Orthocell (OCC) Investor presentation summary

US commercialisation progress

• Achieved first surgical use in the US within three months of FDA 510(k) clearance, targeting a $1.6 billion addressable market.

• Fourteen specialist distributors appointed, covering 25 states with a focus on the east coast.

• Internal sales, marketing, and medical education teams are closely engaged with distributors, with tailored business plans and ongoing sales force training.

• Logistics provider in place, with 2,000 units shipped and warehoused at a US GMP-certified facility.

• Sales ramp-up expected in 1H FY26, with all key workstreams progressing on track.

Product features and clinical results

• Remplir is a collagen nerve wrap designed for peripheral nerve repair, providing compression-free protection and mimicking the nerve's outer layer.

• Clinical results show 85% of nerve repairs resulted in functional muscle recovery within 24 months.

• Interim study results indicate earlier return of function, higher quality nerve regeneration, and no inflammatory response compared to suture-only repairs.

• Over 200 surgeons and 165 hospitals use Remplir in existing markets for trauma, compression, and amputation cases.

Market opportunity and competitive landscape

• US peripheral nerve repair market sees over 700,000 procedures annually, with 90% using suture-only methods and success rates of 50–70%.

• Remplir targets the 10% of procedures using devices, addressing limitations of current products such as rigidity and poor tissue integration.

• No dominant incumbent in the device segment, presenting significant growth potential.