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
Peer-reviewed papers & conference abstracts via PubMed
Historical delivery and spending consistency — data is limited for recently added companies.
| 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 |
| 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 |
| PARADIGM trial enrollment milestones Quarterly enrollment updates for the 1,000-patient PARADIGM pivotal trial across US, Europe, Canada. First patients enrolled Oct 2025 in Denmark. | other | Confirmed | 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 |