8-K
Anteris Technologies Global Corp. (AVR)
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): March 31, 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<br><br> <br>9 Sherwood Road<br><br> <br>Toowong,<br> QLD<br><br> <br>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) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br><br> <br>Symbol(s) | Name of each exchange<br><br> <br>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 March 31, 2025, Anteris Technologies Global Corp. (the “Company”) lodged an announcement with the Australian Securities Exchange regarding the Company reaching a clinical milestone of 100 patients treated with DurAVR^®^ Transcatheter Heart Valve (“THV”). A copy of the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained 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 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<br><br> <br>No. | Description |
|---|---|
| 99.1 | ASX Announcement: Anteris Technologies Reaches Clinical Milestone: 100 patients treated with DurAVR^®^THV |
| 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: March 31, 2025 | ||
| By: | /s/ Wayne Paterson | |
| Name: | Wayne Paterson | |
| Title: | Vice Chairman and Chief Executive Officer |
Exhibit 99.1
Anteris Technologies Reaches Clinical Milestone: 100 patients treated with DurAVR^®^THV
MINNEAPOLIS, United States and BRISBANE, Australia 31 March 2025: Anteris Technologies Global Corp. (Anteris^®^ or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices, announces a significant milestone in our mission to restore heart valve patients to healthy function. Our first in class, biomimetic DurAVR^®^ Transcatheter Heart Valve (THV) has now been used to treat over 100 patients worldwide, marking a major achievement in our goal to revolutionize cardiac care in patients affected by severe aortic stenosis.
Highlights:
| • | Over 100 patients successfully treated with the DurAVR^®^ THV, including de novo (first time) aortic stenosis cases, valve-in-valve (ViV) patients and complex anatomies such as bicuspid<br> aortic valve patients* |
|---|---|
| • | 65 patients have successfully completed the primary endpoint measures of safety and efficacy, including hemodynamic benefit at 30-days post implant |
| --- | --- |
| • | One-year efficacy data on 37 aortic stenosis patients continues to validate the exceptional hemodynamic performance, with sustained large effective orifice areas (EOAs) and low mean pressure<br> gradients (MPGs) |
| --- | --- |
| • | Excellent safety profile demonstrated at one-year, with no valve or cardiovascular related mortality |
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| • | Range of valve sizes used to accommodate a broad patient population |
| --- | --- |
Anteris Chief Medical Officer, Chris Meduri, M.D., commented: “We are incredibly proud to have reached this milestone, which represents years of dedication, research, and importantly collaboration with expert physicians in the field. The excellent hemodynamic performance we are seeing is noteworthy in that it shows that DurAVR^®^has the potential to restore natural heart valve function and thereby redefine what success looks like in the treatment of aortic stenosis.”
Dr. Michael Reardon, Allison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital and Study Chair of the DurAVR^®^THV Pivotal Trial said, “We are building on a strong foundation of clinical evidence, and we remain committed to rigorous scientific evaluation as we progress toward the all-risk, head-to-head, DurAVR^®^registration
trial.”
Vice Chairman and CEO, Wayne Paterson added, “This is a clinical milestone for the company and its investors. Not only have we crossed the threshold of having treated over 100 patients, but we have achieved results that are clinically relevant and significantly differentiated to current therapies. DurAVR^®^ is the first new class of product in this space in many years and the current results across often complex patients confirms the value of the product for physicians and patients as we move into our registration trial this year.”
The Company remains on track to commence the DurAVR^®^THV Pivotal Trial in the third quarter of 2025, pending U.S. Food and Drug Administration ("FDA") approval.
*A bicuspid aortic valve (BAV) is a congenital heart condition where the aortic valve, which regulates blood flow from the heart to the aorta, has only two leaflets (or flaps) instead of the normal three.
| 860 Blue Gentian Road,<br><br> <br>Suite 340<br><br> Eagan, MN, 55121<br><br> <br>United States<br><br> <br>T: +1 651 493 0606<br><br> <br>info.us@anteristech.com | Anteris Technologies Global Corp.<br><br> <br>BRISBANE | MINNEAPOLIS | GENEVA | MALAGA<br><br> <br> <br><br> <br><br><br> <br>anteristech.com |
Toowong Tower, Level 3, Suite 302<br><br> <br>9 Sherwood Road, Toowong<br><br> QLD 4066, Australia<br><br> <br>T: +61 1300 550 310<br><br> <br>info.au@anteristech.com<br><br> <br>ARBN: 677 960 235 |
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ENDS
About Anteris
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.
Anteris’ lead product, the DurAVR^®^ Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR^®^ THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR^®^THV is made using a single piece of molded ADAPT^®^ tissue, Anteris’ patented anti-calcification tissue technology. ADAPT^®^ tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR^®^ THV System is comprised of the DurAVR^®^ valve, the ADAPT^®^ tissue, and the balloon-expandable ComASUR^®^ Delivery System.
Forward-Looking Statements
This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “intend,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.
Authorisation and Additional information
This announcement was authorised for release on the ASX by the Board of Directors.
For more information:
| Investor Relations | Investor Relations (US) | |
|---|---|---|
| investor@anteristech.com | mchatterjee@bplifescience.com | |
| Debbie Ormsby | Malini Chatterjee, Ph.D. | |
| Anteris Technologies Global Corp. | Blueprint Life Science Group | |
| +61 1300 550 310 | +61 7 3152 3200 | +1 917 330 4269 |
| Website | www.anteristech.com | |
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| X | @AnterisTech | |
| https://www.linkedin.com/company/anteristech | ||
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