Software-linked drugs

A new category of medicine.

Dosing software named in the FDA-approved label - developed, submitted, and reimbursed as a drug. Built with the people who helped write the regulatory science.

Explore the platform

Personalized
dosing system

Software in
the drug label

Regulatory
pathway

Translational Cures Platform

The problem

AI is speeding drug discovery.

However, 9 out of 10 drug candidates
get stranded in clinical trials.

Drug Discovery Pre-Clinical Clinical Trials FDA Review
& Approval

↑ Ai Speeds
Discovery

↑ 9 of 10
Drug candidates get
stranded in clinical trials

The Innovation

Platform-enabled value step-up for
stranded Phase 2 and 3 drugs.

How it Works

The drugs that win get more patients into the therapeutic window.

The winning product
isn't always the
strongest molecule.
It is the one that reliably reaches the window.

Founder & CEO

David Strauss, MD/PhD

14+ years at the FDA
9Y FDA Center for Drugs
5Y FDA Center for Devices
1Y FDA Acting Chief Scientist

The Old Way

One Size Fits All Dosing
Variability among patients in benefit-risk
Larger trials required to demonstrate efficacy

Our Way

Model Informed Precision Dosing
Smaller, faster clinical trials to demonstrate efficacy
Fewer safety failures

The Platform - Category Made Concrete

Put the dosing system inside
the FDA-approved drug label.

Cardiacures®

A SOFTWARE-LINKED DRUG IS

Drug-device combination product
Submitted through an NDA
Commercialized as a drug
Reimbursed as a drug

01 INDICATIONS AND USAGE

02 DOSAGE AND ADMINISTRATION Approved dosing algorithm lives here

03 DOSAGE FORMS AND STRENGTHS

04 CONTRAINDICATIONS

05 WARNINGS AND PRECAUTIONS

06 ADVERSE REACTIONS

07 DRUG INTERACTIONS

08 USE IN SPECIFIC POPULATIONS

The Pathway

A fast, FDA-aligned path via model-informed
drug development (MIDD).

Small clinical
trial

02 Model-Informed Drug Development

In silico clinical
trial

Evidence of safety & effectiveness in NDA

Why Cardiovascular

Cardiovascular is the ideal first arena.

Narrow therapeutic
windows.

High patient variability.
Monitorable biomarkers.

Large, undertreated
populations.

Contact

Invest or Partner

Could the Translational Cures platform add value to your asset?