SI-BONE (SIBN) investor relations material

Strategic direction and innovation

• Strategy expanded from SI-joint dysfunction into pelvic fixation and trauma, targeting unmet needs and procedures with poor outcomes or high failure rates.

• Core capabilities include fixation and fusion in low-density bone, biomechanical and 3D-printing design, clinical evidence, and reimbursement supporting improved outcomes and healthcare economics.

• Focus is widening to compromised bone, including osteoporosis and osteopenia; Onyx is the first product outside the pelvis, with plans for one or two products annually, each addressing a new SAM.

• Management described a five-year innovation roadmap across compromised bone and said launches are typically discussed after development is well underway.

Onyx opportunity and launch

• Onyx targets UIV/LIV failure in complex fusion, where literature indicates ~27% failure; estimated opportunity is ~200,000 annual procedures, about one-quarter in deformity.

• FDA clearance came in late September 2026; the alpha launch showed use alongside Granite, in additional cases per physician, and by physicians who do not use Granite.

• Launch plan: beta through the quarter, full launch in Q1 2027, and surgical-capacity expansion through H1 2027; capacity is intended to support a stronger ramp in H2 2027.

• Deformity cases are expected to use four Onyx implants at $3,000 each; shorter constructs generally use two at $3,000 each. Some deformity cases may also use Granite.

• NTAP application, if approved, would take effect October 1, 2027; management views clinical need and DRG fit as the primary adoption drivers, not reimbursement as a gating factor.

Granite and reimbursement

• PAULA showed Granite use reduced revision rates from 24% to ~3% in the studied cases; Granite-specific revision was below 1%.

• New DRGs effective October 1 increased reimbursement by $20,000-$50,000; management expects clearer economics to ease adoption at new sites and support more consistent use and implants per case.

• DRG changes are permanent and not limited to Medicare; commercial coverage is expected to build over the next 12 months.

• The simpler DRG billing workflow and growing hospital awareness may support uptake; management expects the changes to bode well for the complex-fusion franchise in 2027.