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Current Report · Items 7.01, 9.01 · 8-K

Kestra Medical Technologies, Ltd.

KMTSNASDAQEQUITYCurrent

Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On November 10, 2025, Kestra Medical Technologies, Ltd. (the “Company”) issued a press release (the “Press Release”) titled “Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra’s ASSURE Device,” which announced results from a late-breaking science presentation titled “Primary Results from the Post-Ap…

Filed Nov 10, 2025Accepted Nov 10, 2025, 4:04 PM ESTCIK 1877184Accession 0001193125-25-274183
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Company context

We are a commercial-stage, wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. We have developed and are commercializing our Cardiac Recovery System platform, a comprehensive and advanced system that integrates monitoring, therapeutic treatment, digital health, and patient support services into a single, unified solution. The cornerstone of our Cardiac Recovery System platform is the ASSURE WCD, a next generation wearable cardioverter defibrillator (“WCD”) used to protect patients at an elevated risk of sudden cardiac arrest (“SCA”), a major public health problem that accounts for approximately 50% of all cardiovascular deaths in the U.S. The ASSURE WCD automatically monitors elevated risk patients and, if needed, delivers a defibrillation shock to return the patient’s heart to normal rhythm. The ASSURE WCD was purpose-built to enhance patient comfort and compliance and directly address the key barriers to adoption associated with the only other commercially available WCD. We believe the ASSURE WCD offers significant clinical and functional advantages, including greater patient compliance as a result of a major reduction in false alarms, enhanced comfort and wearability. In addition to the ASSURE WCD, our Cardiac Recovery System platform includes a comprehensive suite of fully integrated digital soluti

Current securities

Recent company filings

  1. 4 filingSep 23, 2026
  2. 144 filingSep 21, 2026
  3. 10-Q filingSep 14, 2026
  4. Results of Operations and Financial ConditionSep 14, 2026
  5. 4 filingSep 10, 2026

Disclosure sections

Items 7.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On November 10, 2025, Kestra Medical Technologies, Ltd. (the “Company”) issued a press release (the “Press Release”) titled “Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra’s ASSURE Device,” which announced results from a late-breaking science presentation titled “Primary Results from the Post-Approval Study of a Next Generation Wearable Cardioverter Defibrillator System (ACE-PAS Trial),” presented at the American Heart Association Scientific Sessions 2025 in New Orleans (the “2025 AHA Sessions”). A copy of the Press Release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. The foregoing information in this Item 7.01 (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference into any registration statement or any other document filed pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. Forward-Looking Statements This Current Report on Form 8-K and the materials furnished herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, the Company’s goals and prospects, the ACE-PAS study, the potential uses and benefits of the evidence collected therefrom and additional analyses that may be shared from the ACE-PAS study in the future. Any statements in this Current Report on Form 8-K and the materials furnished herewith that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. You can also identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. All information in this Current Report on Form 8-K is as of the Date of Report indicated above. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and there is no assurance that any outcome expressed in these forward-looking statements will be realized in whole or in part. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to the Company’s limited operating history and history of net losses; the Company’s ability to successfully achieve substantial market adoption of the Company’s products; competitive pressures; the Company’s ability to adapt the Company’s manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; the Company’s ability to obtain and maintain adequate coverage and reimbursement levels for the Company’s products; the Company’s ability to comply with changing laws and regulatory requirements and resulting costs; the Company’s dependence on a limited number of suppliers; and other risks and uncertainties, including but not limited to those described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended April 30, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) on July 17, 2025, and in other periodic reports filed by the Company with the SEC.
Filed exhibits (1)
EX-99.1 (by filename) ck0001877184-ex99_1.htm

EX-99.1 2 ck0001877184-ex99_1.htm EX-99.1 EX-99.1 Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra’s ASSURE Device KIRKLAND, Wash., November 10, 2025 - Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced primary results from the ASSURE® WCD Clinical Evaluation Post-Approval Study (ACE-PAS), presented as a late-breaking science session at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans. ACE-PAS, the largest prospective real-world study of wearable defibrillators to date, confirmed the strong safety and effectiveness of the ASSURE WCD in clinical practice. “ACE-PAS delivers robust, real-world evidence on how the ASSURE WCD performs in routine care and provides contemporary data describing the risk of life-threatening ventricular tachycardia and fibrillation in diverse populations with reduced cardiac function,” said Jeanne E. Poole, MD, Professor of Medicine at the University of Washington and Principal Investigator. “Life-threatening arrhythmias can occur early in patients with low ejection fraction who have rec…

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