CRT: Cardiac Resynchronisation Therapy, RV: Right ventricle 1Excludes IPO
2Breakthrough Device Designation provides greater access to the FDA and initial multi-yearpayment coverage
Investment highlights
onlyUnique novel technology
EBR's WiSE® is the
w rld's smallest inside- the heart leadless (wireless) cardiac
usepacemaker and the only wireless CRT solution.
Over US$200m1 invested in WiSE® to date, with 97 issued patents globally.
nal
Large addressable market
Targeting initial addressable market of ~US$2.1bn.
Initially targeting patients who cannot receive CRT from existing devices or are at high risk for conventional upgrades.
De-risked clinical profile
Currently in final stage of pivotal SOLVE trial.
SOLVE trial design agreed upon with FDA.
Extensive clinical experience with >350 patients treated to date.
Previous studies have exceeded endpoints that have been set for the pivotal trial.
Rapid path to commercialisation
WiSE® has been awarded FDA Breakthrough Device Designation2.
Targeting FDA approval and US commercial launch in H2 2023 with initial adoption from sites participating in clinical trials.
Value upside potential
WiSE® can be extended into other patients, expanding addressable market to ~US$7.1bn.
Increasing adoption of wireless RV pacemakers creates a new market - WiSE® is the only device which can upgrade wireless RV pacemakers to wireless CRT.
2
Traditional pacemakers are suboptimal
Traditional pacemakers use wires to deliver energy to the heart, which can lead to many problems
nal use lyno
Coronary Sinus limits LV lead placement locations
Pathway for pathogens to myocardium
Associated with phrenic nerve stimulation
RIGHT ATRIUM
LEAD
LEFT VENTRICLE (CS) LEAD
RIGHT VENTRICLE LEAD
Can migrate and sometimes fracture
Difficult to place
LV lead must be placed outside the heart to avoid blood clots
3
1Illustrative sizing (not to scale)
EBR has a wireless solution for heart failure patients
WiSE® is the only wireless device that can deliver cardiac resynchronisation therapy (CRT)
only• Many patients with heart failure require a treatment called Cardiac Resynchronisation Therapy (CRT)
• CRT uses cardiac pacing devices to stimulate the left ventricle and coordinate the left and right sides of the heart
• Many patients are unable to receive traditional CRT with usewires because their anatomy or disease condition
prevents it
• WiSE® is the only solution for these patients to stimulate the left side of the heart, and with a right-side pacer, deliver CRT
nal
Wireless Cardiac Rhythm Management Landscape1
CRT
Bradycardia
Defibrillation
(left ventricle)
(right ventricle/atrium)
(right ventricle/atrium)
Medtronic
Boston
Boston Scientific
Emblem®
Micra®
Scientific
EBR Systems
Empower®
WiSE®
Abbott
Medtronic
Aveir®
EV ICD®
4
Advantages of WiSE®
WiSE® addresses the shortcomings of traditional pacemakers
onlyWireless
Eliminates lead complications such as placement difficulty, b ood clots, unintended nerve stimulation, dislodgement, extraction and repositioning.
Endocardial
Delivers pacing directly to the inside of the left ventricle - useconsidered to be more physiologic.
Customised
Tailored therapy - endocardial pacing provides a greater selection of stimulation sites which may lead to better patient outcomes.
nal
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EBR Systems Inc. published this content on 13 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 March 2022 21:33:06 UTC.
EBR Systems, Inc. is engaged in the treatment for patients suffering from cardiac rhythm diseases by providing physiological stimulation through endocardiac pacing. The Company is engaged in developing and commercializing Wireless Stimulation Endocardially (WiSE), an implantable, cardiac pacing device able to provide stimulation to endocardial (inside the heart) heart tissue for the correction of heart rhythm conditions without requiring the use of leads. WiSE offers leadless solutions for LV Pacing, including cardiac resynchronization therapy (CRT) and conduction system pacing (CSP). The Company also offers CRT devices through the CRM subsegment under the brand names, including Visionist X4 CRT-P, Valitude X4 (CRT-P), Momentum CRT-D, Resonate X4 CRT-D, and Vigilant X4 CRT-D, among others. The Company operates various subsidiaries, which include EBR Systems (AUST) Pty. Ltd. and EBR Systems (UK) Limited, which establish clinical trials in Australia and the United Kingdom, respectively.
EBR SYSTEMS, INC. 
