8-K - MMSI - Equibles

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

Date of Report (date of earliest event reported): November 13, 2025

Merit Medical Systems, Inc.

(Exact name of registrant as specified in its charter)


Utah	0-18592	87-0447695
(State or other jurisdiction of	(Commission	(I.R.S. Employer
incorporation or organization)	File Number)	Identification No.)


1600 West Merit Parkway
South Jordan , Utah		84095
(Address of principal executive offices)		(Zip Code)

( 801 ) 253-1600

(Registrant's telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, no par value		MMSI		NASDAQ Global Select Market

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 13, 2025, Merit Medical Systems, Inc. (“Merit”) issued a press release announcing certain updates with respect to its WRAPSODY® Cell-Impermeable Endoprosthesis product. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.

The information contained in Item 7.01 of this Current Report on Form 8-K (including the exhibits attached hereto) is furnished pursuant to General Instruction B.2 of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing made by Merit under the Securities Act of 1933, as amended, or the Exchange Act.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits


EXHIBIT NUMBER	****	DESCRIPTION

99.1		Press Release, dated November 13, 2025, entitled “Merit Medical Provides Update on U.S. Reimbursement and Commercial Strategies for WRAPSODY® Cell-Impermeable Endoprosthesis”.
104		The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


	MERIT MEDICAL SYSTEMS, INC.


Date: November 13, 2025	By:	/s/ Brian G. Lloyd
		Brian G. Lloyd
		Chief Legal Officer and Corporate Secretary

EXHIBIT 99.1

Merit Medical Provides Update on U.S. Reimbursement and Commercial Strategies for WRAPSODY® Cell-Impermeable Endoprosthesis*.*

SOUTH JORDAN, Utah, November 13, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today that the U.S. Centers for Medicare & Medicaid Services (“CMS”) has notified Merit that its application for Transitional Pass-Through (“TPT”) incremental payment for WRAPSODY® Cell-Impermeable Endoprosthesis (“CIE”) procedures in the outpatient and ambulatory surgery center (“ASC”) settings requires further consideration prior to CMS making a final decision. CMS notified Merit that it has deferred Merit’s application for the WRAPSODY® CIE to the Calendar Year 2027 Outpatient Prospective Payment System rule, making January 1, 2027, the earliest possible effective date.

“While we are disappointed with the deferral of our application for TPT incremental payment, we believe this presents an opportunity for an important strategic pivot,” said Martha G. Aronson, Merit’s President and CEO. “Our efforts to secure incremental payment in the outpatient and ASC settings have impacted the pace of U.S. commercialization of our innovative solution for physicians treating hemodialysis patients suffering from venous outflow obstructions. We are enacting a new commercial strategy that increases patient access and optimizes adoption and utilization of our clinically superior technology. We expect this strategy to improve patient outcomes, reduce the cost of treating this large and growing patient population, and generate strong, margin-accretive revenue growth for Merit in the years to come. We have elected to withdraw our application for TPT incremental payment and intend to begin our full commercialization of the WRAPSODY CIE in the U.S. immediately.”

Ms. Aronson continued, “The WRAPSODY CIE was developed to help physicians restore vascular access for patients. The clinical evidence supporting this device is remarkable, particularly the recently announced 24-month efficacy results from both the randomized arteriovenous fistula arm and single-arm arteriovenous graft cohort of our WRAPSODY WAVE Trial. This impressive clinical data represents not only an invaluable tool in our discussions with physicians, hospital administrators, and payers, but also is a key differentiator versus existing competitors. Armed with the best technology, the strongest clinical evidence, and a focused and engaged commercial team, we believe we are well positioned to penetrate the U.S. dialysis access maintenance market opportunity in the coming years.”

For the full year 2025 period, Merit continues to forecast U.S. revenue from the sales of the WRAPSODY CIE in the range of $2 million to $4 million.

On December 19, 2024, the WRAPSODY CIE received premarket approval from the U.S. Food and Drug Administration (FDA). On April 30, 2025, the device was approved by Health Canada. The WRAPSODY CIE previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.

For more information on the WRAPSODY CIE within the United States, please visit: https://www.merit.com/product/WRAPSODY-cie/. For information on the device outside of the United States, please visit: https://www.merit.com/product/merit-WRAPSODY/.

In the United States and Canada, real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which is designed to enroll up to 250 patients. For additional information on Merit’s WRAP North America Registry, please visit: https://clinicaltrials.gov/study/NCT06807099.

Outside of North America, real-world outcomes of the WRAPSODY CIE are being evaluated in the WRAP Global Registry.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit's filings with the U. S. Securities and Exchange Commission (“SEC”). For discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC, which Merit updated in Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025, June 30, 2025 and September 30, 2025, which Merit filed with the SEC. Actual results will likely differ, and may differ materially, from anticipated results.

ABOUT MERIT

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,400 people worldwide.

TRADEMARKS

Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.

CONTACTS

PR/Media Inquiries Sarah Comstock

Merit Medical +1-801-432-2864 | sarah.comstock@merit.com

Investor Inquiries Mike Piccinino, CFA, IRC

ICR Healthcare +1-443-213-0509 | mike.piccinino@westwicke.com