- EBR Systems (EBR) completes interim patient enrolment in the pivotal SOLVE-CRT IDE trial of WiSE
- The trial is evaluating the safety and efficacy of the WiSE System in up to 300 patients with acute lead failures, chronic lead failures, high-risk upgrades and leadless upgrades
- WiSE is a wireless, endocardial pacing system for use in stimulating the heart’s left ventricle which is believed to be the more anatomically correct location for pacing equipment
- EBR has also executed a five-year agreement for a US$50 million (A$72.63 million) growth capital facility with venture debt provider, Runway Growth Capital
- Shares in EBR are up 41 per cent and were trading at 53 cents at 1:12 pm
EBR Systems (EBR) has completed interim patient enrolment in the pivotal SOLVE-CRT IDE trial of WiSE.
The SOLVE trial is evaluating the safety and efficacy of the WiSE System in up to 300 patients with acute lead failures, chronic lead failures, high-risk upgrades and leadless upgrades.
The primary endpoints are to achieve more than a 9.3 per cent improvement in heart function and have less than 30 per cent of patients with device or procedure-related complications.
Following the six-month follow up of the last patient, EBR expects to release results in Q1 2023.
The WiSE System is a wireless, endocardial pacing system for use in stimulating the heart’s left ventricle which is believed to be the more anatomically correct location for pacing equipment.
EBR is targeting pre-market approval submission for the US Food and Drug Administration approval in H2 2023.
“We are extremely excited to achieve this significant milestone, the completion of interim enrolment in the pivotal SOLVE trial, which is broadly in line with our timing expectations,” President and CEO John McCutcheon said.
“Each patient is implanted with WiSE and followed up for a period of 6 months. WiSE offers a unique solution to these patients who would otherwise have no other treatment options and face a high risk of hospitalisation and mortality.
“Following previous trials, we remain confident on achieving the key primary endpoints and look forward to sharing our headline results in 1Q 2023 and rapidly move towards commercialisation in key global markets.”
EBR has also executed a five-year agreement for a US$50 million (A$72.63 million) growth capital facility with venture debt provider, Runway Growth Capital.
The money will provide the company with funding flexibility and will be used to support growth and commercialisation activities.
“Given the current macroeconomic conditions globally including rising inflation, increasing interest rates, indicators of a recession, volatility in global equity capital markets falling market indices, this debt facility provides EBR with the additional balance sheet flexibility to protect shareholder value as the company progresses through its clinical and commercial milestones,” Mr McCutcheon added.
“The facility is structured in such a way that the company can choose to draw on future tranches after meeting specific milestones.”
Shares in EBR were up 41 per cent and were trading at 53 cents at 1:12 pm AEST.