The discovery and development of novel drugs and therapeutics for heart diseases continues to be an unacceptably inefficient process. A major reason has been due to the lack of appropriate human models to simulate the normal and pathological human heart. Traditional animal models such as rodents, dogs and pigs are accessible but major species differences in the cardiac anatomy and function exist. What works in animals may be ineffective or even lethal in humans.
Development of drugs and therapeutics is both risky and costly. Numerous drugs have been withdrawn from the market because of adverse clinical side effects and risks to patients. Cardiotoxicity is a common leading cause, even for drugs not for the heart. As an example, in the Cardiac Arrhythmia Suppression Trial (CAST) conducted between 1986 and 1998, several “anti-arrhythmics” were found to unexpectedly increase mortality by causing lethal arrhythmias after testing in over 1700 patients. With Novoheart’s proprietary technology, the pro-arrhythmic properties of failed CAST drugs such as flecainide could be readily detected, with assessed risks comparable to what was clinically observed (Shum et al 2016, Advanced Materials).
In addition to patient health, a single drug withdrawal typically costs 10+ years and an economical investment of USD2-3 billion. Not only does an early detection minimize potential patient harm, it also enables resources to be focused on post-discovery fine-tuning for maximizing benefits and successes.
A heart is a heart; cells are not an organ. Although pharmaceutical companies have become increasingly interested in using human stem cells and/or their derivatives for screening, conventional tests are typically conducted with 2D cell cultures; there are some 3-D systems available but NONE reproduces the 3D chamber architecture and pumping capability seen in our native heart. Novoheart’s bioengineering technology platform allows a range of clinical parameters to be readily measured, without human subjects. Our “human-heart-in-a-jar” is therefore not merely clinical-trials-in-a-dish. Indeed, our system could also uniquely serve as prototypes for next-generation transplantable grafts for regenerative heart therapies.