Elutia (ELUT) investor relations material

Key technology and clinical need

• Drug-eluting biomatrix platform delivers sustained local antibiotics to prevent surgical infections.

• First-generation product was FDA-cleared, commercialized, and sold for $88 million.

• NXT-41x targets the $1.5 billion breast cancer surgery market with high unmet need and infection rates of 15%-20%.

• Local antibiotic delivery addresses the challenge of compromised blood supply post-mastectomy.

• Existing surgical techniques are used, making adoption seamless and cost-neutral for hospitals.

Market validation and surgeon feedback

• Independent survey of 50 surgeons found 86% believe current matrices increase infection risk.

• 96% rated the antibiotic combination in NXT-41x as effective; 100% would use it for high-risk patients.

• 92% of surgeons are willing to advocate for NXT-41x at hospital value analysis committees.

• Market is concentrated, with top 50 centers representing $300 million in annual revenue opportunity.

Regulatory and commercialization timeline

• NXT-41 (matrix only) submitted to FDA, with clearance expected in Q4 2026.

• NXT-41x (antibiotic version) expected to receive clearance in the first half of 2027.

• Soft launch planned for the second half of 2027, full commercial launch in 2028.

• Expansion planned into additional high-risk surgical markets, including hernia and abdominal wall repair.