• EBR Systems’ WiSE™ CRT System is world’s first and only wireless endocardial (inside the heart) left ventricle pacing system for heart failure
  • EBR’s AU$110m ASX initial public offering today was strongly supported by new and existing institutional shareholders
  • The new capital funds the completion of pivotal study, targeting FDA submission for approval in 2023 followed by rapid U.S. commercial launch

SUNNYVALE, Calif.--(BUSINESS WIRE)--Australian investors’ strong appetite for healthcare stock continues with the AU$110M listing of cardiovascular medical device company, EBR Systems, at 11am AEDT November 24 on the Australian Securities Exchange (ASX).

Silicon Valley-based EBR Systems is pioneering leadless pacemaking technology. The company’s WiSE™ CRT System is the world’s first and only wireless, inside-the-left-ventricle-of-the-heart pacing system for heart failure, and is approved for use in Europe.

Capital raised from next week’s listing will provide EBR Systems with the equity to complete its pivotal study, targeting U.S. Food & Drug Administration (FDA) submission for approval in 2023, followed by rapid commercial launch in the U.S., Australia and other key markets.

Many patients with heart failure require cardiac resynchronization therapy (CRT), which uses lead-based cardiac pacing devices to coordinate the beating of the left and right sides of the heart. WiSE provides a treatment option for patients unable to receive CRT from a traditional lead-based system or those at high risk from an upgrade procedure. Without effective CRT, these patients suffer poor clinical prognosis, poor quality of life and reduced life expectancy.

“It’s been wonderful to see such strong investor support for EBR’s initial public offering,” said John McCutcheon, President and CEO of EBR Systems. “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.”

In October, EBR successfully completed an AU$110M underwritten capital raise, which was strongly supported by new and existing institutional shareholders. Existing Australian institutional investors including include Brandon Capital, M.H. Carnegie & Co, Hostplus, TelstraSuper and HESTA contributed more AU$30M of the funds raised under the offer.

“EBR’s WiSE leadless pacemaker technology is one of the most exciting cardiology technologies in development, and it is fantastic that more Australian investors can now back it,” says Dr. Chris Nave, founding partner of Brandon Capital, manager of the Medical Research Commercialisation Fund (MRCF), Australia’s largest life science investment fund. “EBR’s early clinical data is very promising, and for those heart failure patients not able to receive traditional cardiac resynchronization therapy, it is life changing: the difference between living a normal life, as opposed to being constantly short of breath, often housebound and unable to perform simple daily tasks.”

“EBR’s highly experienced management team come with significant commercialization success in medical devices and cardiology. This listing is great news for Australian heart failure patients and investors alike.”

EBR is initially targeting patients who cannot receive CRT from existing devices, or are at high risk for conventional upgrades, which represents an estimated addressable market of US$2.1B. The WiSE technology platform eventually can be leveraged and extended into other patient groups, expanding EBR’s market opportunity to US$7.1B.

Australia is a global leader in clinical cardiology research programs, and the country has been a pioneer in developing pacemaker technology, making it an integral part of EBR’s global clinical program, and an obvious location for EBR’s listing. The company has already partnered with leading Australian physicians for clinical trials at institutions, including Royal Adelaide, Monash Medical Centre, and Prince of Wales, with the first Australian WiSE patient treated in February 2018.

In a world-first last year, a team of globally renowned cardiologists from Monash Health used EBR’s WiSE system, in combination with an intracardiac pacemaker, to complete the world’s first implantation of a totally leadless heart pacemaker system in a patient who had not previously had a pacemaker implanted. Following the success of the procedure, a clinical study in Australia and Europe is planned for next year to extend the use of the WiSE CRT system, in combination with an intracardiac pacemaker, to achieve totally leadless CRT as the first and preferred option for heart failure patients.

Australian investors have demonstrated a strong appetite for healthcare investment in recent years. Healthcare makes up approximately 10 percent of the Australian equity market of ASX listed companies. The ASX ranks third globally for healthcare listings over the last five years, with 200 percent growth in the market capitalization of the healthcare sector since 2016.i

Biotech giant CSL is one of the three most valuable ASX listed companies. Other highly successful global medical device companies listed on the ASX include Cochlear and ResMed.

The world’s first pacemaker was made in Sydney in 1929 and successfully used to resuscitate a newborn infant in 1929.ii

EBR Systems’ WiSE Technology

EBR Systems’ WiSE™ CRT System is the world’s only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart’s left ventricle. This has long been a goal of cardiac pacing since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location. WiSE technology enables cardiac pacing of the left ventricle with a novel cardiac 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 – are potentially eliminated.

WiSE is an investigational device and is not currently available for sale in the United States.

About EBR Systems

Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. The company’s initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring CRT. Future products will address wireless endocardial stimulation for bradycardia and other non-cardiac indications. EBR Systems is backed by respected private equity investors including M.H. Carnegie & Co., Brandon Capital Partners, Split Rock Partners, Ascension Ventures and Emergent Medical Partners.

i ASX-listed healthcare sector deepens and strengthens ii https://www.heartlungcirc.org/article/S1443-9506(11)01188-7/pdf

Contacts

Cam Hutton, EBR Systems, Inc., info@ebrsystemsinc.com https://ebrsystemsinc.com