Persistent Cash BurnMaterial negative operating and free cash flows across multiple years show the business currently consumes capital faster than it generates it. This chronic cash burn creates sustained financing dependence, increases dilution risk, and constrains strategic flexibility unless a durable shift to positive FCF occurs.
Fragile Capital BaseAlthough reported debt is low, accumulated losses produced deeply negative equity in prior years and highly variable returns. That history reflects a fragile capital base that can require future equity raises, diluting shareholders and limiting the company’s ability to absorb clinical or commercial setbacks long-term.
Regulatory Setback & Longer TimelinesRegulatory questions forced halting the first-generation pathway and expanding the pivotal study to roughly 800 patients for a second-gen device. This materially extends development timelines, increases clinical costs, and concentrates program risk on successful larger trials, delaying sustainable commercial revenue.