The US-based company will use the funds to complete the clinical study of its WiSE CRT System, aiming to get FDA approval in 2023
WiSE technology facilitates pacing of the left ventricle. (Credit: StockSnap from Pixabay.)
Silicon Valley-based pacemaker start-up EBR Systems has raised A$110m ($80m) through an initial public offering (IPO) in Australia.
The company intends to use capital raised in the IPO, which is supported by new and existing institutional shareholders, to complete the clinical trials of its WiSE CRT System.
The leadless pacemaking technology firm aims to use the study results to obtain the US Food & Drug Administration (FDA) approval in 2023, and commercialise the product in the US, Australia and other markets.
EBR Systems president and CEO John McCutcheon said: “It’s been wonderful to see such strong investor support for EBR’s initial public offering.
“With Australia’s long tradition as a global innovator in cardiology technology, it is fitting that Australian investors will provide the financial backing as we pioneer leadless LV pacing so that it can help to improve the lives of heart failure patients in Australia and around the world.”
According to the company, most of the patients with heart failure require cardiac resynchronisation therapy (CRT), which involves lead-based cardiac pacing devices.
Lack of effective CRT is expected to result in patients suffering from poor clinical prognosis, poor quality of life and reduced life expectancy.
EBR said that its WiSE CRT System is the world’s first and only wireless, endocardial left ventricle pacing system for heart failure, and is approved for use in Europe.
WiSE technology is designed to facilitate cardiac pacing of the left ventricle with an advanced cardiac implant that is around the size of a large rice grain.
The system provides a treatment option for patients who are not eligible to receive CRT from a traditional lead-based system, or at high-risk from an upgrade procedure.
Furthermore, EBR estimates that its WiSE technology platform can be used and extended into other patient groups.