotto la guida dell'amministratore delegato Liang Lin, NuGen intende avviare indagini cliniche con la piattaforma attuale mentre sviluppa il nuovo sistema. L'azienda punta a realizzare prototipi funzionanti entro sei mesi e a iniziare gli investimenti per gli stampi a inizio 2026.

NuGen Medical Devices (TSXV: NGMD) ha anunciado el desarrollo de un sistema de inyección sin aguja de próxima generación que incorpora una innovadora tecnología de cartuchos internos. El sistema, protegido por la patente internacional WO2021206553, integra un cartucho estéril de insulina en su autoinyector propietario.

El nuevo diseño elimina la necesidad de conectores externos y de llenado manual, ofreciendo mayor seguridad y facilidad de uso frente a sistemas actuales como InsuJet. Sus principales características técnicas incluyen la integración del cartucho interno, un mecanismo de control de reflujo y una usabilidad mejorada.

Bajo la dirección del CEO Liang Lin, NuGen planea iniciar investigaciones clínicas con su plataforma actual mientras desarrolla el nuevo sistema. La compañía aspira a fabricar prototipos operativos en seis meses e iniciar la inversión en herramientas a comienzos de 2026.

NuGen Medical Devices (TSXV: NGMD)는 혁신적인 내부 카트리지 기술을 적용한 차세대 무침 주입 시스템 개발을 발표했습니다. 해당 시스템은 국제 특허 WO2021206553으로 보호되며, 자체 자동주사기에 무균 인슐린 내부 카트리지를 통합합니다.

새 설계는 외부 커넥터와 수동 충전을 필요로 하지 않아 InsuJet 같은 기존 시스템보다 안전성과 사용 편의성이 향상됩니다. 주요 기술적 특징으로는 내부 카트리지 통합, 역류 제어 메커니즘, 향상된 사용성이 포함됩니다.

CEO Liang Lin의 지휘 아래 NuGen은 새 시스템을 개발하는 동안 현재 플랫폼으로 임상 조사를 시작할 계획입니다. 회사는 6개월 내 작동 가능한 프로토타입을 제작하고 2026년 초부터 금형 투자를 시작하는 것을 목표로 하고 있습니다.

NuGen Medical Devices (TSXV: NGMD) a annoncé le développement d'un système d'injection sans aiguille de nouvelle génération intégrant une technologie innovante de cartouche interne. Le dispositif, protégé par le brevet international WO2021206553, intègre une cartouche stérile d'insuline dans leur autoinjecteur propriétaire.

La nouvelle conception élimine le besoin de connecteurs externes et de remplissage manuel, offrant une sécurité et une facilité d'utilisation supérieures aux systèmes actuels tels qu'InsuJet. Les caractéristiques techniques clés comprennent l'intégration de la cartouche interne, un mécanisme de contrôle du reflux et une ergonomie améliorée.

Sous la direction du PDG Liang Lin, NuGen prévoit de lancer des investigations cliniques avec sa plateforme actuelle tout en développant le nouveau système. L'entreprise vise à produire des prototypes opérationnels sous six mois et à commencer les investissements en outillage début 2026.

NuGen Medical Devices (TSXV: NGMD) hat die Entwicklung eines nächsten Generation nadelfreien Injektionssystems mit innovativer interner Kartuschen-Technologie angekündigt. Das System, geschützt durch das internationale Patent WO2021206553, integriert eine sterile Insulinkartusche in ihren proprietären Autoinjektor.

Das neue Design macht externe Verbinder und manuelles Befüllen überflüssig und bietet im Vergleich zu bestehenden Systemen wie InsuJet verbesserte Sicherheit und Bedienfreundlichkeit. Zu den technischen Kernmerkmalen gehören die Integration der internen Kartusche, ein Rückflusskontrollmechanismus und verbesserte Gebrauchstauglichkeit.

Unter der Leitung von CEO Liang Lin plant NuGen, mit der bestehenden Plattform klinische Untersuchungen zu beginnen, während das neue System entwickelt wird. Das Unternehmen strebt an, innerhalb von sechs Monaten funktionsfähige Prototypen zu fertigen und Anfang 2026 mit Investitionen in die Werkzeugherstellung zu starten.

