The FDA has permitted WiSE's use for cardiac resynchronisation therapy (CRT) in adults. Specifically it will be used for: (a) patients with a left-heart CRT with failing leads (b) high risk patients with a right-heart CRT but need a biventricular system (right and left sides of the heart) and are not strong enough for a lead system and (c) patients where implantation of a left-heart lead system has not been achievable.
Leadless Ultrasound Innovation
The WiSE electrode itself is the size of a rice grain, and the overall system has three main components. The rechargeable battery is inserted under the skin of the chest, connected to a nearby transmitter through a wire. This transmitter leadlessly sends energy ultrasonically to the electrode. Ultrasound has no electromagnetic interference issues. Finally, the electrode proper is endocardial, and converts the ultrasound into energy. EBR's battery is externally rechargeable using a patch, and most patients will need to recharge weekly.
EBR Scores Major US Reimbursement Programs
WiSE CRT's commercial launch will be supported by inclusion in three of the CMS' (the parent to Medicare) most significant reimbursement schemes:
1. Transitional Coverage for Emerging Technologies (TCET): Highly-selective program aimed to expedite coverage. Inclusion was announced on Monday, and discussion is underway.
2. New Technology Add-On Payment (NTAP): Offers hospitals two to three years of in-patient reimbursement from 1 October to encourage adoption irrespective of WiSE's budget impact.
3. Transitional Pass-Through (TPT): Outpatient coverage while CMS adjusts base payments, still under discussion.
Owing to its performance in the pivotal SOLVE-CRT trial, WiSE gained FDA Breakthrough Device Designation. In the 183-participant study of higher-risk patients, WiSE CRT showed a 16.4% decrease in left-ventricle end-systolic volume, indicating greater cardiac efficiency. Regarding safety, 80.9% of patients remained free from complications, substantially better than existing CRT systems.
A Premium Solution
EBR has positioned WiSE CRT as a complementary solution in the broader US$13.5 billion global cardiac rhythm management. It specifically targets a US$3.6 billion slice across leadless upgrades,
acute and chronic lead failures, and high-risk upgrades. WiSE is the only wireless system offering endocardial left-ventricle pacing.
On approval, EBR's shares fell by 17.2% to A$1.40, with some profit taking likely. EBR is capitalised at A$522 million with $106 million in cash at the end of last year.
Bioshares recommendation: Speculative Buy Class A
