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Congruence Medical Solutions LLC
The Congruence Autoinjector is a next generation disposable autoinjector platform, capable of delivering high-dose drugs and suitable for home use (self-injection).
It leverages a compressed-gas power source and proprietary usability features to offer several advantages over legacy devices, including the ability to deliver higher viscosity and/or larger volume drugs, enhanced usability and easier customization – all in a compact format while incorporating standard primary containers.
The Congruence Autoinjector’s novel usability features, such as Injection Pause™ Technology, mitigate well-known autoinjector user errors, such as premature removal from the skin prior to dose completion.
Configurations
Key Benefits
Availability
- Disposable, Single-Use, Single-Dose
- Wide dosing range: 0.3mL – 2.25mL (5mL or higher if required)
- Incorporates standard, 3rd party prefillable, glass syringes (1mL long, 2.25mL or 5mL standard); Drug Cartridge option can be made available
Key Benefits
- Can deliver highly viscous fluids (100cP demonstrated using a 2.25mL prefillable glass syringe)
- Compact Size (14.1 cm height, 2.4cm wide with a 2.25mL syringe)
- Passive Needle Safety Shield
- End of Dose Locking
- Hidden Needle at all times
- Enhanced Usability
- 2 Step use. Activation upon pressing against injection site
- Unique “Injection Pause™” Feature
- Visual and Audible indicators, novel dose tracking indicator
- Clear, large viewing window
- One-handed operation possible
Availability
- IP Protected
- Usability and Lab Testing Samples available
Congruence Injection Pause™ Technology and novel Visual Dose Progress Indicator
address premature removal from skin, increasing potential for full dose delivery
Applications
The Congruence Autoinjector is intended to enable drug delivery by a patient or caregiver in a home or other non-clinical setting.
The platform’s ability to deliver viscous drugs in a compact format means it is particularly suited to delivering high-dose (concentrated) biologic formulations found in oncology, autoimmune disorders, and other areas.
The platform is highly versatile and therefore also suitable for a wide range of drugs beyond just high-dose formulations. It’s versatility also enables use by Biopharma and Biotech customers across the drug lifecycle (including during drug development) and/or across multiple drugs in a portfolio.
Customize
The Congruence Autoinjector platform is designed with versatility in mind. The use of an alternative (non-spring) power source means that it can be readily customized to accommodate a wide variety of specific drug viscosities (100cP+), injection volumes (up to 5mL), target injection times and preferred needle gauges.
The autoinjector accommodates a choice of various ISO 11040 compliant standard glass syringes of size 1mL long, 2.25mL or 5mL. Use of a cartridge is possible for larger volumes. External Look and Feel can also be customized.
If you are interested in other customization and configuration options to meet your specific needs, please contact us
Specifications
| Key Needs Addressed | Viscous, Large Volume |
| Device Type | Autoinjector |
| User Profile | Caregivers, Patients, HCPs |
| Administration Route | Subcutaneous, Intramuscular |
| Primary Container | 1mL long, 2.25mL or 5mL standard prefillable glass syringe; Drug Cartridge option can be made available |
| Usage | Single Dose; Disposable |
| Dosage Type | Fixed |
| Dose Volume | 0.3mL – 2.25mL (or higher if required) |
| Viscosity | 100+cP |
| Injection Time | Customizable (typically <15 seconds) |
| Priming & Dose Setting | N/A |
| Needle Attachment | Pre-attached (staked-in) |
| Needle Safety | Integrated, Passive Needle Shield |
| Injection Feedback | Audible & Visual Indicators, Drug Viewing Window |
| Premature Removal Safety | Injection Pause Technology |
Instructions for use available upon request