KMTS 8-K
Kestra Medical Technologies, Ltd. (KMTS)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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.
Item 9.01 Financial Statements and Exhibits.
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File, formatted in Inline XBRL. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Kestra Medical Technologies, Ltd. |
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Date: |
November 10, 2025 |
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/s/ Brian Webster |
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Name: Title: |
Brian Webster |
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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 recently experienced a myocardial infarction, undergone coronary revascularization, or have been newly diagnosed with heart failure. These patients may have significant recovery of heart function during a waiting period of one to six months, such that a permanently implanted defibrillator is not indicated. The ASSURE WCD should be considered to protect patients at elevated risk of sudden cardiac death during this vulnerable time.”
The study enrolled 21,612 patients across the United States. Key findings demonstrate consistent safety, effectiveness, and compliance in real-world use:
“These results reinforce the critical role wearable device monitoring and therapy can play in protecting patients during periods of elevated risk,” said Brian Webster, President and Chief Executive Officer of Kestra Medical Technologies. “As the largest and most contemporary study of its kind, ACE-PAS provides compelling evidence that may help inform future updates to clinical practice—particularly around how physicians identify and protect patients at early risk of sudden cardiac death. By pairing proven
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performance with connected, data-driven insight, Kestra is redefining what’s possible in wearable protection and advancing evidence-based innovation.”
The ACE-PAS results represent a significant step forward in understanding and managing sudden cardiac arrest risk. Additional analyses from the study will be shared in forthcoming scientific forums.
A recorded panel discussion featuring ACE-PAS investigators and other leading clinical experts, hosted by MedAxiom, offers further perspective on the study’s design, outcomes, and implications for patient care. The full discussion can be viewed here: https://na2.hubs.ly/H01ZZM90
About ACE-PAS
The ASSURE WCD Clinical Evaluation Post-Approval Study (ACE-PAS) is a prospective, multicenter registry evaluating the use, safety, and effectiveness of the ASSURE Wearable Cardioverter Defibrillator in the prevention of sudden cardiac death. The study enrolled 21,612 patients from November 2021 through July 2025 across the U.S. Primary endpoints were overall VT/VF shock conversion and inappropriate-shock rate.
About Kestra
Kestra Medical Technologies, Ltd. is 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. For more information, please visit www.kestramedical.com.
Forward-Looking Statements
Except where otherwise noted, the information contained in this press release is as of November 10, 2025. Statements in this press release that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains 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. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can 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. 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 our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including 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. These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/.
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