Individuals with serious heart disease can spend months waiting for a compatible donor organ but that may change when Queensland-born med-tech company BiVACOR receives regulatory approval for an artificial heart that’s been two decades in the making.
The BiVACOR heart is a mechanical device that can replace a mammalian heart. It uses a single spinning disk, suspended in a magnetic field, to pump blood around the body and back to the lungs.
Unlike other mechanical hearts already in clinical use, it’s designed to be a lifelong solution, not a stopgap device to keep patients alive until a compatible donor organ becomes available.
Headquartered in the US and with an international office in Queensland, BiVACOR secured $22 million in its latest round of venture capital and grant funding in April 2021. That money will be used to take its prototype through the US Food and Drug Administration’s stringent verification process.
Obtaining approval and getting the device into the hands of surgeons – and the chests of patients – will be a watershed moment for BiVACOR founder Daniel Timms, who’s been exploring the workings of the human heart since 2000.
“At that time, I was studying mechanical engineering at QUT and thinking about what I’d do with my degree when my father was diagnosed with heart failure,” Timms explains.
“I wanted to figure out a way I could help sufferers like him in the future. Dad was a plumber and we started kicking ideas around together and building prototypes with components we bought at Bunnings. We were pumping water rather than blood but, as far as we were concerned, it was still pressure and flow.”
With support from cardiac specialists at Brisbane’s Prince Charles Hospital, Timms made the artificial heart the subject of his PhD in Biomedical Engineering and subsequent post-doctoral research.
A fellowship at the Texas Heart Institute in 2012 connected him with pioneering transplant surgeons who helped secure funding to kickstart the commercialisation process and transform Timms’ brainchild into a fully fledged business.
Bringing such a complex, critical device to market has taken many years and more than a modicum of faith, for Timms and his now 18-strong team of engineers and clinicians.
“When you remove someone’s heart, there’s no going back,” Timms says. “An artificial heart has to do everything reliably and well – the onus is on us to demonstrate to the FDA that we’ve developed a safe device before they allow us to bring it to the first patient.”
He’s cautiously optimistic that will happen in late 2022.
And when it does, it may well put paid to lengthy transplant queues and complex and expensive post-transplant immuno-suppressant medical regimens.
“There’s no blood type or size to match – the BiVACOR heart is an off-the-shelf, one size-fits-all product,” Timms says. “We believe it will help to get patients with heart failure out of hospitals and back living relatively normal lives.”
BiVACOR is a member of Life Sciences Queensland, the peak body that provides pathways for stakeholders to collaborate, build their businesses and develop an internationally competitive life sciences industry in Australia.
LSQ Chief Executive Clare Blain says the company is an extraordinary example of what’s possible when purpose, passion and persistence intersect.
“Med-tech ventures like BiVACOR will change lives for the better, here in Australia and around the world,” Blain says. “It’s a privilege for LSQ to be part of that journey and we salute the vision and commitment of Daniel and his team.”