Orthocell Secures FDA Clearance for Remplir™, Targets $1.6B US Market as Shares Climb

Key Highlights:

• FDA clears Remplir™ for commercial sale in the US, unlocking $1.6B addressable market
• Shares trade at $1.46, up 279% YoY, with volume surging past 3.9 million
• US rollout team, logistics, and inventory fully in place
• Perth-based production facility ready to scale without further capex
   

Orthocell Ltd (ASX: OCC) delivered a major regulatory win on Thursday, announcing that it has secured US FDA 510(k) clearance for its flagship Remplir™ nerve repair device, opening the door to one of the world’s largest medtech markets.

Shares of Orthocell responded with enthusiasm, trading at $1.46, up 1.74% on the day, supported by robust trading volume of 3,963,813 shares—more than triple its 4-week average. The company now boasts a market capitalisation of $353.29 million, with a staggering 279.22% return over the past year, positioning it among the strongest-performing healthcare small caps on the ASX.

“This is a transformative moment for Orthocell,” said CEO Paul Anderson. “We’ve prepared aggressively for this milestone and are ready to execute in the US market.”

Remplir™ Takes Aim at High-Growth US Market

Remplir™, a collagen-based nerve wrap used during surgery to support nerve regeneration, is now approved for commercial sale across the US. It enters a US$1.6 billion market where demand for bioresorbable nerve repair devices is rising, but penetration remains low—estimated at just 10% of eligible procedures.

Orthocell’s proprietary SMRT™ technology, developed in partnership with the University of Western Australia, enables scalable, cost-efficient manufacturing. The company’s GMP-certified Perth facility is ready to supply up to 100,000 units annually, with no additional capital investment required for expansion.

“We’re not starting from scratch,” Anderson noted. “We have inventory, a trained US team, warehousing and distribution partners already set up.”

Strategic Rollout Already Underway

The company has assembled a US commercial team comprising senior leadership across sales, marketing, and medical affairs, supported by territory managers and 12 distribution partners expected within 6–12 months. This go-to-market structure is designed to drive surgeon engagement and rapid clinical adoption.

Orthocell anticipates that Remplir™ will find immediate traction in the US based on its positive surgeon feedback in Australia and Singapore, where the product has already been adopted in clinical settings.

“Our initial US revenues will be small but meaningful,” said Anderson. “We’re targeting rapid growth with a direct line of sight to break-even.”

Balance Sheet Strength Underpins Global Expansion

With $32 million in cash and no debt, Orthocell is entering this next phase from a position of strength. The company plans to extend regulatory filings to the EU, UK, Canada, and Thailand over the next 6–12 months, aiming to transform into a globally recognised regenerative medicine leader.

Orthocell’s FDA approval marks a decisive leap into the commercial mainstream. With a differentiated product, robust margins, and a ready-to-deploy US commercial strategy, the company is now poised to capitalise on years of R&D and market development.