Australian venture capital firms Brandon Capital and M.H. Carnegie & Co have completed a $60 million capital raise to clinically assess WiSE-CRT, the world’s first and only wireless cardiac resynchronisation technology (CRT) for heart failure.
The technology has been developed by US-based EBR Systems and is a wireless cardiac pacing system for heart failure.
The funds will be used to conduct a 350-patient clinical trial across Australia, US and Europe. The pivotal trial, following on from earlier promising clinical studies, intends to establish safety and efficacy in support of regulatory approval.
Australia will contribute an estimated 100 patients to the trial. Dr Prash Sander, Professor of Cardiology at the Royal Adelaide Hospital and a world expert on heart rhythm management, will lead the clinical trial in Australia, and sits on the steering committee for the global trial.
CRT is currently recommended for patients with worsening heart failure, and it works by synchronizing the contractions of the left and right ventricles of the heart. CRT improves heart failure symptoms, and consequently improves patients’ quality of life and reduces hospitalisations.
Conventional CRT requires wires to transmit pacing pulses to the heart. However, the wires cannot be placed inside the left ventricle, as it can cause clots resulting in heart attacks and strokes. As a result, these wires are typically placed outside the left ventricle, which is not ideal, and consequently up to 30 per cent of patients receiving conventional CRT do not respond to the therapy. This is a poor success rate for an invasive and expensive procedure. Each conventional CRT operation costs approximately $25,000.
EBR Systems’ WiSE technology is the world’s only wireless, endocardial (inside the heart) pacing system in clinical study for stimulating the heart’s left ventricle. It enables cardiac pacing with a novel implant that is roughly the size of a large grain of rice.
"The need for a pacing wire on the outside of the heart’s left ventricle, and the attendant problems, could be eliminated," said the companies in a statement.
“In terms of quality of life for heart failure patients, the difference between those that respond to CRT treatment and those that don’t, is like night and day,” said Dr Chris Nave, CEO of the Medical Research Commercialisation Funds (MRCF) and managing director at Brandon Capital. “Those that don’t respond to treatment can be so short of breath that they have difficulty completing even the most simple of daily tasks. Given the highly encouraging clinical data the Company has generated to date across a range of patient studies, including those patients that have previously failed to respond to conventional, wire-based CRT therapy, we believe EBR’s WiSE CRT system offers real hope to these patients.”
“Our investment strategy in medical devices is to target late stage companies, which are developing disruptive technologies that address multi-billion dollar markets. EBR’s WiSE Technology fits this strategy perfectly,” said Mark Carnegie, founding partner at M. H. Carnegie & Co.
Dr Nave added that Australia’s inclusion in the global trial reflects the country’s excellence in medical research. “Australia is extremely attractive for clinical trials because of its excellent research infrastructure, top-tier hospitals and leading clinicians. Government initiatives such as the R&D Tax Rebate, add significantly to Australia’s attractiveness as a destination for developing products like the WiSE Technology; creating jobs, growing our local industry and ultimately improving patients’ lives,” he said.