Question · Q3 2026
Yale Chen asked for elaboration on the Gen 2 system's potential for extended service intervals, whether this testing is required before FDA review, and if the Phase 1b oncology study might start later this calendar year given the company's improved cash position.
Answer
Steve Lisi, CEO, explained that the Gen 1 system requires service every 1,000 hours, which is an expensive process. The Gen 2 system is projected to extend this interval to at least 3,000 hours, potentially longer, which will improve gross margins. He clarified that while there's an FDA reliability hurdle already passed, ongoing testing for longer intervals is for internal service guidance, not FDA approval. Regarding the oncology study, Lisi stated they are exploring options but are not committing to a timeline, prioritizing commercial operations with the current balance sheet and likely not fully funding the study until closer to profitability.
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