A repeatable, efficient
development pipeline.

Hub & Spoke Model

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CardiaCures is developing
a multi-drug pipeline.

On the Translational Cures platform.

Explore the platform
CardiaCures Pipeline

The Pathway

A repeatable, efficient
development pipeline.

01 Model-Informed Drug Development
In silico clinical trial

In silico clinical
trial

02
Small clinical trial

Small clinical
trial

03
FDA

Evidence of safety & effectiveness in NDA

Pipeline Table

Programs across one architecture.

Existing
Clinical Data
> Modeling &
Simulation
> FDA (MIDD)
Engagement
> Small
Confirmatory
Patient Trial
> New Drug
Application
Priority Assets
CC-001
Planned Targeted submission 2028
CC-002
Planned Targeted submission 2027
Additional Assets
CC-003
CC-004
CC-005

Integrated Product

Differentiated, non-substitutable products.

01

Modified-release formulation, new strengths

+
02

Precision dosing software

+
03

Wearable feedback

CC-001 DETAIL

CC-001 · Atrial fibrillation rhythm control.

The Evidence

FDA · MIDD Path

CC-002 · Inherited arrhythmia — first NDA path.

The Evidence

  • 01
    Small-molecule antiarrhythmic in a genotype-confirmed population
  • 02
    Model-informed precision dosing + model-informed drug development
  • 03
    FDA engaged on targeted phase 3 trial plan

Path to first NDA

  • 01
    Orphan eligible 505(b)(2) NDA pathway
  • 02
    Clinical data already generated on the approach
  • 03
    First NDA submission targeted 2027 — the fastest path

Detailed development packages under confidentiality.

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