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Sunshine for heart failure
19 / 05 / 2011
Many a company has stumbled chasing the elusive dream of making an artificial heart or a small pump to provide some assistance to those whose heart is failing.
Australia's Ventracor, which envisaged a pump to replace the crucial million left ventricle or chamber of the diseased heart , collapsed during the global financial crisis. As investors preferred to fund later stage businesses rather than riskier start-ups.
Now a second Australian company, Sunshine Heart, has re-emerged with plans to take its inherently less risky heart assist device into clinical trials.
Sunshine Heart's C-Pulse pump, unlike competitors under development or in the market, is not implanted in a patient's blood stream, requiring major and risky open heart surgery. Instead, a simple balloon is wrapped round the aorta as it emerges from the heart, with an air supply used to inflate and deflate the device and help the heart in its job of pumping blood round the body.
The first generation C-Pulse is powered from an external battery and pump connected to the balloon through a hole between the ribs.
The device has been implanted in 20 people in trials in the United States. Results are due in September and Sunshine Heart chief executive Dave Rosa has accelerated the development of a fully implantable device which gets its power from radio waves from an external source.
"We expected to have to spend a lot more time to develop the method of transmitting power through the skin," Rosa says on a visit to Australia to provide a progress report to investors. "But a few things are happening a little sooner than we expected."
The implantable device is likely to be ready in August and a $35 million plus study of 270 patients is planned to begin next year.
This means approval to market a device in the United States could not come before about 2015.
Sunshine Heart has already raised more than $65 million from investors and, while it is being paid $US52,000 for each device implanted in the US, will need to raise funds to cover the cost of the trials and product and market development.
"If you have a sales representative that sells 20 systems a year it doesn't take long for this to become profitable," Rosa says. "But we have to be careful to maintain our focus [while developing marketing capability]."
As Sunshine Heart has done the hard yards developing its device, shares have doubled to about 5 cents, valuing the business at $54 million.
But there will be a lot more milestones, risks and time before investors can be confident that Sunshine Heart won't go the way of Ventracor.
To this point the company has a credible product, some proof of safety and a potentially large market of victims of heart failure.
"The biggest risk was the feasibility trial," Rosa says. "Now the things we need to accomplish are really in our control. You always feel better that way."