For decades, pharmaceutical companies have used animal testing and clinical trials to determine the effectiveness and safety of new drug formulas.
But these methods have proved to be costly, dangerous and highly inefficient. To fix this, global biotech firm Novoheart has developed the world’s first miniature beating human hearts using stem cells.
Founded by Ronald Li, Kevin Costa and Michelle Khine in 2014, it’s on a mission to transform the medical industry by offering a new standard for precision testing that delivers unprecedented time and cost savings.
“Drug development has traditionally relied on cell cultures and small animal models for predicting cardiac toxicity and efficacy,” says Kevin Costa, Chief Scientific Officer of Novoheart.
“But they are not especially predictive of how a drug will ultimately behave when it’s delivered to human patients, and both the pharma industry and regulatory agencies have been actively seeking better alternatives.”
A pioneering alternative
After 20 years of pioneering research, Costa, Li and colleagues have demonstrated a fully functioning miniature “heart-in-a-jar” solution that can predict how drugs might react in a human patient.
It replicates one of the four main chambers of the human heart, with a wall thin enough that it doesn’t require a blood supply. “With this advanced 3D model, we are able to reproduce some of the key responses to mechanical loading, electrical stimulation, and drug treatments,” explains Costa.
“We have been able to make healthy mini hearts for detecting potential cardiotoxic effects of drugs. We have also made diseased hearts carrying specific genetic abnormalities, in partnership with pharmaceutical companies that are designing drugs for treating the disease but have not had models that adequately mimic the human symptoms for testing their new therapeutics.”
In addition to the miniature heart, the firm has created a suite of complementary human stem cell-derived cardiac assays called the MyHeart Platform. Using these technologies, experts get insights into the impact drugs may have on the heart. They can detect beneficial effects or dangerous, potentially life-threatening adverse reactions – like irregular heart rhythms.
Costa believes these solutions can revolutionize medicine by making therapies safer and more effective for patients, as well as reducing the wasted investment of resources. “Overall, we are witnessing an industry-wide trend to explore human stem cell-based assays as a move away from traditional animal testing,” he says.
Among the company’s early successes, it’s not only demonstrated the miniature beating heart model but has also been listed on Canada’s TSX Venture Exchange. However, Costa admits that Novoheart has had to overcome many challenges. He says: “One hurdle we are facing is the time that the pharma industry needs to adopt new technologies, but we understand that this requires persistence while we continue to deliver high-quality science and boundary-pushing innovation.”
A bright future
Looking to the future, Costa says Novoheart will continue to refine its technologies and invest in further research. “For example, we have developed a modular bioreactor which allows us to monitor multiple mini-hearts, or cardiac organoids, at once,” he continues.
“This can potentially be extended to mini-organs other than the heart, which can be connected together to simulate interactions at the systems level between the heart and other organs in the body. If we ultimately want to realize the potential for replacing animal studies with human-based organoids, then there will be a need to create systems comprising different organ types.”
At its R&D facilities in California, Novoheart is actively developing new hardware and software that interface with its engineered human heart tissues. The aim is to enhance the throughput, sensitivity and accuracy of the biological assays.
“As the assays become more sophisticated, the data sets we generate increase in size and complexity, which require extensive mining to fully utilize the highly valuable recordings made with these tissues,” concludes Costa.
“We have developed machine learning algorithms to analzse the data in an unbiased and comprehensive way, to maximize the information we can derive efficiently and effectively from these assays. Our next-generation smart assays promise to be even more powerful than they are now.”