Anteris Reports One-Year Patient Outcomes for DurAVR® THV
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) announced one-year results for its DurAVR® Transcatheter Heart Valve (THV) System at Sydney Valves on March 21, 2025. The data demonstrates sustained favorable hemodynamic performance with an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient of 8.6 + 2.6 mmHg, and Doppler Velocity Index of 0.58.
Key highlights include:
- No valve or cardiovascular-related mortality at one year
- Zero prosthesis-patient mismatch (PPM) in small annuli patients
- 65 patients completed the primary endpoint measure at 30 days
The results are particularly significant as current commercial devices show PPM rates between 11.2% to 35.3%. The company plans to include this data in their upcoming FDA Investigational Device Exemption submission for the DurAVR® THV randomized, global pivotal study.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) ha annunciato i risultati annuali per il suo DurAVR® Transcatheter Heart Valve (THV) System durante il Sydney Valves il 21 marzo 2025. I dati dimostrano un'ottima performance emodinamica sostenuta con un Effective Orifice Area (EOA) di 2.1 + 0.2 cm2, un Gradiente di Pressione Medio di 8.6 + 2.6 mmHg e un Indice di Velocità Doppler di 0.58.
I punti salienti includono:
- Nessuna mortalità correlata alla valvola o cardiovascolare a un anno
- Zero mismatch prostesi-paziente (PPM) nei pazienti con anelli piccoli
- 65 pazienti hanno completato la misura del punto finale primario a 30 giorni
I risultati sono particolarmente significativi poiché i dispositivi commerciali attuali mostrano tassi di PPM tra l'11.2% e il 35.3%. L'azienda prevede di includere questi dati nella prossima presentazione per l'Investigational Device Exemption della FDA per lo studio globale randomizzato e cruciale del DurAVR® THV.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) anunció los resultados de un año para su DurAVR® Transcatheter Heart Valve (THV) System en el Sydney Valves el 21 de marzo de 2025. Los datos demuestran un rendimiento hemodinámico favorable sostenido con un Effective Orifice Area (EOA) de 2.1 + 0.2 cm2, un Gradiente de Presión Media de 8.6 + 2.6 mmHg y un Índice de Velocidad Doppler de 0.58.
Los aspectos destacados incluyen:
- Ninguna mortalidad relacionada con la válvula o cardiovascular a un año
- Cero desajuste prótesis-paciente (PPM) en pacientes con anillos pequeños
- 65 pacientes completaron la medida del punto final primario a los 30 días
Los resultados son particularmente significativos ya que los dispositivos comerciales actuales muestran tasas de PPM entre el 11.2% y el 35.3%. La empresa planea incluir estos datos en su próxima presentación de Exención de Dispositivo de Investigación a la FDA para el estudio pivotal global aleatorizado del DurAVR® THV.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR)는 2025년 3월 21일 시드니 밸브에서 DurAVR® 경피 심장 판막 (THV) 시스템의 1년 결과를 발표했습니다. 데이터는 유효 개구 면적 (EOA) 2.1 + 0.2 cm2, 평균 압력 기울기 8.6 + 2.6 mmHg 및 도플러 속도 지수 0.58로 지속적인 유리한 혈역학적 성능을 보여줍니다.
주요 하이라이트는 다음과 같습니다:
- 1년 동안 판막 또는 심혈관 관련 사망 없음
- 작은 판막의 환자에서 제로 보철물-환자 불일치 (PPM)
- 65명의 환자가 30일에 주요 종결점 측정을 완료함
현재 상용 장치의 PPM 비율이 11.2%에서 35.3% 사이인 점에서 결과는 특히 중요합니다. 회사는 DurAVR® THV 무작위 글로벌 주요 연구를 위한 FDA 조사 장치 면제 제출에 이 데이터를 포함할 계획입니다.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) a annoncé les résultats d'un an pour son DurAVR® Système de Valve Cardiaque Transcatheter (THV) lors des Sydney Valves le 21 mars 2025. Les données montrent une performance hémodynamique favorable soutenue avec une Surface d'Orifice Efficace (EOA) de 2.1 + 0.2 cm2, un Gradient de Pression Moyen de 8.6 + 2.6 mmHg et un Indice de Vitesse Doppler de 0.58.
Les points clés incluent:
- Aucune mortalité liée à la valve ou cardiovasculaire après un an
- Zéro décalage prothèse-patient (PPM) chez les patients avec de petits anneaux
- 65 patients ont complété la mesure du critère principal à 30 jours
Les résultats sont particulièrement significatifs car les dispositifs commerciaux actuels montrent des taux de PPM entre 11.2% et 35.3%. L'entreprise prévoit d'inclure ces données dans sa prochaine soumission à la FDA pour l'Exemption de Dispositif d'Investigation pour l'étude pivotale mondiale randomisée du DurAVR® THV.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) gab am 21. März 2025 die Ergebnisse für ein Jahr seines DurAVR® Transkatheter-Herzklappen-Systems (THV) beim Sydney Valves bekannt. Die Daten zeigen eine nachhaltige günstige hämodynamische Leistung mit einer Effektiven Öffnungsfläche (EOA) von 2.1 + 0.2 cm2, einem mittleren Druckgradienten von 8.6 + 2.6 mmHg und einem Doppler-Geschwindigkeitsindex von 0.58.
