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 21, 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, 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 |
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On March 21, 2025, Anteris Technologies Global Corp. (the “Company”) lodged an announcement with the Australian Securities Exchange regarding the Company’s one-year patient outcomes for 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. |
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The following exhibits are filed with this Current Report on Form 8-K:
| Exhibit<br><br> <br>No. | Description |
|---|---|
| 99.1 | ASX Announcement Regarding one-year patient outcomes for 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 21, 2025 | ||
| By: | /s/ Wayne Paterson | |
| Name: | Wayne Paterson | |
| Title: | Vice Chairman and Chief Executive Officer |
Exhibit 99.1
Anteris Reports One-Year Patient Outcomes for DurAVR^®^ THV
New class, biomimetic TAVR demonstrates sustained hemodynamic performance to one-year
MINNEAPOLIS, United States and BRISBANE, Australia 21 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 to restore healthy heart function, today announced one-year results for patients treated with its proprietary, balloon expandable, DurAVR^®^ Transcatheter Heart Valve (THV) System. Rishi Puri, M.D. PhD will present the data at a late breaking clinical trial session at Sydney Valves on Friday 21 March 2025, 10:30am (AEST), titled: “Pioneering a New Class of Biomimetic TAVR with Sustained 1-Year Performance.”
One-year Results Highlights:
| - | DurAVR^®^ THV demonstrated a favorable hemodynamic profile sustained to one-year, with an Effective Orifice Area (EOA) of 2.1 + 0.2 cm^2^, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler<br> Velocity Index (DVI) of 0.58. |
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| - | At one-year, clinical safety outcomes show positive results with no valve or cardiovascular related mortality and importantly no prosthesis-patient mismatch (PPM*) reported in these<br> small annuli patients (aortic annulus area 395.80 + 37.26mm^2^).<br><br> <br>Current commercial devices have demonstrated rates between 11.2% to 35.3% PPM^1^, a predictor of valve failure and disease progression. |
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Anteris Chief Medical Officer, Chris Meduri, M.D., commented: “The one-year data for DurAVR^®^ THV continues to validate its groundbreaking hemodynamic performance, demonstrating sustained excellent effective orifice area (EOA) and low mean gradients. Most notably, this is the only transcatheter valve to show zero prosthesis-patient mismatch (PPM) in small annuli patients—an achievement that sets a new standard in TAVR. PPM is a well-established predictor of valve failure and disease progression, and eliminating it has profound implications for long-term patient outcomes. These results reinforce the transformative potential of DurAVR^®^ as we move toward pivotal trials.”
Sixty-five (65) patients have completed the primary endpoint measure at 30 days (previously reported as rolling cohorts at multiple medical conferences through 2023-2024). The DurAVR^®^THV System continues to demonstrate a consistent safety and efficacy profile, with high implant success across the clinical program.
The one-year data builds on the existing body of clinical evidence and will be included in the planned Investigational Device Exemption (IDE) submission to the U.S. FDA to seek approval to conduct the DurAVR^®^ THV randomized, global pivotal study.
*Prosthesis‐patient mismatch (PPM) happens when a prosthetic valve, after being implanted, doesn’t have a large enough opening (EOA) to accommodate the patient’s blood flow needs, based on their body size. The result is higher than expected gradients. PPM affects a significant proportion of transcatheter aortic valve (TAVR) patients, particularly patients with a small aortic annulus and has been associated with impaired long-term survival following surgical aortic valve replacement (SAVR)^2^.
^1.^Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchétché D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7. PMID: 38587261.
^2^ Ferrara J, Theron A, Porto A, Morera P, Luporsi P, Jaussaud N, Gariboldi V, Collart F, Cuisset T, Deharo P. Prosthesis-Patient Mismatch in Small Aortic Annuli: Self-Expandable vs. Balloon-Expandable Transcatheter Aortic Valve Replacement. J Clin Med. 2022 Apr 1;11(7):1959. doi: 10.3390/jcm11071959. PMID: 35407567; PMCID: PMC8999619.
ENDS
| 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>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> ARBN: 677 960 235 |
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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, including the time for the presentation of the one-year data results and the inclusion of the one-year data in the IDE submission. 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,” “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 | |
| www.facebook.com/anteristech | ||
| https://www.linkedin.com/company/anteristech | ||
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