NuGen Medical Devices

What NuGen Medical Devices does

NuGen Medical Devices is a Toronto-headquartered, TSX Venture Exchange-listed medical device company (NGMD; OTCQB: NGMDF) that develops and commercializes needle-free jet injection technology for subcutaneous drug delivery, with manufacturing operated through its wholly-owned Dutch subsidiary European Pharma Group B.V. under ISO 13485 certification. The company's flagship InsuJet system is a reusable needle-free injector capable of delivering 5,000 injections over a 3-5 year lifetime, marketed primarily for self-administered insulin delivery by Type 1 and Type 2 diabetes patients, with additional applications in veterinary care (PetJet), pharmaceutical prefilled delivery (Gerresheimer collaboration), and US government healthcare through Unifire. InsuJet holds Health Canada approval as the first self-administered needle-free injection system and first insulin-specific needle-free system approved by that authority, CE Mark for Europe, regulatory approvals in 40+ countries, and an FDA Emergency Use Authorization application under review. Underlying technology includes a patented dual-spring architecture enabling a controlled two-phase injection profile, a patent-protected refill mechanism (granted in the Netherlands, with PCT and US/EU/China filings), and a Ready-to-Fill COP/COC needle-free injection nozzle developed for pharmaceutical prefilled applications.

The business model combines hardware sales of the reusable device with recurring consumable revenue from disposable nozzles (distribution margins reportedly above 70%) and direct-to-consumer e-commerce via insujet.com. Go-to-market is executed almost entirely through a network of exclusive 5-year territorial distribution agreements carrying minimum device purchase commitments, including Science-Link Trading (Mexico, ~CA$23M), Khotwa Medical (Middle East, ~CA$5.8M), Kuwait joint venture (CA$2M), Yemen (CA$1.4M), Iran (CA$1.1M), Sri Lanka (CA$333K), and Sol-Millennium Medical Group (Canada and Brazil, 14,250 devices). Pricing per installed device is approximately C$650 over its lifetime including consumables. Recent capital structure includes multiple private placements between 2022 and 2024 culminating in a C$10M secured convertible debenture from Sol-Millennium Medical HK and Nature Health Development in September 2024 (convertible into up to 47.89% of shares with board nomination rights), giving the company a runway to pursue pharmaceutical partnerships and additional product launches (InsuJet V6, internal cartridge system, prefilled nozzle platform) targeted through 2027.

Name

NuGen Medical Devices

Legal name

NuGen Medical Devices Inc.

Website

https://www.nugenmd.com

Company type

Public

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

NuGen Medical Devices (TSXV: NGMD) is a Toronto-based medical device company that develops needle-free jet injection systems, led by the InsuJet reusable insulin delivery device, serving diabetes patients and pharmaceutical partners across 40+ countries via exclusive distribution agreements.

Ownership category

akta.pro rank

Product category

Needle-Free Drug Delivery Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Needle-Free Injection Systems (Jet Injectors/Microneedle Patches) (HLAHAIAD)

akta.pro secondary industries

Auto-Injectors (Disposable & Reusable) (HLAHAIAB), Wearable Injectors & On-Body Delivery Systems (HLAHAIAE), Pen Injectors (Insulin/GLP-1/Other Pens) (HLAHAIAC), Insulin Pen Needles, Syringes & Infusion Sets (Consumables) (HLAHAHAE)

Keywords

• Needle-free injection
• Jet injector devices
• Insulin delivery systems
• Medical device manufacturing
• Prefilled syringe technology

Headquarters

HQ city

Toronto

HQ country

Canada

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Marketing or Sales, Personnel, Supply Chain, Others

Revenue model

1. Device Sales (Hardware): One-time revenue from sale of InsuJet needle-free injection devices. Each device can deliver 5,000 injections over ~3-5 year lifetime. Based on internal analysis, each device sold represents approximately CDN$650 revenue including recurring components over device lifetime. Distribution agreements have minimum device commitments: Mexico (34,000 devices over 5 years ~CA$23M), Canada/Brazil (14,250 devices over 2.5 years), Kuwait (CA$2M), Yemen (CA$1.4M), Iran (CA$1.1M), Sri Lanka (CA$333,000).
2. Consumables and Accessories (Recurring): Recurring revenue from sale of consumables including needle-free disposable syringes/nozzles and accessories. Each device uses 5,000 disposable components over its lifetime. Distribution margins reported at 70%+.
3. Direct E-commerce Sales: B2C subscription business launched on Shopify (insujet.com) for diabetic lifestyle products. Direct-to-consumer online brand store for EU market launched June 2022.

