Anteris DurAVR® THV Demonstrates Favorable Hemodynamics in Small Annuli Patients with no Valve Related Mortality at One Year

Rhea-AI Summary

Anteris (NASDAQ: AVR) reported one-year pooled outcomes for the DurAVR® Transcatheter Heart Valve (THV) in patients with small aortic annuli (mean annulus area 396 ± 37 mm2).

Key results: EOA 2.1 ± 0.2 cm2, mean pressure gradient 8.6 ± 2.6 mmHg, no valve-related mortality and no moderate or severe paravalvular leak at one year; 30-day prosthesis-patient mismatch was 1.5% versus 11.2%–35.3% for current devices. The pooled cohort included 65 small-annulus patients from EMBARK and a US early feasibility study; >100 patients have been implanted overall. Results will be evaluated further in the randomized PARADIGM pivotal trial (NCT07194265).

Positive

• EOA 2.1 cm2 at one year
• Mean gradient 8.6 mmHg sustained to one year
• No valve-related mortality at one year
• No moderate/severe PVL at one year
• PPM 1.5% at 30 days versus 11.2%–35.3% for comparators

Negative

• Pooled small-annulus cohort size of 65 patients limits generalizability
• Findings are interim from ongoing studies and require confirmation in the PARADIGM RCT

News Market Reaction

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On the day this news was published, AVR declined 7.84%, reflecting a notable negative market reaction. Argus tracked a trough of -24.8% from its starting point during tracking. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $16M from the company's valuation, bringing the market cap to $189M at that time. Trading volume was exceptionally heavy at 8.2x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

MINNEAPOLIS and BRISBANE, Australia, Oct. 28, 2025 (GLOBE NEWSWIRE) -- 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, announced one-year clinical outcomes for the DurAVR^® Transcatheter Heart Valve (THV) in symptomatic severe aortic stenosis patients with small aortic annuli (aortic annulus area 396 + 37 mm²). The DurAVR^® THV System demonstrated single digit mean gradients and large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality at one year, with low prosthesis-patient mismatch at 30 days.

One-year Results Highlights

• DurAVR^® THV delivered a favorable hemodynamic profile sustained to one-year, with an EOA of 2.1 + 0.2 cm² and a mean pressure gradient (MPG) of 8.6 + 2.6 mmHg. 
  
• At one-year, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak (PVL).
  
• At 30-days, prosthesis-patient mismatch* was just 1.5%, 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.

“With small annuli patients, even minor hemodynamic inefficiencies can limit long-term outcomes, which is why optimising physiologic flow is so critical. The latest results we are seeing with the balloon-expandable DurAVR^® valve are impressive, showing restoration of laminar flow, favorable hemodynamics sustained to one year, predictable deployment and a high level of procedural success across a variety of anatomies, which is exactly what we need for this patient population,” commented Dr. Rishi Puri, MD, PhD, Coronary and Structural Interventional Cardiologist at the Cleveland Clinic.

The pooled cohort included 65 patients with small aortic annuli implanted with the DurAVR^® THV from the ongoing EMBARK Study and US Early Feasibility Study (EFS).

The encouraging clinical outcomes observed to date in over 100 patients implanted with the DurAVR^® THV will be further validated in the Company’s recently initiated global pivotal trial (the “PARADIGM Trial”). The 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)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.}

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 statements regarding the further validation of results in the PARADIGM Trial. 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, 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@anteristech.com Debbie Ormsby Anteris Technologies Global Corp. +61 1300 550 310 | +61 7 3152 3200		Investor Relations (US) mchatterjee@bplifescience.com Malini Chatterjee, Ph.D. Blueprint Life Science Group +1 917 330 4269
Website	www.anteristech.com
X	@AnterisTech
LinkedIn	https://www.linkedin.com/company/anteristech

FAQ

What were the one-year hemodynamic results for Anteris DurAVR (AVR) in small annuli?

DurAVR showed EOA 2.1 ± 0.2 cm2 and mean gradient 8.6 ± 2.6 mmHg at one year.

Did Anteris report any valve-related deaths for DurAVR at one year (AVR)?

No; the company reported no valve-related mortality at one year in the pooled cohort.

How common was prosthesis-patient mismatch (PPM) after DurAVR (AVR) implantation?

PPM was reported as 1.5% at 30 days in the small-annulus cohort versus 11.2%–35.3% for current devices.

How many small-annulus patients were included in the DurAVR one-year pooled analysis?

The pooled cohort included 65 patients with small aortic annuli from EMBARK and a US early feasibility study.

Will the DurAVR one-year results be validated in a randomized trial?

Yes; outcomes will be further evaluated in the prospective randomized PARADIGM Trial (NCT07194265).