Nov 23, 2021

Intellasia East Asia News 23-Nov-2021 Intellasia | PR Newswire Asia | 10:31 AM EBR Systems' WiSE technology is world's first and only wireless, inside the left ventricle of the heart, pacing system for heart failure EBR's planned $110m ASX initial public offering on 24th November 2021, strongly supported by new and existing institutional shareholders Capital to enable completion of pivotal study, targeting FDA submission for approval in 2023 followed by rapid commercial US launch Estimated addressable market of ~US$2.1b, growing to a market opportunity to ~US$7.1bn when extended to other patient groups Strong competitive protection with 53 issued US patents and 44 issued patents outside the US WiSE awarded FDA Breakthrough Device Designation which provides greater interactive and timely communication with the FDA during the review process and initial multi-year payment coverage Highly credentialed management team with a track record in commercialising medical technology companies EBR Chair, Allan Will, oversaw acquisition of Ardian by Medtronic for over US$800m Existing investors, including, Brandon Capital, M.H. Carnegie & Co, Hostplus, TelstraSuper and HESTA contributed more A$30m of the funds raised under the offer Bell Potter, Morgans and Wilsons were joint lead managers to the transaction MELBOURNE, Australia, Nov. 23, 2021 /PRNewswire/ -- Australian investors' strong appetite for healthcare stock continues with the planned AU$110m listing of cardiovascular medical device company, EBR Systems, at 11am Wednesday 24th November on the Australian Securities Exchange (ASX). Silicon Valley-based EBR Systems is pioneering leadless pace making technology. Their WiSE 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 with the equity to complete their pivotal study, targeting US Food & Drug Administration (FDA) submission for approval in 2023, followed by rapid commercial launch in the US, Australia and other key markets. Many patients with heart failure require cardiac resynchronisation 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 are 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," says 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, with its many clinical advantages, so that it can improve the lives of heart failure patients in Australia and around the world." In October, EBR successfully completed a A$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 A$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 resynchronisation 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 commercialisation 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$2.1bn. The WiSE technology platform eventually can be leveraged and extended into other patient groups, expanding EBR's market opportunity to US$7.1bn. Australia is a global leader in clinical cardiology research programmes, and the country has been a pioneer in developing pacemaker technology, making it an integral part of EBR's global clinical programme, and an obvious location for EBR's listing. The company has already partnered with leading AU Physicians for clinical trials at institutions including Royal Adelaide, Monash Medical Centre, and Prince of Wales, with the first AU WiSE patient treated in February 2018. In a world's 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 capitalisation 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 technology and market opportunity EBR Systems' WiSE technology is the world's first and only wireless inside-the-heart pacing system for heart failure. It enables cardiac pacing via a novel, ultrasonically-activated cardiac implant, roughly the size of a large grain of rice, being placed inside the left ventricle. Wireless pacing 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. The need for a pacing wire on the outside of the heart's left ventricle, and the attendant problems, is eliminated. Many patients with heart failure require a treatment called cardiac resynchronisation therapy (CRT), which uses cardiac pacing devices to coordinate the beating of the left and right sides of the heart. WiSE provides a treatment option for patients who are unable to receive cardiac CRT from a traditional lead-based system or are at high risk from an upgrade procedure. Without effective CRT, these patients suffer poor clinical prognosis, poor quality of life and reduced life expectancy. EBR is currently enrolling the final arm of their pivotal study and is targeting FDA approval and US commercial launch in H2 2023 with initial adoption from sites participating in the clinical trial for currently untreatable patients. Established relationships and infrastructure is expected to drive rapid commercialisation in the US and other countries outside of the US following FDA approval. The WiSE system is CE Mark-approved for use in Europe. It is investigational in the US and Australia. Ends EBR Systems' WiSE Technology EBR Systems' WiSE 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.