Orthocell’s Remplir™ Nerve Repair Device Debuts in $1.6B US Market Post-FDA Clearance

Orthocell’s Breakthrough Enters US Market

Orthocell Limited (ASX – OCC) has achieved a significant commercial milestone with the first surgical use of its flagship nerve repair product, Remplir™, in the United States. This landmark procedure, performed in Ohio shortly after the product’s US Food and Drug Administration (FDA) clearance in April 2025, marks the beginning of Orthocell’s entry into the lucrative US nerve repair market, estimated at US$1.6 billion.

Remplir™ is a collagen-based wrap designed to enhance nerve regeneration and improve patient outcomes following peripheral nerve injuries. Supported by robust clinical evidence, including studies demonstrating its superiority over traditional suture techniques, Remplir™ promises earlier functional recovery and higher quality nerve tissue repair.

Strategic Distribution Network Fuels Early Adoption

Orthocell has strategically appointed 14 specialist distributors across 25 states, leveraging established relationships with surgeons and hospitals to accelerate product adoption. The first surgery in Ohio was directly facilitated by one such distributor, underscoring the effectiveness of this network in translating regulatory approval into clinical use.

Orthocell’s in-house marketing, medical affairs, and sales teams are actively collaborating with distributors to build surgical familiarity and confidence in Remplir™. Early clinical cases are critical not only for patient outcomes but also for cultivating surgeon experience and advocacy, which are essential for broader market penetration.

Financial Strength Supports Growth Ambitions

With approximately AU$30 million in cash reserves and no debt, Orthocell is well-positioned to support the US rollout and expand its commercial footprint. The company anticipates reporting initial sales growth in the first half of fiscal year 2026, reflecting the momentum generated by this first surgical use and ongoing distributor engagement.

Beyond the US, Orthocell targets a global nerve repair market exceeding US$3.5 billion, spanning multiple regions including Australia, New Zealand, Europe, and Asia. The successful US launch of Remplir™ could serve as a catalyst for further international expansion.

Looking Ahead

Orthocell’s CEO and Managing Director, Paul Anderson, emphasised the significance of this milestone as the start of a broader commercial journey. The company’s focus now turns to scaling surgeon adoption and translating clinical benefits into sustained sales growth in the world’s largest healthcare market.