Application
Non-viral gene delivery and a small molecule that converts heart muscle cells to pacemaker cells for the device-free treatment of slow heart rhythm.
Key Benefits
- Minimally invasive procedure provides cardiac pacing without device implant.
- Restores natural heart rhythm.
- Eliminates or reduces significant complications such as repeat surgeries for device exchange or infected indwelling devices.
- Provides alternative treatment for pediatric patients.
Market Summary
Cardiac arrhythmia is an irregular beating of the heart. Changes from the normal sequence of electrical impulses may cause the heart to beat too fast, too slowly, or erratically. Heart beats, or contractions, originate from the sinoatrial (SA) node, also referred to as the “Natural Pacemaker.” To correct irregular heartbeats, artificial pacemakers are often implanted. It is estimated that more than 500,000 pacemakers are implanted each year globally. There are several drawbacks of artificial pacemakers, including risk of infections, dislodging of lead wire, battery replacements, and the fact that placement of transvenous leads is mostly irreversible. There are also no pediatric-sized pacemakers available.
Technical Summary
Emory University researchers have engineered biological pacemakers for device-free, cardiac pacing. Free of all hardware, the biological pacemaker consists of a natural human gene, TBX18, combined with a small molecule. The biologic is formulated without using viral vectors, and converts ordinary cardiac muscle cells into pacemaker cells. The team has shown in preclinical animal models that transient activity of the biologic suffices to create new pacemaker cells, which, in turn, generated device-free and durable cardiac pacing. Delivery of the biologic is minimally-invasive and can be performed in routine outpatient procedure. This technology can be introduced as a tandem to an electronic pacemaker in which a biological pacemaker functions to restore natural heart rhythm while the electronic device serves as a backup.
Developmental Stage
- Small animal proof-of principle study completed.
- Clinically-relevant large animal validation studies are underway.
Publications
Kapoor, N. et al. Nature Biotechnology 31 (2013): 54–62.
Hu, Y. et al. Science Translational Medicine 6.245 (2014): 245.
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