Clinical ResultsAn 81% disease control rate and measurable tumor responses in the first-in-human pancreatic study signal promising clinical activity that could translate into meaningful benefit for patients with limited treatment options.
Manufacturing And SupplyAwarding of a radioactive material license in New Hampshire, plans for additional production sites with substantial output capacity, and U.S. manufacturing slated to begin in 2026 support the company’s readiness to scale supply for commercialization.
Regulatory ProgressSubmission of a PMA module and FDA acceptance of a modular review, together with Breakthrough Device designation and multiple IDE approvals, reflect regulatory momentum that could accelerate access if pivotal data confirm safety and effectiveness.