Congruence Autoinjector with Injection Pause™ Technology

The Congruence Autoinjector is a next generation disposable autoinjector platform, designed for self-injection applications. It utilizes a proprietary compressed-gas power source, making it compact yet powerful for delivery of high-dose formulations that are of higher viscosity and/or larger volume. It also incorporates novel usability features to mitigate well-known autoinjector user errors, such as Injection Pause™ technology which addresses premature removal from the skin prior to end of dose.




The Congruence Autoinjector has significant advantages over currently available legacy devices, enabling it to meet the current and future needs of patients and the biopharma market. It offers:

1. ENHANCED USABILITY, and in particular addresses the perennial issue of premature removal from skin
2. HIGH FORCE CAPABILITY to rapidly deliver larger volume (2mL and greater) and/or higher viscosity (30 to 100+cP) drugs and/or through fine injection needle
3. GREATER VERSATILITY - suitable not just for higher viscosities and larger volumes, but also “standard” viscosities and volumes
4. EASIER CUSTOMIZATION for faster, lower risk device development
5. INCORPORATES STANDARD PRIMARY CONTAINERS, such as standard glass or polymer pre-fillable syringes
6. SUSTAINABILITY ALIGNED, through compact size reducing materials, supply chain costs, and minimizing drug waste with Injection Pause feature

APPLICATION AREAS

The Congruence Autoinjector platform is designed to have broad suitability across a wide range of self-injection drugs (volume, viscosity) and broad patient populations (autoimmune, oncology, neuro, dermatology, etc.). The platform’s ability to deliver viscous drugs and/or larger volume doses means it can be used for delivering high-strength biologic formulations. As the platform can be easily customized, it is suitable for use across the drug lifecycle (including during drug development) and/or across multiple formulations or drugs in a portfolio.




KEY FEATURES

The Congruence Autoinjector has several key features that combine to provide a unique combination of benefits in one platform:




1. ENHANCED USABILITY:

• INJECTION PAUSE feature stops an injection if the device is removed from skin before end of dose, ensuring no drug is lost, and the VISUAL DOSE PROGRESS INDICATOR indicates the dose remaining. The patient can then have an informed conversation with their HCP and/or continue to dose completion, as the Pause feature allows needle reinsertion and for the injection to resume.
• HIGH FORCE DELIVERY. Can rapidly deliver larger volume (2mL and greater) and/or higher viscosity (30 to 100+cP) drugs and/or through fine injection needle. Shown to deliver 2mL 100cP solution in 15 seconds from a 2.25mL glass PFS with a 27G staked needle.
• 2-STEP USE (Push-on-skin actuation), with PASSIVE NEEDLE SAFETY
• IMPERCEPTIBLE ACTUATION AND RECOIL FORCES. A Congruence user study showed these forces were imperceptible and well accepted.
• COMPACT SIZE. The 2.25mL Congruence Autoinjector (14.1 cm height, 2.4cm wide) is the same height or smaller than current 1mL Autoinjectors. ENABLING RAPID DEPLOYMENT

2. INCORPORATES STANDARD PRIMARY CONTAINERS - glass or polymer prefillable syringes or cartridges




3. VERSATILE PLATFORM. The proprietary power source can be readily adjusted to deliver a range of different drug viscosities and volumes. Furthermore, the same form factor could be used for both 1mL and 2.25ml PFS.




4. RAPID CUSTOMIZATION lowers risk device development, minimizes the time and cost of customizing injection time, syringe (or cartridge) size and drug fill volume.




5. ALIGNED WITH SUSTAINABILITY OBJECTIVES

• COMPACT SIZE enables reduced transportation costs and a smaller footprint in the drug cold chain
• INJECTION PAUSE feature ensures that drug is not wasted upon inadvertent, premature autoinjector removal from the injection site.