Wichtige Highlights sind:
- Keine valve- oder kardiovaskulär bedingte Sterblichkeit nach einem Jahr
- Null Prosthesis-Patienten-Mismatch (PPM) bei kleinen Annuli-Patienten
- 65 Patienten haben den primären Endpunkt nach 30 Tagen erreicht
Die Ergebnisse sind besonders signifikant, da aktuelle kommerzielle Geräte PPM-Raten zwischen 11.2% und 35.3% zeigen. Das Unternehmen plant, diese Daten in seiner bevorstehenden FDA-Antrag auf Genehmigung eines Prüfgeräts für die randomisierte, globale Hauptstudie des DurAVR® THV aufzunehmen.
- Zero prosthesis-patient mismatch (PPM) vs. 11.2-35.3% in current devices
- No valve or cardiovascular-related mortality at one year
- Sustained favorable hemodynamic performance
- High implant success across clinical program
- Small patient sample size of only 65 patients
- Still requires FDA approval for pivotal study
Insights
The one-year clinical data for Anteris' DurAVR® THV represents a significant advancement in transcatheter aortic valve technology. The sustained hemodynamic performance metrics—EOA of 2.1 cm², MPG of 8.6 mmHg, and DVI of 0.58—demonstrate excellent blood flow characteristics that have maintained consistency over the one-year period.
The complete absence of prosthesis-patient mismatch (PPM) in small annuli patients is the standout finding. This is technically challenging to achieve and clinically meaningful, as PPM occurs when the prosthetic valve's effective orifice area is too small relative to the patient's body size. Competing devices show PPM rates of 11.2-35.3%, making Anteris' achievement exceptional.
Small annuli patients represent a particularly challenging subgroup in the TAVR population, often experiencing suboptimal outcomes with current technologies. The zero PPM rate directly addresses an established predictor of valve failure and disease progression, potentially translating to improved long-term survival and reduced reoperation rates.
While the 65-patient sample size is relatively small, the consistent safety profile with no valve-related mortality strengthens the positive signal. The upcoming IDE submission to the FDA represents a critical regulatory milestone toward pivotal trials, though market approval remains distant pending successful completion of randomized studies.
Anteris' one-year DurAVR® THV data demonstrates potential differentiation in the competitive TAVR market. The complete elimination of prosthesis-patient mismatch (PPM) in small annuli patients addresses a significant unmet clinical need and creates a compelling value proposition against established players.
Current TAVR market leaders continue to struggle with PPM rates between 11.2-35.3% in challenging anatomies. By solving this specific limitation, Anteris could potentially capture share in the small annuli segment, which represents a substantial portion of the TAVR-eligible population.
The sustained hemodynamic performance at one year validates the durability of their proprietary ADAPT® tissue technology and biomimetic valve design. The EOA of 2.1 cm² is particularly impressive for small annuli patients, exceeding what's typically achievable with existing technologies in this anatomical subset.
The advancement toward IDE submission signals progression along the regulatory pathway, though several years of development remain before potential commercialization. With 65 patients completing the primary endpoint measure, the data provides confidence for initiating larger pivotal trials.
While early-stage, these results suggest Anteris is developing a potentially disruptive technology addressing a specific limitation of current market offerings rather than simply creating an incremental improvement.
New class, biomimetic TAVR demonstrates sustained hemodynamic performance to one-year
MINNEAPOLIS and BRISBANE, Australia, March 21, 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, today announced one-year results for patients treated with its proprietary, balloon expandable, DurAVR® Transcatheter Heart Valve (THV) System. Rishi Puri, M.D. PhD presented 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 cm2, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler Velocity Index (DVI) of 0.58.
- 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 small annuli patients (aortic annulus area 395.80 + 37.26mm2).
Current commercial devices have demonstrated rates between11.2% to35.3% PPM1, a predictor of valve failure and disease progression.
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.
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.
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| investor@anteristech.com | mchatterjee@bplifescience.com | |
| Debbie Ormsby | Malini Chatterjee, Ph.D. | |
| Anteris Technologies Global Corp. | Blueprint Life Science Group | |
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FAQ
What are the one-year performance results of Anteris' DurAVR THV System (AVR)?
How does DurAVR's prosthesis-patient mismatch rate compare to other TAVR devices (AVR)?
How many patients completed the primary endpoint in the DurAVR study (AVR)?
What is Anteris' next regulatory step for DurAVR (AVR)?
