SSII doubles revenue to $42.5M, files FDA 510(k), raises $18.6M; installed base triples to 168 systems

Filed March 10, 2026 · Period ending December 31, 2025 · Compared to 10-K Apr 15, 2025 · ~2 min read

Key Changes

• high

  Revenue more than doubled to $42.5M (from $20.6M) and net loss improved to $12.1M (from $19.2M), driven by installed base growing 171% to 168 systems across 153 hospitals. Procedures performed jumped 123% to 7,800+, including 400 cardiac surgeries.

  Business & MD&A: Revenue and Operations verify on EDGAR →
• high

  Company pivoted from de novo FDA pathway to faster 510(k) route and filed December 5, 2025 for multiple specialties. If approved, enables U.S. market entry in 2026 with lower regulatory risk and faster timeline than original de novo strategy.

  Business: FDA Regulatory Strategy verify on EDGAR →
• high

  Operating cash burn worsened to $18.5M (from $9.5M) despite improved net loss, as revenue growth consumed $13M in receivables and $8M in inventory. Company raised $28M convertible note from principal shareholder and $18.6M equity in March 2026 to fund expansion.

  MD&A: Cash Flow and Financing verify on EDGAR →