Orthocell (OCC) Investor presentation summary

US FDA clearance and market opportunity

• Received US FDA 510(k) clearance for Remplir, enabling entry into the $1.6 billion US nerve repair market.

• Pre-launch activities completed, including presence at major US medical congress and engagement with key opinion leaders.

• Commercial distribution infrastructure in place, with warehousing and logistics ready for immediate order fulfillment.

• Internal sales, marketing, and medical education teams established, supported by a distributor network.

• Strong cash reserves (~$32M) and no debt support the US rollout.

Product innovation and clinical results

• Remplir is a collagen nerve wrap designed for peripheral nerve repair, offering compression-free protection and mimicking natural nerve structure.

• Demonstrated 85% functional recovery in clinical trials, with improved muscle strength and range of motion at 24 months.

• Versatile indications: connects severed nerves, protects damaged nerves, and caps amputated nerves.

• Over 180 surgeons and 150 hospitals currently use Remplir in existing markets.

• Addresses limitations of current devices, which are used in only ~10% of procedures and have integration challenges.

Manufacturing, logistics, and commercialization

• Scaled manufacturing facility in Australia with capacity for over 100,000 units annually and significant inventory.

• US-based warehousing at a GMP-certified facility ensures rapid, compliant order fulfillment.

• Stable product with no temperature control required and robust supply chain with backup suppliers.

• Hybrid sales model combines in-house team with external distributors, targeting rapid US market penetration.

• Experienced US-based executives appointed to lead sales, marketing, and medical affairs.