Pricing tiers

Go-to-market motion2 records

Distribution channels8 records

Marketing channels7 records

Core offering

NuGen Medical Devices designs, develops, manufactures, and commercializes needle-free jet injection systems for subcutaneous drug delivery. Its flagship InsuJet device enables self-administered insulin injection without traditional hypodermic needles, with each reusable device supporting approximately 5,000 injections and generating recurring revenue from disposable nozzles. The company also sells PetJet for veterinary use, EziAutoJector for the UK market, and is developing prefilled nozzle platforms with pharmaceutical partners.

Product overview

NuGen Medical Devices is an emerging specialty medical device company focused on developing and commercializing needle-free drug delivery technologies. The company's portfolio consists of core hardware products centered around jet injection technology: the InsuJet needle-free insulin delivery system (the flagship product), the PetJet for veterinary applications, and the EziAutoJector product line. The company is developing future products including the InsuJet V6 platform, prefilled nozzle systems, and internal cartridge technology. All devices use high-pressure jet injection to deliver medication subcutaneously without needles, reducing needlestick injuries, cross-contamination, and patient anxiety associated with traditional injections.

Differentiator

Problem solved

Functional benefit

Brands

• InsuJet: Needle-free injection device for insulin and medication delivery, approved in over 40 countries. Provides safe, virtually pain-free, self-administered injections with reusable device capable of 5,000 injections.
• PetJet
• EziAutoJector
• Prefilled Nozzle

Products and services

• InsuJet Needle-Free Insulin Delivery System Reusable needle-free jet injector that delivers insulin and other medications subcutaneously through high-pressure jet injection without traditional needles. Approved in over 40 countries for self-administration by diabetes patients and others requiring regular injections. Each device supports approximately 5,000 injections.
• PetJet Needle-Free Injection Device Needle-free jet injector designed for administering medication to domesticated household pets such as diabetic cats and dogs. Each device supports up to 5,000 injections and reduces stress and injury risk for pet owners and veterinarians.
• EziAutoJector Needle-free auto-injector product line for the UK market, distributed in partnership with EziAutoJector Limited and now covered by NHS Drug Tariff for prescription-based access.
• Internal Cartridge Technology Needle-Free Injection System Newly announced needle-free injection system integrating internal cartridge technology to simplify drug loading and administration.

Quantifiable outcome

• Over 40% faster insulin uptake compared to needle injections
• +6 more outcomes

Named customers10 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

14 partnerships are on record, tiered strategic, core, standard and minor.

• Gerresheimer Medical PlasticsstrategicTechnology or Integration · 25 March 2026Collaboration on Prefilled Nozzle platform developing integrated drug-device system combining prefilled nozzles with reusable auto-injectors. Samples targeted for pre-clinical testing by end of 2026; fixed-dose auto-injector launch planned for 2027.
• EziAutoJector LimitedcoreChannel Partner/ Reseller/ Distributor · 25 October 2024Strategic partnership announced October 2024. 5,000 InsuJet devices to be delivered to UK market. NHS Drug Tariff approval obtained December 2025 for EziAutoJector product line.
• Verrue Consulting GroupstandardChannel Partner/ Reseller/ Distributor · 19 December 20235-year distribution agreement for InsuJet in Belgium.
• Advance Medical Life Co.standardChannel Partner/ Reseller/ Distributor · 14 December 20235-year distribution agreement for InsuJet signed December 2023.
• Science-Link TradingcoreChannel Partner/ Reseller/ Distributor · 17 October 20225-year master distribution agreement for Mexico. Minimum 34,000 devices plus accessories representing ~CA$23M over 5-year term. COFEPRIS regulatory approval in process.
• SOL-MILLENNIUM Medical GroupcoreChannel Partner/ Reseller/ Distributor · 5 July 20225-year exclusive sales and distribution agreement for Canada and Brazil. Minimum commitments of 14,250 devices plus components. Sol-M operates manufacturing/R&D centers in Switzerland and Shanghai with global presence. Initial purchase order of 500 devices. Expanded partnership through EziAutoJector Limited strategic partnership (October 2024) delivering 5,000 InsuJet devices to UK.
• Draganfly Inc.strategicStrategic or Co-development Partner · 12 May 2022Award-winning drone solutions company (NASDAQ: DPRO) providing Medical Response Drones for delivery of InsuJet devices, insulin, and medical supplies to Ukraine conflict zones via Revived Soldiers Ukraine nonprofit.
• Coldchain Delivery Systems, Inc.minorOthers · 22 April 2022Temperature-sensitive medical material management providing remote monitoring, thermal shippers, and QAQC solutions for insulin delivery to Ukraine.
• Yemen DistributorstandardChannel Partner/ Reseller/ Distributor · 29 March 20225-year distribution agreement signed March 22, 2022 representing minimum CA$1.4M over term. Commencement pending regulatory approval.
• Unifire, Inc.coreChannel Partner/ Reseller/ Distributor · 22 March 2022Master Distribution and Marketing Agreement dated March 14, 2022 for US government agencies: DoD, BARDA, DARPA, VA, DHS, HHS. Non-exclusive rights in Israel and Australia. Wholly-owned subsidiary of Mission Ready Solutions (TSXV: MRS). FDA EUA application submitted June 2022.
• Kuwait Joint Venture (Harrington Consultants + Al Mufid Pharmaceuticals)coreChannel Partner/ Reseller/ Distributor · 16 March 20225-year distribution agreement covering Kuwait with minimum CA$2M over term. Targets market with 24.9% adult diabetes prevalence (3rd highest globally).
• Intermediq Holdings (PVT) Ltd.standardChannel Partner/ Reseller/ Distributor · 18 January 20225-year exclusive distribution for Sri Lanka with minimum CAD$333,000 over term. Commencement pending regulatory approval from Sri Lankan Health Authorities.
• Khotwa Medical Co.coreChannel Partner/ Reseller/ Distributor · 30 November 20215-year distribution agreement covering Kingdom of Saudi Arabia, Jordan, Iraq, UAE & Bahrain. Minimum CAD$5.8M over term representing over 35% of first year internal objectives.
• Iran DistributorstandardChannel Partner/ Reseller/ Distributor · 27 February 20205-year distribution agreement with minimum CA$1.1M over first 3 years. Regulatory approval received February 2022 with first purchase order received.

