SI‑BONE reports strong Q3 2026 results and launches iFuse Granite Onyx

SI‑BONE Inc. posted third‑quarter 2026 revenue of $55.7 million, up 14.5% year‑over‑year, with a 79.3% gross margin and a positive adjusted EBITDA of $3.0 million. The company received FDA 510(k) clearance for its new iFuse Granite Onyx platform, which it says expands its addressable market to roughly $5 billion. Management reaffirmed its full‑year 2026 revenue guidance and lowered its operating‑expense growth outlook to 10.5% while noting an ongoing recall of the iFuse TORQ implant system.

The reaffirmed revenue guidance and positive adjusted EBITDA suggest continued growth momentum, which analysts such as Canaccord Genuity note makes the 2026 guidance appear conservative. However, the TORQ recall introduces uncertainty about future revenue and margin impacts, which management says has not yet affected Q3 results.

  • 1Worldwide revenue was $55.7 million, a 14.5% increase from the prior year period.
  • 2U.S. revenue was $52.8 million, up 13.9% year‑over‑year.
  • 3Gross margin for the quarter was 79.3%.
  • 4Adjusted EBITDA turned positive at $3.0 million, a 32.4% improvement from the prior year quarter.
  • 5International revenue grew 27.0% to $2.9 million.
  • 6The iFuse Granite Onyx received FDA 510(k) clearance in September and is projected to add an estimated $5 billion total addressable market.
  • The potential revenue and margin impact of the ongoing iFuse TORQ recall is not quantified in the materials.

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