AVR announces PARADIGM global pivotal trial first patients treated

Rhea-AI Filing Summary

Anteris Technologies Global Corp. (AVR) furnished an update via Form 8-K stating that the first patients have been enrolled and successfully treated in the DurAVR Transcatheter Heart Valve global pivotal PARADIGM trial for severe calcific aortic stenosis.

The company noted this information is being furnished, not filed, under the Exchange Act. An accompanying press release dated October 27, 2025 was included as Exhibit 99.1.

Insights

Medtech clinical/regulatory analyst

First patients treated marks the start of a pivotal THV study.

Anteris reports initial patient treatment in the global pivotal PARADIGM trial evaluating its DurAVR transcatheter heart valve for severe calcific aortic stenosis. In medical devices, a pivotal trial generally supports potential regulatory submissions, but outcomes depend on safety and effectiveness data gathered over the study.

The disclosure is furnished, not filed, and provides no efficacy metrics or timelines. Subsequent filings may provide enrollment progress, endpoints, or regulatory interactions tied to the PARADIGM trial.

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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): October 27, 2025

Anteris Technologies Global Corp.

(Exact name of registrant as specified in its charter)

Delaware	001-42437	99-1407174
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

Toowong Tower, Level 3, Suite 302 9 Sherwood Road Toowong, QLD Australia		4066
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: +61 7 3152 3200

Not Applicable

(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, par value $0.0001 per share		AVR		The Nasdaq Global 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 October 27, 2025, Anteris Technologies Global Corp. (the “Company”) issued a press release announcing that the first patients have been enrolled and successfully treated in the DurAVR^® Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”).

The information in this Current Report on Form 8-K, including the exhibit attached hereto, is being furnished and shall not be deemed to be filed for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or incorporated by reference into any filing under the Securities Act of 1933 (the “Securities Act”) or the Exchange Act, unless such subsequent filing specifically references this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The following exhibits are filed with this Current Report on Form 8-K:

Exhibit No.		Description
99.1		Press release dated October 27, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

	Anteris Technologies Global Corp.
Date: October 27, 2025
	By:	/s/ Wayne Paterson
	Name:	Wayne Paterson
	Title:	Chief Executive Officer

FAQ

What did Anteris Technologies (AVR) announce in its 8-K?

The company reported that the first patients were enrolled and successfully treated in the DurAVR Transcatheter Heart Valve global pivotal PARADIGM trial.

What is the PARADIGM trial noted by AVR?

It is the global pivotal trial evaluating the DurAVR transcatheter heart valve in patients with severe calcific aortic stenosis.

When was the press release issued by Anteris (AVR)?

A press release dated October 27, 2025 was included as Exhibit 99.1.

Is the information considered filed or furnished?

The company stated the information is being furnished and not deemed filed under the Exchange Act.

What exchange and ticker symbol does Anteris use?

Anteris Technologies Global Corp. trades on The Nasdaq Global Market under the symbol AVR.

Which exhibit accompanies this update?

Exhibit 99.1, the press release dated October 27, 2025, and Exhibit 104, the cover page Inline XBRL file.