Scale indicators8 records

Recent moves8 records

Expansion highlights7 records

Emerging players

• Enable Injections: Enable Injections develops wearable on-body drug delivery systems for high-volume biologics. Comparable as an emerging player in the needle-free or near-painless self-administration device category, addressing the same biologics and chronic disease markets NuGen targets with its prefilled nozzle platform.

Broad incumbents

• Ypsomed: Ypsomed is a leading developer and manufacturer of pen injectors and auto-injectors for self-medication, serving pharma companies with injection platforms including prefilled systems. Comparable as a drug-delivery device specialist operating in the same injection-format category, although larger and more established.
• Becton, Dickinson and Company (BD): BD is a global leader in syringes, needles, pen needles, and auto-injector systems including prefilled syringe platforms. While much larger, BD competes with NuGen for the same insulin delivery and self-injection use cases and serves as the dominant incumbent whose installed base NuGen is attempting to disrupt.
• West Pharmaceutical Services: West Pharmaceutical Services supplies drug delivery components including prefilled syringe systems, auto-injector components, and needle-free platforms for pharmaceutical manufacturers. Comparable as a supplier/partner enabling injectable drug delivery, including needle-free and prefilled formats where NuGen's Gerresheimer partnership also sits.
• Owen Mumford: Owen Mumford manufactures auto-injectors, pen injectors, and lancets for pharmaceutical and consumer health use, including the Aidaptus auto-injector platform. Operates in the same self-administered injection device space as NuGen with broader portfolio across multiple drug-delivery formats.
• Antares Pharma (now Halozyme): Antares Pharma developed auto-injector and pen injector platforms including VIBEX and QuickClick, before being acquired by Halozyme. Directly comparable as a drug delivery device company serving pharma partners with self-administered injection technologies including needle-free and prefilled systems.

Direct peers

• Bioject Medical Technologies: Bioject pioneered needle-free jet injection systems (Biojector) for drug delivery and vaccines, historically the most direct competitor to NuGen's platform. Comparable business model focused on reusable jet injectors with disposable nozzles for both consumer and institutional use.
• PharmaJet: PharmaJet develops needle-free jet injection technology for vaccines and biologics, the closest direct competitor to NuGen's InsuJet. Both companies target subcutaneous drug delivery without needles using spring-powered jet mechanisms and pursue pharma partnerships and government/vaccination channels.

Others

• Gerresheimer: Gerresheimer is NuGen's strategic partner developing the Prefilled Nozzle platform combining COP/COC prefilled nozzles with reusable auto-injectors. Comparable as a primary drug packaging and drug-delivery device manufacturer serving pharma customers, and a direct collaborator rather than competitor.
• Sol-Millennium Medical Group: Sol-Millennium is NuGen's exclusive distribution partner for Canada/Brazil and a major investor via the C$10M convertible debenture. Comparable as a medical device manufacturer and distributor of syringes, needles, and injection accessories, sharing channel and customer overlap with InsuJet and EziAutoJector.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights5 records

Customer concentration

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Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds3 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about NuGen Medical Devices