The tiny organ’s creator, Medera Biopharmaceutical, hopes that this powerful tool can reshape how drugs are tested and dramatically speed up the time it takes to bring them to market.

Stem cell research has become increasingly common in the pursuit of pharmaceutical treatments for heart disorders and other diseases.

But Hong Kong and US-based Medera says it has gone a step further with a self-sustaining miniature heart that produces more reliable results than testing new treatments on animals, at a lower cost.

“This really will allow us to, number one, study a human condition that is very difficult to model in animals,” said Medera co-founder Ronald Li.

“Number two, we’re able to fast track a rather lengthy process.”

Traditionally, a new drug could cost a pharmaceutical company roughly US$1 billion and take eight to 10 years to develop and test.

Roughly 90% fail to make clinical trials, largely due to negative side effects.

Medera’s “heart in a jar” technology aims to shrink drug development timelines to as little as two years while cutting costs in half, including by replacing animal testing, Li told Nikkei Asia.

The idea is to take tissue from a living person and create the minihearts which can be used to test a treatment’s toxicity on healthy organs or alter it to mimic cardiac illnesses so pharmaceutical companies can gauge the real-world efficacy of a new drug.

“I think the ability to personalize is extremely powerful. Now you can think about having, a Chinese, southern Chinese, northern Chinese, Jewish, Caucasian (heart). And not only healthy individuals, but also sick individuals who carry particular genetic mutations,” said Li, who also founded the Stem Cell & Regenerative Medicine Consortium at the University of Hong Kong.

The start-up, founded in 2014, said it has now created more than 300 minihearts, which are installed in a proprietary device that gives them a regular heartbeat.

The process takes over two months to create a heart.

Medera has so far received grants of more than US$100 million from universities and organisations including the American Heart Association and Hong Kong’s Innovation & Technology Commission.

The biotech company has signed a memorandum of understanding with AstraZeneca to focus on developing cardiac drug therapies for patients with a serious condition known as “preserved ejection fraction” – when the heart’s left ventricle doesn’t properly fill with blood.

In the US and European Union there are roughly 12 million patients suffering from heart disorders, and “if you take China into consideration, we likely will be seeing double that number”, Li said.

There is no official public information on the Chinese data.

Medera’s ambitions don’t stop at minihearts, however.

The company’s 100 research and development staff have been working on expanding a line of other miniature organs, including livers, kidneys and lungs, in a bid to improve targeted therapies and drug trials.

The biotech company is also working with leading universities on tweaking Covid-19 treatments to reduce side effects like myocarditis, a kind of heart inflammation linked to coronavirus mRNA vaccines.

Marketing these miniature organs to drug companies for testing is a crucial part of Medera’s effort to generate sustainable cash flow.

And the company has also created a portfolio of two dozen preclinical and clinical therapies that could be licensed out to generate revenue.

Currently there are 10 ongoing trials of different cardiovascular gene therapies, with three treatments expected to reach the final stages by next year.

The company, ultimately, will work toward an asset-sharing and revenue-sharing model.

Kenneth Wong, vice-chairman of Medera, said there was already some revenue flowing in from those collaborations, but he declined to discuss numbers or say which drug companies were part of the collaborations.

Capital-raising plans are also underway with an eye to a possible Hong Kong listing, Wong said.

“We are starting the strategic investment process,” Wong told Nikkei Asia.

“We’re hoping that we can actually advance our technology and our products together with (investors).”