Anteris Technologies Reaches Clinical Milestone: 100 patients treated with DurAVR® THV
Anteris Technologies (NASDAQ/ASX: AVR) has announced a significant milestone with over 100 patients worldwide now treated using their DurAVR® Transcatheter Heart Valve (THV) for severe aortic stenosis. The treatment includes first-time cases, valve-in-valve patients, and complex bicuspid aortic valve cases.
Key clinical outcomes include:
- 65 patients completed primary endpoint measures showing safety and efficacy at 30 days
- 37 patients reached one-year follow-up, demonstrating sustained large effective orifice areas and low mean pressure gradients
- No valve or cardiovascular-related mortality reported at one-year
The company plans to commence the DurAVR® THV Pivotal Trial in Q3 2025, pending FDA approval. This trial will be an all-risk, head-to-head registration study, marking a significant step in the company's development of what they describe as the first new class of product in this space in many years.
Anteris Technologies (NASDAQ/ASX: AVR) ha annunciato un traguardo significativo con oltre 100 pazienti in tutto il mondo già trattati utilizzando la loro Valvola Cardiaca Transcatetere DurAVR® (THV) per stenosi aortica severa. Il trattamento include casi di prima volta, pazienti con valvola-in-valvola e casi complessi di valvola aortica bicuspide.
I principali risultati clinici includono:
- 65 pazienti hanno completato le misurazioni degli endpoint primari mostrando sicurezza ed efficacia a 30 giorni
- 37 pazienti hanno raggiunto il follow-up a un anno, dimostrando aree di orifizio efficace ampie e sostenute e bassi gradienti di pressione media
- Nessuna mortalità legata alla valvola o cardiovascolare riportata a un anno
L'azienda prevede di avviare il Trial Pivotal DurAVR® THV nel terzo trimestre del 2025, in attesa dell'approvazione della FDA. Questo trial sarà uno studio di registrazione a rischio totale, rappresentando un passo significativo nello sviluppo da parte dell'azienda di quella che descrivono come la prima nuova classe di prodotto in questo settore dopo molti anni.
Anteris Technologies (NASDAQ/ASX: AVR) ha anunciado un hito significativo con más de 100 pacientes en todo el mundo tratados con su Válvula Cardíaca Transcatéter DurAVR® (THV) para estenosis aórtica severa. El tratamiento incluye casos de primera vez, pacientes con válvula-en-válvula y casos complejos de válvula aórtica bicúspide.
Los principales resultados clínicos incluyen:
- 65 pacientes completaron las medidas de los puntos finales primarios mostrando seguridad y eficacia a los 30 días
- 37 pacientes alcanzaron el seguimiento a un año, demostrando áreas de orificio efectivo grandes y sostenidas y bajos gradientes de presión media
- No se reportó mortalidad relacionada con la válvula o cardiovascular a un año
La empresa planea iniciar el Ensayo Pivotal DurAVR® THV en el tercer trimestre de 2025, a la espera de la aprobación de la FDA. Este ensayo será un estudio de registro de riesgo total, marcando un paso significativo en el desarrollo de lo que describen como la primera nueva clase de producto en este espacio en muchos años.
Anteris Technologies (NASDAQ/ASX: AVR)는 전 세계적으로 100명 이상의 환자가 심한 대동맥 협착증 치료를 위해 DurAVR® 경피적 심장 판막 (THV)을 사용하여 치료받았다는 중요한 이정표를 발표했습니다. 치료에는 최초 사례, 밸브 내 밸브 환자 및 복잡한 이첨판 대동맥 판막 사례가 포함됩니다.
주요 임상 결과는 다음과 같습니다:
- 65명의 환자가 30일 기준으로 안전성과 유효성을 보여주는 주요 지표를 완료했습니다.
- 37명의 환자가 1년 후 추적 관찰을 받았으며, 지속적인 넓은 유효 개구면적과 낮은 평균 압력 기울기를 보여주었습니다.
- 1년 동안 판막 또는 심혈관 관련 사망 사례가 보고되지 않았습니다.
회사는 FDA 승인을 기다리며 2025년 3분기에 DurAVR® THV 주요 시험을 시작할 계획입니다. 이 시험은 전면적인 위험 등록 연구로, 이 분야에서 수년 만에 첫 번째 새로운 제품 클래스 개발에 있어 중요한 단계를 의미합니다.
Anteris Technologies (NASDAQ/ASX: AVR) a annoncé une étape importante avec plus de 100 patients dans le monde traités à l'aide de leur Valve Cardiaque Transcatheter DurAVR® (THV) pour une sténose aortique sévère. Le traitement comprend des cas de première fois, des patients avec valve dans valve, et des cas complexes de valve aortique bicuspide.
