Congruence Medical Solutions LLC

The Flexible Dosing Syringe (FDS) platform enables easy dose setting at the point of use, and accurate, safe delivery over a wide range of injection volumes. Common applications include drugs requiring patient weight-based dosing or drugs requiring a microliter priming dose following by a larger milliliter therapeutic dose. Users can simply dial the dose volume that they require, and then manually deliver a single accurate dose of that volume (from 0.01mL to 2.2mL).

The FDS is easy to use and has a proprietary passive needle safety technology. This makes it suitable for self-administration or delivery by a clinician. This versatile platform incorporates standard pre-fillable syringes and has a wide array of customization options.

  • Disposable, Single-Use, Single-Dose
  • Variable, user-set dose volume across wide range (0.01mL – 2.25mL)
  • User controls injection speed
  • Dose setting options: Pre-set (factory-set) or User-set
  • Drug filling options: Pre-filled
  • All options incorporate standard, third-party, ISO 11040 compliant, pre-fillable syringes

Key Benefits
  • High accuracy: +/-2.5μl
  • Congruence proprietary passive needle safety technology
  • Easy to Use
    • Air-Priming & Dose-Setting in one simple step
    • Easy dose dialing
    • Clear display of dose volume
    • Visual indicator confirms full dose delivery
    • Large drug viewing window
    • One-handed operation possible
    • Can deliver viscous drugs

  • IP Protected
  • Samples available for clinical/preclinical use

The FDS platform is designed for applications where the injection volume needs to be selected at the point of use, either by a clinician, caregiver or by the patient (self-injection).

Key applications include therapies where the injection volume is based on patient weight (for example, with pediatric dosing) or other biomarkers. It is also suitable for oncology applications where dose loading is required. The FDS can help reduce the number of SKUs where otherwise different pre-set dose presentations would be required.

The FDS can also streamline and reduce the cost of clinical trials that involve dose escalation studies by avoiding reformulation of different strengths of the same drug and/or use of multiple devices for different dose volumes.

Several customization options are possible with the FDS platform:
  • Pre-filled (syringe is primary drug container)
  • Choice of various ISO 11040 compliant standard syringes:
    • Siliconized, silicone-free or lubrication free
    • 1mL long, 1mL short, 2.25mL, 5mL, 10mL; Glass or polymer
    • Luer-lock or staked needle
  • Injection volume range from microliters through maximum nominal capacity of syringe
  • Dose volume values and volume increments
  • Accommodation for different drug viscosities
  • External look and feel
  • Other based on route of administration
  • Locking of plunger rod at end of dose

If you are interested in other customization and configuration options to meet your specific needs, please contact us.
The FDS has been shown to deliver accurate, precise doses at various target volumes from 0.2mL to 2.0mL1

Additional data available upon request

Key Needs Addressed Wide volume range (Microliter through Milliliter), Variable-Dosing
Device Type Manual Syringe Injector
User Profile HCPs, Caregivers, Patients
Administration Route Subcutaneous, Intramuscular
Primary Container 1mL long, 1mL short, 2.25mL, 5mL and 10mL standard prefilled glass syringe
Usage Single-Dose; Disposable
Dosage Type Variable, User set
Dose Volume 0.01mL – 10mL
Viscosity Up to 100cP
Injection Time User Controlled
Priming & Dose Setting Simple Dial Turn, Passive priming
Needle Attachment User attached [Luer-lock] or Pre-attached [staked]
Needle Safety Passive Needle Shield, Integrated needle safety for staked needle PFS
Injection Feedback Drug Viewing Window, additional visual and audible indicators.
WP DataTables

Instructions for use available upon request

1 Congruence study data