Positive
  • Patent protection secured in EU and China, with pending applications in Canada and US
  • Eliminates manual filling steps, reducing contamination and dosing error risks
  • Improved safety and usability compared to current needle-free systems
  • Parallel development approach allows faster clinical validation
Negative
  • Full tooling investment and commercialization not starting until 2026
  • Patent approvals still pending in key markets (US and Canada)
  • Working prototypes not yet available for demonstration

Toronto, Ontario--(Newsfile Corp. - August 21, 2025) - NuGen Medical Devices Inc. (TSXV: NGMD) ("NuGen" or the "Company"), a leader in needle-free subcutaneous drug-delivery technology, is pleased to announce research and development of a next-generation needle-free injection system, in drug delivery technology. This innovation, protected under international patent WO2021206553 (granted in the EU and China; pending in Canada and the US), introduces a cartridge-based solution that simplifies drug administration and enhances patient safety.

At the heart of this breakthrough is the integration of a sterile internal insulin cartridge into NuGen's proprietary needle-free autoinjector, an innovation conceived by Nicky Canton, the inventor behind the patent. Unlike current systems such as InsuJet, which require external connectors to manually draw insulin into a temporary reservoir, this new design eliminates that step entirely. The result is a safer, more intuitive experience for patients, with reduced risk of dosing errors and contamination.

"This innovation is anticipated to be most welcomed for patients who rely on daily injections," said Liang Lin, CEO of NuGen Medical Devices. "By embedding a prefilled cartridge directly into our needle-free platform, this will become a solution that rivals the convenience of pen-based injectors, without the needle."

Technical Highlights of the Innovation:

  • Internal Cartridge Integration: Removes the need for external adaptors and manual filling, streamlining the injection process.

  • Backflow Control Mechanism: Addresses high-pressure backflow challenges unique to jet injection, ensuring precise and safe insulin delivery.

  • Improved Usability: Simplifies operation for patients and caregivers, reducing training time and improving compliance.

Under Liang Lin's leadership, the Company has expanded its internal R&D, quality, and clinical teams to support this development, with a focus on regulatory compliance and clinical validation.

Future Milestones:

  • Clinical Investigations: Since the efficacy of needle-free injections is not affected by this design change, NuGen will begin clinical investigations using its currently approved needle-free platform. This allows parallel development of the new cartridge-based system while generating clinical data for new drug indications.

  • Prototype Development: Within six months, NuGen aims to produce working prototypes to showcase the technology and conduct usability studies.

  • Tooling Investment: Full tooling investment is expected to commence in early 2026, paving the way for scaled manufacturing and commercialization.

NuGen remains committed to advancing needle-free solutions that emphasize patient comfort, safety, and usability, redefining how medications are delivered across therapeutic areas.

About NuGen Medical Devices

NuGen develops next-generation needle-free devices for subcutaneous drug delivery. Its flagship InsuJet™ system is approved in 42 countries and is designed to improve the lives of millions of people with diabetes worldwide.

Websites: insujet.com | insujet.fr | nugenmd.com

Instagram / X: @NuGenMD | LinkedIn: NuGenMD

Investor Relations: IR@nugenmd.com

For further information, please contact:
Liang Lin, Chief Executive Officer
+1 (833) 285-2666
ir@nugenmd.com

Notice Regarding Forward-Looking Information:

Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accept responsibility for the adequacy or accuracy of this release.

This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. These forward-looking statements are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. The forward-looking information contained herein is given as of the date hereof and the Company assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263223

FAQ

What is NuGen Medical's new needle-free injection system technology?

NuGen's new system features an integrated internal insulin cartridge technology that eliminates the need for external connectors and manual filling, making drug administration safer and more intuitive for patients.

When will NuGen's new cartridge-based injection system be available?

NuGen plans to produce working prototypes within 6 months and begin tooling investment in early 2026, with commercialization to follow.

What are the key benefits of NuGen's new needle-free injection system?

The system offers improved safety through reduced contamination risk, eliminates manual filling steps, includes backflow control mechanisms, and provides enhanced usability compared to current systems.

What patents does NuGen have for their new injection system?

The technology is protected under international patent WO2021206553, which has been granted in the EU and China, with pending applications in Canada and the US.

How will NuGen conduct clinical trials for the new injection system?

NuGen will conduct clinical investigations using their currently approved needle-free platform while developing the new cartridge-based system in parallel.
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