Orthocell Ltd reports steady progress in commercialising its nerve repair product Remplir in the US, with sales growth, expanded distributor networks, and manufacturing upgrades underpinning its path to profitability.
- Remplir US sales growing steadily with 70% repeat surgeon use
- Cash breakeven targeted at under 1% of US peripheral nerve repair market
- Manufacturing expansion underway to quadruple capacity and reduce costs
- Fully funded with cash reserves expected to remain above $20 million
- Strategic hires and distributor network established across 45 US states
Orthocell's US Market Momentum
Australian medical technology company Orthocell Ltd has provided a comprehensive update on its US market progress for Remplir, its flagship nerve repair device. Following FDA approval, the company has made significant strides in establishing market access, growing its customer base, and scaling manufacturing capabilities. Orthocell estimates that achieving cash breakeven in the US requires capturing less than 1% of the addressable market, equating to approximately 10,000 unit sales annually.
Sales data to the end of December 2025 shows consistent revenue growth over the past three halves, driven by increasing device sales and surgeon adoption. Notably, around 70% of customers are repeat users, indicating strong product loyalty and clinical acceptance. Orthocell has secured state licensing in 45 US states and developed a distributor network comprising 16 partners covering both the East and West coasts, supported by a dedicated US sales team.
Strategic Investments Fuel Growth
Orthocell is investing heavily in expanding its manufacturing footprint to meet anticipated demand. A $5–5.5 million capital injection will fund office expansion, increased manufacturing and warehousing capacity, and automation projects designed to reduce cycle times and operating costs. These upgrades aim to quadruple current production capacity without increasing headcount in the medium term, enabling 24-hour operations and a more scalable supply chain.
The company’s financial position remains robust, with total cash reserves near $50 million and an expected cash balance above $20 million throughout the US rollout. This strong funding base supports Orthocell’s strategic focus on commercial leadership, clinical education, and product innovation as it seeks to build a global footprint with collagen-based medical devices.
Market Opportunity and Competitive Positioning
Peripheral nerve repair in the US represents a substantial market, with over 700,000 procedures annually. Currently, suturing remains the dominant technique, used in 90% of cases, while device adoption is limited to around 10%. Orthocell’s Remplir is positioned not to replace suturing but to offer a superior alternative to existing nerve repair devices, which suffer from rigidity, deployment challenges, and poor tissue integration.
Orthocell’s market access strategy involves surgeon engagement, training, and securing approvals from hospital Value Analysis Committees to enable funding pathways. With 71 VAC submissions and 27 approvals to date, including multi-site hospital groups, the company is building centres of excellence to drive adoption. The US launch is complemented by plans for expansion into Canada, Hong Kong, and the EU/UK markets in the near term.
Looking Ahead
Orthocell’s operational update underscores a disciplined approach to growth, balancing aggressive market penetration with sustainable investment in manufacturing and organisational capability. The company’s strengthened board and management team bring deep experience to navigate the complexities of the US healthcare market. As Orthocell advances its product pipeline and global expansion, the coming quarters will be critical in translating early momentum into lasting commercial success.
Bottom Line?
Orthocell’s US expansion is gaining traction, but the challenge remains to convert early adoption into sustained profitability.
Questions in the middle?
- How quickly can Orthocell scale Remplir sales beyond the initial 1% market share target?
- Will manufacturing upgrades deliver the anticipated cost efficiencies without operational disruptions?
- How will competitive dynamics evolve as other nerve repair technologies respond to Remplir’s entry?