Orthocell's US Debut: First Surgical Use of Remplir Opens $1.6 Billion Market

Orthocell (ASX: OCC) has crossed a major commercial threshold with the first surgical use of its nerve repair product, Remplir™, in the United States. The operation, completed in an Ohio hospital, marks the first application of Remplir following its US FDA clearance in April 2025—and places the Perth-based regenerative medicine outfit squarely in the running for a slice of the US$1.6 billion American nerve repair market.

The procedure was observed by Orthocell’s medical education team and utilised product manufactured at the company’s facility in Western Australia. The initial case, which addressed a foot nerve injury, was sourced via one of Orthocell’s 14 specialist distributors, who collectively cover 25 states and are tasked with embedding Remplir in surgical practice across the country.

For CEO Paul Anderson, this isn’t just a clinical milestone—it’s a strategic inflection point. “This first US surgery is a significant milestone for Orthocell and for the roll out of Remplir™ in the US. It signals the start of our commercial journey in the world’s largest healthcare and nerve repair markets,” Anderson said.

Remplir is a collagen-based nerve wrap designed to enhance the regeneration of damaged peripheral nerves. Backed by clinical evidence, it has been shown to outperform conventional suture techniques in functional recovery and nerve tissue quality. With approximately two million peripheral nerve repairs conducted annually across key global markets, the addressable market is estimated at over US$3.5 billion.

In the US context, early adoption is key. While regulatory approval opens the door, it’s surgeon familiarity and demonstrable patient outcomes that determine how wide it swings. Anderson stressed the strategic value of these early surgical cases, which help “build experience and knowledge amongst the surgical community.”

The company’s approach is refreshingly straightforward: start small, build confidence, and expand the rollout. The initial focus is on generating traction with specialist nerve surgeons, supported by in-house sales and medical affairs staff. Orthocell expects this groundwork to translate into sales growth in the first half of FY26.

Backed by around AU$30 million in cash and zero debt, Orthocell is well-positioned to fund the US push. Beyond Remplir, the company’s broader portfolio includes Striate+ (a dental collagen membrane already cleared in multiple markets), SmrtGraft for tendon repair, and autologous cell therapies for tendon and cartilage regeneration.

For now, all eyes are on Remplir. With regulatory boxes ticked, distributors engaged, and now the first patient treated, Orthocell’s entry into the US is no longer hypothetical. It’s happening, scalpel in hand. If uptake continues to build, the company could well find itself not just exporting collagen wraps, but becoming a staple name in global surgical circles.