OssDsign (OSSD) ABGSC Investor Days summary

Strategic transformation and business performance

• Shifted from cranio-patient-specific implants to a pure-play orthobiologics focus about a year ago, aiming for higher scalability and shareholder value.

• Achieved record growth: 121% in Q3, 145% in the first nine months, and 163% rolling 12 months, with 10 consecutive quarters of triple-digit U.S. growth.

• Gross margin reached nearly 97% in Q3, with guidance raised to above 93% going forward.

• Demonstrated significant operating leverage and reduced cash burn after closing the cranial business.

• U.S. market access expanded to about 150 hospitals, representing just under 10% of the total market.

Product differentiation and clinical results

• OssDsign Catalyst offers dual bone formation (inside-out and outside-in), outperforming both autograft and traditional synthetics in preclinical and clinical studies.

• Achieved 80% bone formation at six weeks in preclinical studies, compared to 40% for autograft and 20% for traditional synthetics.

• Clinical studies show 93% overall fusion rate, with early fusion observed at three months.

• Product mimics native bone at the micron level and incorporates silicate ions for enhanced performance.

• Superior intraoperative handling and resistance to irrigation cited as key surgeon adoption drivers.

Commercialization and market strategy

• Built a hybrid direct and distributor sales model, with only seven regional managers and a growing distributor network.

• Secured full military access and first large GPO contract, marking rapid commercialization.

• Clinical evidence base includes four peer-reviewed publications, four clinical white papers, and three preclinical publications.

• Ongoing data generation through the proprietary PROPEL spinal fusion registry, with plans to publish a cohort in the first half of next year.

• U.S. regulatory clearance allows for broader applications beyond spine, including pelvic, extremity, and trauma surgeries.