Anteris Technologies Presents Data from 100 DurAVR® THV Patients at PCR London Valves

Rhea-AI Summary

Anteris Technologies (NASDAQ: AVR) presented 30-day pooled outcomes for 100 small‑annulus severe aortic stenosis patients treated with the DurAVR® THV at PCR London Valves (Nov 17, 2025).

Key results: mean pressure gradient 8.2 ± 3.1 mmHg, effective orifice area 2.2 ± 0.3 cm2, 0 valve‑related deaths, 0 moderate/severe paravalvular leak, and 97% freedom from moderate/severe prosthesis‑patient mismatch; technical success was 100% in the last 50 consecutive implants. The analysis pools EMBARK and early feasibility studies and represents ~20% of planned PARADIGM randomized cohort enrollment.

Positive

• EOA 2.2±0.3 cm2 at 30 days
• Mean gradient 8.2±3.1 mmHg at 30 days
• 0 valve‑related deaths at 30 days
• 0 moderate/severe PVL at 30 days
• 97% freedom from moderate/severe PPM
• 100% technical success in last 50 consecutive implants

Negative

• Follow‑up limited to 30 days
• Pooled data from EMBARK and EFS, not randomized
• Represents ~20% of planned PARADIGM enrollment

Insights

Clinical cardiac device expert

Thirty-day pooled data show strong hemodynamics and low prosthesis‑patient mismatch in small annuli patients.

The DurAVR® THV in 100 small annuli patients produced a mean pressure gradient of 8.2 ± 3.1 mmHg and an effective orifice area of 2.2 ± 0.3 cm2, with no moderate or severe paravalvular leak and no valve‑related mortality at 30 days.

These metrics describe a favourable immediate valve performance profile, especially the 97% freedom from moderate or severe prosthesis‑patient mismatch, a key short‑term predictor of valve function in small annuli.

Watch for validated longer‑term clinical endpoints and event rates beyond 30 days; the presented data do not confirm durable benefit over time.

Regulatory and commercialization expert

Early outcomes support a stronger clinical story ahead of the randomized PARADIGM program.

The pooled cohort represents roughly 20% of planned PARADIGM enrollment and links EMBARK/EFS experience to the randomized program, showing 100% technical success in the last 50 consecutive implants.

Regulatory attention will focus on sustained safety and functional endpoints at later timepoints and in randomized comparisons; the PARADIGM Trial will provide those data.

Concrete items to monitor include one‑year durability metrics presented at TCT, randomized PARADIGM interim readouts, and any regulatory filings tied to those outcomes within typical trial timelines.

MINNEAPOLIS and BRISBANE, Australia, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) today released 30-day clinical outcomes for the DurAVR^® THV in one hundred severe aortic stenosis patients with small aortic annuli (aortic annulus area 404 ± 37mm²). The DurAVR^® THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 97% freedom from moderate or severe prosthesis-patient mismatch^* (PPM) in a cohort of small annuli patients similar to the one reported in the SMART Trial¹.

The late-breaking science was presented by Prof. Dr. Ole De Backer at the PCR London Valves conference in London, United Kingdom with simultaneous publication online in EuroIntervention - ‘Thirty-day outcomes of a novel biomimetic balloon-expandable transcatheter heart valve in patients with small aortic annuli’ (DOI: 10.4244/EIJ-D-25-01106).

30-day Results Highlights for 100 DurAVR^® THV Patients

• DurAVR^® THV delivered a favorable hemodynamic profile with a large EOA of 2.2 ± 0.3 cm² and a single digit mean pressure gradient (MPG) of 8.2 ± 3.1 mmHg. 
  
• At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak (PVL).
  
• Prosthesis-patient mismatch was just 3.0% compared with 11.2% to 35.3%¹ for current commercial devices, highlighting a meaningful reduction in a key predictor of valve failure and disease progression.
  
• A technical success rate^** of 100% was achieved in the last 50 consecutive patient implants.
  

“The DurAVR^® THV demonstrated high rates of technical and device success with encouraging 30-day hemodynamic outcomes, including very low PPM in small annuli patients. These results reflect a unique balance of balloon-expandable benefits characterised by high device success and low pacemaker rates, combined with a hemodynamic profile typically associated with self-expanding platforms,” said Prof. Dr De Backer, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

“When PPM occurs, patients essentially exchange one obstruction for another. Moderate to severe PPM is independently associated with reduced survival and increased risk of structural valve deterioration^2,3. Achieving 97% freedom from moderate or severe PPM is clinically relevant, particularly in small annuli patients where the risk of PPM is amplified,” said Chris Meduri, M.D., Anteris Chief Medical Officer.

This pooled analysis of 100 patients derived from the ongoing EMBARK study and early feasibility studies (EFS) conducted in the United States and Europe, consists of patients with small aortic annuli (SAA) treated with the Small size DurAVR^® THV.

“When we look at the strength of the 30-day outcomes together with the 1-year results presented at TCT, we see a consistent clinical profile that serves as a potential proxy for the recently initiated PARADIGM Trial. This pooled analysis of 100 patients represents approximately 20% of the planned DurAVR^® enrolment for the all-comers randomized cohort of PARADIGM. This consistency across earlier and longer-term patient outcomes reinforces our confidence in DurAVR^®’s potential as we advance this life-saving technology toward anticipated commercialization,” said Vice Chairman and CEO, Wayne Paterson.

The global PARADIGM Trial (ClinicalTrials.gov ID NCT07194265) is a prospective, randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR^® THV compared to commercially available transcatheter aortic valve replacements (TAVRs) in the treatment of severe aortic stenosis.

^{*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).}

^{**As defined in VARC-3.}

^{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.}

^{3. Hahn RT, Pibarot P. Prosthesis-patient mismatch in transcatheter and surgical aortic valve replacement. Ann Cardiothorac Surg. 2024 May 31;13(3):211-223. doi: 10.21037/acs-2023-aae-0166. Epub 2024 Apr 28. PMID: 38841078; PMCID: PMC11148757.}

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 collaboration 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, including the objectives of, plans for and size of Anteris’ studies and trials. 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 Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.

For more information:

Investor Relations	Investor Relations (US)
investors@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
X	@AnterisTech
LinkedIn	https://www.linkedin.com/company/anteristech

FAQ

What were the 30-day hemodynamic results for Anteris DurAVR (AVR) reported Nov 17, 2025?

DurAVR showed a mean pressure gradient of 8.2 ± 3.1 mmHg and EOA of 2.2 ± 0.3 cm2 at 30 days.

How common was prosthesis‑patient mismatch in the 100 DurAVR patients (AVR)?

The cohort demonstrated 97% freedom from moderate or severe prosthesis‑patient mismatch.

Were there any valve‑related deaths or moderate/severe PVL reported for DurAVR (AVR)?

At 30 days there were no valve‑related deaths and no moderate or severe paravalvular leaks.

How material is this 100‑patient data set to the PARADIGM trial for DurAVR (AVR)?

The 100‑patient pooled analysis represents approximately 20% of planned PARADIGM randomized cohort enrollment.

What procedural success was reported for DurAVR implants in the Nov 17, 2025 presentation?

A technical success rate of 100% was reported for the last 50 consecutive implants.

Does the Nov 17, 2025 data for DurAVR (AVR) come from randomized trial results?

No; the reported 100‑patient results are pooled from ongoing EMBARK and early feasibility studies, not from a completed randomized comparison.