What is the anticipated timeline for regulatory approval of the PEDD™ technology for thyroid applications?

Regulatory timeline: In its press‑release, Tri Salus notes that the safety‑and‑efficacy data for the Pressure‑Enabled Drug Delivery™ (PEDD™) thyroid embolization technique have just been published in a peer‑reviewed journal. The company explicitly states that it expects to file a regulatory submission to the U.S. Food & Drug Administration within the next 12‑18 months and projects potential FDA clearance by late 2025 (subject to standard review timelines). This timeline is consistent with the company’s broader roadmap for its PEDD™ platform, which targets a series of indication‑specific submissions over the next 2‑3 years.

Trading implications: The upcoming regulatory milestone is a near‑term catalyst. If Tri Salus can keep to its “late‑2025” target, the stock could experience a price‑run‑up in the 3‑6 months leading up to the FDA filing as investors price in the probability of a successful approval. Conversely, any delay beyond the 12‑month window could trigger a short‑term pullback, especially if competing thyroid‑intervention technologies (e.g., radiofrequency ablation, laser ablation) continue to gain market share. Traders should watch for: (1) the filing of an Investigational New Drug (IND) or Pre‑Market Approval (PMA) dossier, (2) any FDA feedback or request for additional data, and (3) the company’s upcoming earnings call where management is likely to provide a concrete timetable. A prudent strategy is to buy on pull‑backs after the filing if the data remain robust, while keeping a tight stop‑loss in case the FDA requests a longer clinical‑data package or imposes a delayed timeline.