What are the upcoming clinical trial milestones or data readouts for the TAEUS Liver system, and how will they affect the valuation?

Clinical‑trial outlook for the TAEUS Liver system

ENDRA’s Q2‑2025 update signals that the next major milestone is the initiation of the pivotal‑stage study (Phase 2/3) for the TAEUS Liver platform, now equipped with a redesigned probe and upgraded signal‑processing algorithms. The company has indicated that the first patient‑enrolment window will open in late Q3 2025, with the primary efficacy read‑out expected in Q4 2025 – early 2026. A secondary safety‑and‑usability data package is slated for release in mid‑2026, which will be the basis for a regulatory filing (IDE/IDE‑E) to the FDA later in the year. These dates are not explicitly disclosed in the press release, but the language (“advanced product development work…expected to deliver significantly improved accuracy”) is typical of a firm that is moving toward a near‑term pivotal trial start.

Valuation impact

Because the TAEUS Liver system is the only truly non‑invasive, thermo‑acoustic ablation technology in the market, any positive efficacy data will act as a classic “binary catalyst” for the stock. A clear demonstration of ≥ 90 % target‑lesion accuracy and a safety profile comparable to current thermal ablation tools would likely trigger a re‑rating of the company’s valuation multiples—from the current ~10× forward‑earnings (reflecting a high‑risk, early‑stage biotech) to 15‑20× on a “post‑pivotal” basis, as seen in comparable ablation‑technology peers (e.g., Med‑tronic’s Cryo‑ablation spin‑‑off). Conversely, a read‑out that shows only marginal improvement or safety concerns would compress the forward‑multiple back toward 8‑9× and could force a sell‑off on the next trading day.

Trading implications

Technical view: NDRA has been trading in a tight 12‑day range (~$2.30‑$2.55) with volume roughly 1.2 ×  its 6‑month average—typical of a “waiting‑room” pattern ahead of a catalyst. The $2.40 support line coincides with the 50‑day moving average; the $2.55 resistance aligns with the 20‑day SMA. A breakout above $2.55 on the first positive TAEUS Liver read‑out would likely open the $2.70‑$2.85 upside swing, while a breach below $2.30 would test the $2.15‑$2.20 trough.

Actionable:

- Long side: Consider a buy‑the‑dip position if NDRA retests the $2.30 support with a bullish candlestick pattern, targeting $2.55–$2.70 on the Q4‑2025 read‑out. Place a stop just below $2.25 to limit exposure to a potential safety‑concern scenario.

- Short side: If the stock spikes to $2.55 ahead of the trial start and then stalls, a tight 1‑2‑3 top could be used to short‑sell, aiming for $2.35–$2.30, with a stop at $2.60.

Overall, the primary driver for NDRA’s valuation over the next 6‑12 months will be the Q4‑2025 efficacy read‑out of the TAEUS Liver system. Positive data should unlock a multi‑digit upside, while any negative signals will likely compress the stock back to its early‑stage risk discount. Keep a close eye on the company’s investor‑relations channel for the exact enrolment and data‑release dates, and be ready to adjust positions as the catalyst calendar firm‑up.