BONESUPPORT (BONEX) CMD 2026 summary

Strategy and Market Focus

• Strategy is anchored in innovation, clinical evidence, and commercial execution, shifting to a segment-specific approach targeting foot & ankle, trauma, arthroplasty, and spine to unlock full potential.

• U.S. market opportunity has been revised upward to 460,000 procedures for 2025, reflecting higher revision arthroplasty volumes and increased infection rates.

• Penetration remains low in most segments, with highest share in diabetic foot and foot & ankle, while trauma and arthroplasty are still underpenetrated.

• Market research confirms high unmet clinical need and strong surgeon interest in local antibiotic solutions, especially for infection prevention and treatment.

• Spine is identified as a major future growth area, with investments in clinical studies and regulatory pathways targeting FDA submission by 2031.

Clinical Evidence and Product Differentiation

• CERAMENT’s unique biphasic technology enables bone healing and local antibiotic delivery, outperforming autografts, allografts, and systemic antibiotics.

• Clinical studies show significant reductions in infection recurrence and amputation rates in diabetic foot osteomyelitis, trauma, and arthroplasty cases.

• The SOLARIO trial demonstrated that short-duration systemic antibiotics with local CERAMENT are as effective as long-term regimens, reducing adverse events and costs.

• CERAMENT is the only FDA-approved antibiotic-eluting bone graft in the U.S., supported by patents, regulatory barriers, clinical evidence, and proprietary know-how.

• Ongoing and planned multicenter studies in foot & ankle, trauma, arthroplasty, and spine aim to expand indications and support market penetration, with new studies in arthroplasty and spine set for 2027.

Financial Performance and Investment Priorities

• Revenue has grown nearly sevenfold over five years, with U.S. CAGR at 55% and overall CAGR at 44% from 2020 to 2025.

• Operating leverage and cash conversion remain strong, with cash flow exceeding operational needs and enabling investments in R&D, clinical studies, and commercial expansion.

• Planned clinical investments include SEK 40 million for arthroplasty and SEK 80–90 million for spine studies, with regulatory submission for spine targeted by 2031.

• CMS reimbursement changes in 2026 could increase hospital payments by $5,000–$11,000 per procedure for CERAMENT G, supporting adoption.

• Share buybacks are authorized, reflecting strong cash generation and confidence in future growth.