Worldwide at least 26 million people have heart failure, and the number is growing, according to research. It’s a devastating diagnosis—where, as the name implies, the damaged organ no longer functions properly and can’t pump enough blood to meet the body’s needs. The progressive condition is incurable and can rapidly turn fatal.
“About 50% of patients die within five years. It’s worse than (most forms of) cancer really,” said Stuart Plant, CEO of Ceryx Medical.
But the Cardiff-UK health tech startup has an ambitious aim to change that.
Ceryx announced Wednesday that it raised £3.8 million, or the equivalent of nearly $4.8 million, to commercialize and fund the first human trials of a technology that the company and its investors see as potentially lifesaving for people with heart failure. Icehouse Ventures, the Development Bank of Wales, Parkwalk Advisors, Business Growth Fund and a consortium of angel investors provided the funding.
Ceryx’s device, Cysoni, is designed to pace the heart in rhythm with a person’s respiration, so heart rate and breathing are synced. This is typically the case for a healthy person, but for someone with heart failure that link becomes severed, Plant said.
“If we could restore the link between the heart and lungs in patients with heart failure, we could make them better,” he said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Preclinical studies of the technology in animal models (namely, sheep with heart failure) have found that not only does the device restore heart function, increasing the amount of blood the organ is able to pump, but it is able to repair damaged heart cells. If Ceryx is able to replicate those findings in people, it could eliminate symptoms of heart failure and allow the heart to repair itself, Plant said.
“Essentially you might eventually get a complete reversal of the damage to the heart and cure heart failure,” Plant said. “That’s quite a big claim. But that’s what the early data suggests.”
At present, there is no device or treatment that can halt the progression or reverse damage to the heart associated with heart failure. Traditional pacemakers act like a metronome, keeping the heart at a certain rate of beats per minute, and can be effective in addressing an irregular heart. But Plant contends by going beyond the heart alone, and synchronizing it heart rate with breathing, Ceryx’s technology will be more effective at restoring function and repairing damage to the organ.
“It’s listening to what the body does and times the heart to improve its efficiency and make the heart work properly,” he emphasized. “The big difference is this is what our heart and lungs naturally do.”
Plant expects to begin recruiting participants for human trials, which will take place in the United Kingdom and New Zealand, around the beginning of next year. Ceryx’s ultimate aim for Cysoni is to make it an implantable device, though it could also license the technology for use in another device maker’s pacemaker.
For the purposes of studying it in people, Ceryx will use an external pacemaker device, and load it with the company’s technology. This will be used to pace the hearts of patients with heart failure who’ve undergone a coronary artery bypass, Plant explained. This kind of pacing is typically done in the hours immediately after bypass surgery. But Plant said with the trial, that pacing will happen the entire time participants are in the hospital to get a better sense of what the technology can do.
That will determine if the technology lives up to the early promise.
“We’re hugely impressed with the progress made by Ceryx Medical,” said Richard Thompson, senior investment executive at the Development Bank of Wales. “The lifesaving potential of Cysoni and related developments can’t be overstated and we’re eager to see how Ceryx’s technology performs.”
Photo: BrianAJackson, Getty Images
