The technology has been developed by 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 U.S. Food and Drug Administration approval. If successful, EBR’s WiSE system will become available to patients in these countries.
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 percent 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. The high failure rate means more than $1.3b of $3.8b spent globally on CRT devices annually provides no patient benefit.
By comparison, 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. This has long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location. WiSE addresses these problems by enabling 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.
“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,” says 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.” The investment by Brandon is being made out of the MRCF3 Fund.
“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,” says Mark Carnegie, Founding Partner at M. H. Carnegie & Co.
Trevor Moody, Partner at M. H. Carneghie & Co, says, “As a former pacemaker engineer and long-time medical device investor, I am excited to back EBR Systems and its WiSE Technology for wireless endocardial stimulation. I am convinced that wireless pacing represents the future of cardiac pacing and that EBR Systems is at the forefront of this technological advancement.”
Australia will contribute an estimated 100 patients to the trial which will run across 10 hospitals, six of which are research members of the MRCF. Prash Sanders, MD, PhD, Professor of Cardiology at the Royal Adelaide Hospital and a world expert on heart rhythm management, will lead the clinical trial in Australia, and also sits on the steering committee for the global trial.
Dr Nave says 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.”
In addition to M.H. Carnegie & Co and Brandon Capital Partners, the financing includes participation by a number of noted US investors who are current shareholders of the company: Split Rock Partners, Ascension Ventures and Dr. Thomas Fogarty’s Emergent Medical Partners.