If you are a gene therapy developer dealing with the limitations of electronic implants — this project developed BradyTx-01 that reprograms cardiomyocytes into pacemaker cells. This allows for a minimally invasive delivery of a potentially lifelong cure.
Biological Pacemaker Gene Therapy to Replace Electronic Cardiac Implants
Imagine if instead of inserting a battery-powered device into the heart, we could simply teach the heart to fix itself. This technology uses a viral delivery system to rewrite the instructions of regular heart cells, turning them into natural pacemaker cells. It creates a living heartbeat regulator that grows and adapts to the body's needs without needing surgery to replace batteries.
What needed solving
Current cardiac pacemakers rely on electronic implants that require invasive surgery, battery replacements, and cannot naturally adapt to a patient's metabolic needs.
What was built
A gene therapy medicinal product (BradyTx-01) and a bioreactor-based manufacturing process for AAV vectors.
Who needs this
Who can put this to work
If you are a cardiac implant manufacturer dealing with the high cost of battery replacements and device failures — this project developed a biological pacemaker that responds to metabolic demand. It offers a transition from hardware-based pacing to cellular reprogramming.
If you are a CDMO dealing with the difficulty of scaling viral vectors for cardiac use — this project developed a bioreactor-based manufacturing process to scale up production from petri dishes to porcine-level volumes.
Quick answers
What is the estimated cost or price of the therapy?
Based on available project data, the specific cost per treatment is not provided; however, the project is currently conducting health technology assessments to define its value proposition.
Can this be produced at an industrial scale?
Yes, the project has established a bioreactor-based manufacturing process to scale up production from small-scale petri dishes to levels sufficient for porcine studies.
What is the IP and licensing status?
Based on available project data, the technology is developed by PacingCure B.V., but specific licensing terms or patent numbers are not listed in the summary.
What regulatory hurdles are being addressed?
The project is actively evaluating regulatory strategies and conducting health technology assessments to guide the transition toward clinical trials.
What is the development timeline?
The project period runs from 2023-01-01 to 2025-12-31, focusing on preclinical validation in mice, pigs, and non-human primates.
Who built it
The consortium is a lean, 2-partner collaboration based entirely in the Netherlands, consisting of one SME (PacingCure B.V.) and one research entity (AUMC). With a 50% industry ratio, the structure is designed for rapid transition from academic research to a commercial entity, focusing heavily on the 'technology-product-market fit'.
Contact PacingCure B.V. in the Netherlands
Talk to the team behind this work.
Contact us to explore licensing opportunities for biological pacemaker technology.