Kestra Medical Technologies today disclosed the primary findings of the ASSURE WCD Clinical Evaluation Post‑Approval Study (ACE‑PAS), the largest prospective real‑world study of wearable cardioverter defibrillators ever conducted. The study enrolled 21,612 patients across the United States and was presented as a late‑breaking science session at the American Heart Association Scientific Sessions 2025 in New Orleans.
The ACE‑PAS results demonstrate that the ASSURE WCD delivers strong safety and effectiveness in routine clinical practice. Inpatient data show an inappropriate‑shock rate of 0.0065 per patient‑month, a median wear time exceeding 23 hours per day, and a false‑alarm rate of 6%, compared with the incumbent LifeVest’s 46% rate. The study also reported a 100% success rate in converting life‑threatening ventricular tachycardia and fibrillation events, underscoring the device’s reliability.
These findings are expected to accelerate payor coverage decisions, expand Kestra’s commercial footprint, and reinforce its position as a leading alternative to the legacy LifeVest. By providing the most comprehensive real‑world evidence to date, the study supports the company’s ongoing efforts to secure reimbursement, broaden market penetration, and drive future revenue growth.
Kestra’s financial performance has been strong in the same period. Fiscal 2025 revenue reached $59.8 million, up 115% from $26.5 million in fiscal 2024, while gross margin expanded to 40.5% from 1.3% the prior year. Despite a net loss of $113.8 million, the company’s IPO in March 2025 raised $205.2 million in net proceeds and it now projects fiscal 2026 revenue of $85 million, a 42% increase from fiscal 2025.
CEO Brian Webster said, “These results reinforce the critical role wearable device monitoring and therapy can play in protecting patients during periods of elevated risk.” He added that the ACE‑PAS data “may help inform future updates to clinical practice—particularly around how physicians identify and protect patients at early risk of sudden cardiac death.”
Analysts have responded positively to the study, with a consensus target price of $27.17 and a mix of buy, hold, and sell ratings. The study’s robust safety profile and high patient compliance are viewed as key drivers that could influence payor coverage and adoption rates, potentially reshaping the competitive landscape dominated by LifeVest.
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