CardiaCures
CardiaCures develops software-linked drugs that combine model-informed precision dosing with antiarrhythmic therapies, enabling personalized, at-home management of atrial fibrillation. The company's dosing software is named in the FDA-approved label and is developed, submitted, and reimbursed as a drug itself. CardiaCures targets its first NDA submission in 2027 for an inherited arrhythmia program using an orphan-eligible 505(b)(2) pathway.
- Drug Discovery & Therapeutics
- Healthcare Technology
- Digital Health
- Software Only
Funding
Founders
Founder details are not available yet.
Product
Problem
Effective antiarrhythmic drugs for atrial fibrillation exist but have a narrow therapeutic window, requiring patients to be hospitalized for three days when starting certain medications. Many patients and doctors avoid these drugs due to the hospitalization burden, and one-size-fits-all dosing fails to account for variability in patient benefit-risk profiles.
Solution
CardiaCures develops software-linked drugs that combine model-informed precision dosing with antiarrhythmic therapies, enabling personalized, at-home patient management. The company's dosing software is named in the FDA-approved label and is developed, submitted, and reimbursed as a drug. CardiaCures uses a hub-and-spoke model built on the Translational Cures platform, leveraging in silico clinical trials and small confirmatory patient studies to demonstrate safety and effectiveness. The company is developing a multi-drug pipeline for atrial fibrillation with a go-to-market in an inherited arrhythmia, targeting FDA submissions in 2027 and 2028.
Target Audience
Primary customers are atrial fibrillation patients who need antiarrhythmic therapy without hospitalization, and the clinicians who treat them. The company also targets regulatory pathways through FDA engagement to bring model-informed precision dosing to market.
Features
- Model-informed precision dosing software named in the FDA-approved drug label, developed and submitted as a drug itself
- Multi-drug pipeline covering atrial fibrillation rhythm control and inherited arrhythmias, with priority assets CC-001 and CC-002
- FDA engagement through the model-informed drug development (MIDD) program, including model validation and in-silico safety trials
- Integrated product combining modified-release formulations, precision dosing software, and wearable feedback
- Hub-and-spoke development model on the Translational Cures platform enabling repeatable, efficient drug development
- Orphan-eligible 505(b)(2) NDA pathway for inherited arrhythmia program with clinical data already generated