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목요일 Sep 11 2025 21:10
6 분
Kestra Medical Technologies (KMTS 1.04%), a developer of wearable cardiac defibrillators and digital cardiac care solutions, released its results for Q1 FY2026 on September 11, 2025. The headline news was a 52% year-over-year increase in revenue, alongside a raised annual revenue outlook to $88 million for FY2026. The quarter showed strong demand but also highlighted ongoing pressure from rising expenses and widening losses.
| Metric | Q1 FY26 (Three Months Ended July 31, 2025) | Q1 FY25 (Three Months Ended July 31, 2024) | Y/Y Change |
|---|---|---|---|
| Revenue | $19.4 million | $12.8 million | 52.0 % |
| Gross Margin | 45.7 % | 32.9 % | 12.8 pp |
| Adjusted EBITDA | ($19.4 million) | ($15.7 million) | (23.6 %) |
| Net Loss per Share, Diluted | ($0.50) | ($1.12) | N/A |
| Cash and Cash Equivalents | $201.2 million | — | N/A |
Kestra Medical Technologies focuses on wearable cardioverter defibrillators (WCDs), specifically the ASSURE system, which helps protect cardiac patients from sudden cardiac arrest. The ASSURE system is a wearable medical device that monitors for abnormal heart rhythms and can deliver life-saving therapy automatically when needed.
The company’s strategy centers on five key areas: expanding its U.S. and international presence, innovating with advanced cardiac monitoring and digital health, solidifying regulatory and payor coverage, delivering scalable operations, and strengthening its revenue cycle management. Kestra’s success is tied to the adoption of the ASSURE system, payer contract coverage, and its ability to increase the efficiency of commercial operations while maintaining close relationships with healthcare providers.
ASSURE, Kestra’s wearable cardioverter defibrillator, is the core of its product platform. This system features high-resolution electrocardiogram (ECG) monitoring and an adaptive intelligence engine to minimize false alarms, making it more comfortable and accurate for patients. ASSURE’s false alarm rate is 6%, compared to 46% for the competing device, based on company estimates from the July 2024 ACE-PAS FDA submission.
Kestra continues to maintain its FDA-approved status in the U.S, and is expanding its commercial footprint. Management again highlighted improvements in payer integration and revenue cycle management, noting beneficial impacts from a higher in-network patient mix and more effective billing processes. Coverage now includes insurance contracts accounting for over 285 million U.S. lives, representing nearly 90% of the addressable U.S. patient population as of April 30, 2025.
The company, however, faces rising costs as it scales. Increased commercial and administrative expenses reflect Kestra’s efforts to reach additional physicians, hospitals, and payers, as well as to support patients wearing the ASSURE system. With investments focused on expanding market share and supporting a growing base of prescriptions, cost efficiency and disciplined growth remain areas for investors to monitor closely.
Kestra did not disclose any new international regulatory progress or updates regarding its plans for a CE Mark in Europe during the quarter. The company’s business model remains heavily U.S.-focused for now, though long-term growth initiatives still envision global market expansion.
Kestra raised its full-year FY2026 revenue guidance to $88 million, up from $85 million, representing a 47% increase over the previous fiscal year’s revenue. No specific guidance was provided for profitability, margin, or cash flow for the coming quarters.
Management communicated a continued focus on expanding its commercial presence, improving gross margin, and further strengthening payer and reimbursement channels. Investors should keep an eye on the path to achieving operating leverage, trends in prescription growth, shifts in payer mix, developments on international expansion, and the company’s efforts to rein in cost escalation while supporting high top-line growth.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
Wearable cardioverter defibrillators like the ASSURE system represent a significant advancement in cardiac care. They provide continuous monitoring and immediate intervention for patients at risk of sudden cardiac arrest, offering a crucial safety net outside of a hospital setting. The accuracy and reliability of these devices are paramount, as is patient comfort and compliance. Factors such as false alarm rates, battery life, and ease of use directly impact patient adherence and the effectiveness of the therapy.
The market for wearable defibrillators is driven by several factors, including an aging population, increasing prevalence of heart conditions, and advancements in wearable technology. However, challenges remain in terms of cost, reimbursement policies, and competition from other cardiac therapies. Companies in this space must demonstrate the clinical and economic value of their devices to gain widespread adoption and secure favorable reimbursement rates.
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