Structural heart company developing DurAVR, a biomimetic transcatheter aortic valve using proprietary ADAPT tissue technology, currently enrolling the global PARADIGM pivotal trial backed by a strategic partnership with Medtronic.
No capital raise or buyback data
Historical delivery and spending consistency. Data is limited for recently added companies.
Outcome quality (positive/negative readouts) reflects the science, not execution — shown above but excluded from the score.
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Peer-reviewed papers & conference abstracts via PubMed
| Event | Type | Confidence | Impact | Date | Status |
|---|---|---|---|---|---|
| Medtronic co-commercialization agreement details Formal commercial/manufacturing partnership terms expected to be announced. Medtronic holds 16.2% equity (US$90M, Jan 2026) with board observer rights. | partnership | Expected | arrow_upwardHigh | 30 Sept 2026 | Upcoming |
| TCT 2026 DurAVR clinical data presentation Annual Transcatheter Cardiovascular Therapeutics conference; ongoing DurAVR clinical data updates and PARADIGM progress. TCT 2025 featured one-year small annuli outcomes. | conference presentation | Confirmed | removeMed | 31 Oct 2026 | Upcoming |
| CMS coverage determination decisionopen_in_new CMS coverage determination expected to facilitate site adoption and recruitment for the PARADIGM Trial in the United States. [Source: Results for the First Quarter of 2026, 2026-05-12] | regulatory decision | Expected | arrow_upwardHigh | 31 Dec 2026 | Upcoming |
| PARADIGM interim 6-month safety data Early hemodynamic and safety signal updates as first patients reach 6-month mark in the PARADIGM trial. Non-inferiority vs. commercial TAVR devices. | data readout | Expected | removeMed | 31 Dec 2026 | Upcoming |
| European CE Mark approval for DurAVR CE Mark for commercial sales in EU/EEA; European trial sites active in Denmark. Expected in parallel to FDA PMA pathway. | regulatory decision | Expected | arrow_upwardHigh | 30 June 2027 | Upcoming |
| PARADIGM primary endpoint data (1-year) Composite endpoint: all-cause mortality, all stroke, cardiovascular hospitalization at one year vs. commercially available TAVR devices. Pivotal trial result. | data readout | Expected | arrow_upwardHigh | 30 Sept 2027 | Upcoming |
| FDA PMA approval for DurAVR US marketing approval contingent on PARADIGM trial results. Timeline assumes smooth trial progression with no safety signals. | regulatory decision | Speculative | arrow_upwardHigh | 31 Dec 2027 | Upcoming |
| DurAVR® Transcatheter Heart Valve (THV) ANSM — PARADIGM - French Regulatory Clearanceopen_in_new Anteris Technologies received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for the DurAVR® THV global pivotal trial (PARADIGM Trial). This clearance enables patient recruitment to commence at leading centres in France as part of the company's broader clinical and regulatory strategy. | regulatory decision | Confirmed | removeMed | 8 June 2026 | Completed |
| Prospectus Supplement and Sales Agreementopen_in_new Anteris Technologies has established a $250 million at-the-market (ATM) equity offering with TD Securities, allowing the company to sell common stock opportunistically through Nasdaq and ASX. The offering provides capital flexibility for the structural heart company developing its lead DurAVR® transcatheter heart valve product. | other |
| removeMed |
| 24 May 2026 |
| Completed |
| Results for the First Quarter of 2026open_in_new Anteris reported Q1 2026 results with US$320 million capital raise completed in January 2026 to support the PARADIGM Trial. The company advanced patient enrollment across Europe and recently commenced U.S. enrollment, with CMS coverage determination expected to facilitate site adoption and recruitment. | other | Confirmed | removeMed | 12 May 2026 | Completed |
| Quarterly Results Announcement and SEC Form 10-Qopen_in_new Anteris Technologies (AVR) filed Q1 2026 quarterly results showing a structural heart medical device company in development stage. Related party payments totaled US$2.3 million during the quarter, comprising director fees and executive compensation. The company remains focused on commercializing its DurAVR® Transcatheter Heart Valve for aortic stenosis treatment. | other | Confirmed | removeMed | 12 May 2026 | Completed |
| PARADIGM trial enrollment milestonesopen_in_new First US patients have been enrolled in the PARADIGM Trial, marking the initiation of enrollment activities for the 1,000-patient pivotal study across US, Europe, and Canada. | other | Confirmed | removeMed | 5 May 2026 | Completed |