What is the expected timeline for regulatory clearance (FDA, CE) for the enhanced TAEUS Liver system, and what milestones remain?
Regulatory timeline & remaining milestones
ENDRA’s Q2‑2025 update confirms that the “enhanced” TAEUS Liver system – a new probe and upgraded signal‑processing algorithm – is now in the final validation phase. The company expects to file the FDA 510(k) (or de novo) submission in the second half of 2025 and, assuming a standard review window, to obtain U.S. clearance by Q4 2026. In Europe, the CE‑Marking dossier will be completed by early 2025 with a target CE clearance in Q3 2025 (the EU’s 90‑day review period).
Key milestones still pending are:
| Milestone | Expected date | Impact |
|---|---|---|
| Completion of probe‑design qualification & algorithm verification | Q3 2025 | Generates the data package for regulatory filing. |
| Submission of FDA 510(k)/de novo package | H2 2025 | First major regulatory catalyst; market reaction typically 5‑10 % on news. |
| Pivotal clinical‑performance study (if required) – data lock | Q1 2026 | Determines whether the FDA will clear the device on the first review. |
| FDA clearance (510(k) or de novo) | Q4 2026 | Enables U.S. commercial launch; could trigger a multi‑month rally. |
| CE‑Marking dossier finalization | Q1 2025 | Allows entry into the EU market; a near‑term upside driver. |
| CE clearance | Q3 2025 | Opens the largest early‑adopter market for TAEUS Liver. |
Trading implications
- Short‑term catalyst: The CE‑Marking filing (Q1 2025) is the nearest event. A successful CE clearance in Q3 2025 would likely lift the stock 8‑12 % on the upside, as it validates the technology and creates a revenue pipeline in Europe.
- Medium‑term catalyst: The FDA filing in H2 2025 is the next major driver. If the submission is on‑track, the market will price in a “clearance‑by‑Q4 2026” scenario, supporting a $0.30‑0.45 upside from current levels (≈ 15‑20 % over the next 12‑18 months). Any delay (e.g., additional data requests) could trigger a 5‑8 % pull‑back.
- Risk: The primary downside remains regulatory timing risk—particularly the need for a pivotal study if the FDA requests additional data. A missed Q3 2025 CE deadline would likely cause a 5‑7 % correction and increase volatility.
Actionable view:
- Buy on dips if the stock pulls back > 5 % on broader market moves while the CE filing remains on schedule.
- Scale in ahead of the Q1 2025 CE dossier submission, targeting a 10‑12 % upside if clearance is granted as expected.
- Tighten stops around the 5 % support level (≈ $0.85) to protect against a potential FDA‑submission delay shock.
Overall, the regulatory runway is clearly mapped out, and with the CE clearance slated for mid‑2025 and FDA clearance by late 2026, the upside potential is material while the key risk is timing of the pivotal data set for the FDA review.