OssDsign (OSSD) investor relations material

Market overview and clinical need

• Focus on the U.S. spinal fusion market, valued at $2.6 billion and growing at 8% annually.

• Spinal fusion procedures have a 20–30% failure rate due to avascular environments impeding bone growth.

• OssDsign Catalyst targets both vascular and avascular areas, aiming to improve fusion outcomes.

• Registry and clinical studies show high fusion rates, including challenging patient groups.

• Over 15,000 patients treated, with robust evidence supporting product efficacy.

Product performance and differentiation

• Catalyst demonstrated 80% fusion at 6 weeks and 100% at 26 weeks in preclinical studies.

• Achieved 93% fusion at 1 year and 100% at 2 years in first-in-human studies.

• Registry data showed 88.4% fusion in a broad, real-world patient population.

• Outperformed competitors in avascular environments in preclinical ovine studies.

• First synthetic bone graft to generate robust bone in avascular settings at early time points.

Strategic initiatives and growth plans

• Strategy update 'Scale to Profit' targets 2025–2028, focusing on U.S. market expansion.

• Plans to double sales force by end of 2026, with significant progress already made.

• Expanding product portfolio and indications, with new launches expected late Q4 or early Q1.

• Initiated a Level 1 randomized controlled trial to strengthen clinical evidence.

• Exploring U.S.-based production to support growth and mitigate risks.