Les principaux résultats cliniques incluent:
- 65 patients ont complété les mesures des points finaux primaires montrant sécurité et efficacité à 30 jours
- 37 patients ont atteint le suivi d'un an, démontrant des zones d'orifice effectif larges et soutenues ainsi que de faibles gradients de pression moyens
- Aucune mortalité liée à la valve ou cardiovasculaire n'a été rapportée à un an
L'entreprise prévoit de commencer l'Essai Pivotal DurAVR® THV au troisième trimestre 2025, sous réserve de l'approbation de la FDA. Cet essai sera une étude d'enregistrement à risque total, marquant une étape significative dans le développement de ce qu'ils décrivent comme la première nouvelle classe de produit dans ce domaine depuis de nombreuses années.
Anteris Technologies (NASDAQ/ASX: AVR) hat einen bedeutenden Meilenstein bekannt gegeben, da weltweit über 100 Patienten mit ihrem DurAVR® Transkatheter-Herzklappe (THV) bei schwerer Aortenstenose behandelt wurden. Die Behandlung umfasst Erstfälle, Valve-in-Valve-Patienten und komplexe Fälle mit bikuspider Aortenklappe.
Wichtige klinische Ergebnisse umfassen:
- 65 Patienten haben die primären Endpunktmessungen abgeschlossen, die Sicherheit und Wirksamkeit nach 30 Tagen zeigen
- 37 Patienten erreichten die Nachuntersuchung nach einem Jahr und zeigten nachhaltige große effektive Öffnungsflächen und niedrige mittlere Druckgradienten
- Es wurden keine klappen- oder kardiovaskulär bedingten Todesfälle nach einem Jahr gemeldet
Das Unternehmen plant, die DurAVR® THV Hauptstudie im dritten Quartal 2025 zu beginnen, vorbehaltlich der Genehmigung durch die FDA. Diese Studie wird eine umfassende Risiko-Registrierungsstudie sein und stellt einen bedeutenden Schritt in der Entwicklung dessen dar, was sie als die erste neue Produktklasse in diesem Bereich seit vielen Jahren beschreiben.
- Successful treatment of over 100 patients demonstrates strong clinical adoption
- Excellent safety profile with no valve or cardiovascular mortality at one-year
- Positive efficacy data from 37 patients at one-year follow-up
- Versatility demonstrated through treatment of various patient types including complex cases
- FDA approval still pending for pivotal trial
- long-term data available (only 37 patients at one-year follow-up)
Insights
Anteris Technologies has achieved a significant clinical milestone with its DurAVR® Transcatheter Heart Valve (THV) now implanted in over 100 patients worldwide for aortic stenosis treatment. This includes first-time cases, valve-in-valve procedures, and complex anatomies like bicuspid aortic valve patients.
The data quality is particularly impressive: 65 patients have completed primary endpoint measures, demonstrating both safety and efficacy at 30 days. More compelling is the one-year follow-up data on 37 patients showing sustained large effective orifice areas and low mean pressure gradients - key hemodynamic parameters that indicate superior valve function compared to many existing solutions.
The excellent safety profile with no valve or cardiovascular-related mortality at one year is noteworthy in this patient population. This positions DurAVR® as potentially best-in-class for hemodynamic performance, which directly correlates with long-term patient outcomes.
Anteris remains on schedule to begin its pivotal registration trial in Q3 2025, pending FDA approval. This trial will be particularly significant as it's described as an "all-risk, head-to-head" study, suggesting direct comparison against established alternatives rather than just safety/performance endpoints. For a company of Anteris' size, successfully progressing to this stage represents substantial de-risking of their lead technology.
The clinical advancement of Anteris' DurAVR® valve represents a meaningful development in structural heart intervention. The biomimetic design approach differentiates this valve from current generation devices, potentially addressing limitations in hemodynamic performance that affect long-term outcomes.
What's clinically significant is the valve's performance across diverse patient anatomies, including the challenging bicuspid aortic valve population. These patients typically have asymmetric annuli that can compromise conventional valve deployment and function. The sustained hemodynamic benefits at one year - maintaining large effective orifice areas and low gradients - suggest potential for reduced patient-prosthesis mismatch, a common complication that necessitates future interventions.
The absence of valve-related mortality at the one-year mark is encouraging, though longer follow-up remains essential to evaluate durability. The upcoming pivotal trial will be crucial, as head-to-head comparisons against established valves will clearly define DurAVR®'s clinical advantages. For referring physicians, improved hemodynamics translate to better functional capacity and potentially reduced heart failure progression in aortic stenosis patients.
The involvement of Dr. Reardon, a respected figure in cardiovascular outcomes research, lends credibility to the clinical program. His emphasis on "rigorous scientific evaluation" suggests the upcoming trial will adhere to robust methodological standards necessary for regulatory approval and clinical adoption.
MINNEAPOLIS and BRISBANE, Australia, March 31, 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, 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 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 gradients (MPGs)
- Excellent safety profile demonstrated at one-year, with no valve or cardiovascular related mortality
- 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.
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@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 |
| https://www.linkedin.com/company/anteristech |
FAQ
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