Orthocell Soars 11.6% on Canadian Regulatory Win for Flagship Nerve Repair Device

Key Highlights:

• OCC surges to $1.635 as Health Canada approves Remplir™ for nerve repair
• Total addressable market for Remplir now tops US$1.8 billion
• OCC stock delivers 325% return over 12 months; market cap approaches $400M
   

Orthocell Ltd (ASX: OCC) rallied 11.6% to $1.635 on Tuesday following news that Health Canada has granted regulatory approval for its nerve repair product Remplir™, unlocking immediate access to the country’s US$75 million nerve repair market. The approval further expands Orthocell’s international footprint and bolsters its potential for commercial acceleration in 2025.

With this clearance, Remplir™ is now licensed for sale across six markets: the U.S., Australia, New Zealand, Singapore, Thailand, and now Canada. The total addressable market for the device in approved regions is estimated to be US$1.8 billion, with applications in the EU and UK still pending submission over the next 6–12 months.

Investors responded with enthusiasm, sending Orthocell’s share price to fresh highs within a 52-week range of $0.35 to $1.79. The company now boasts a market cap of $395.6 million, driven by mounting confidence in its global rollout strategy and ability to monetise its regenerative medicine platform.

CEO Paul Anderson welcomed the news, stating: “We’re building a significant portfolio of jurisdictions for Remplir, and Canada is another critical piece. Every regulatory milestone increases the overall value of our portfolio and helps establish global market credibility.”

Importantly, Orthocell plans to leverage non-exclusive specialist distributors to penetrate the Canadian market, while keeping internal commercial efforts laser-focused on the U.S.—the largest and most strategically vital region.

The company remains well-funded with $31.7 million in cash and no debt, providing ample runway for commercial expansion and clinical development. Revenue from newly approved markets is expected to commence in H2 2025, with distribution agreements currently under negotiation in Canada.

Orthocell’s broader product suite—comprising Striate+™ for dental reconstruction and SmrtGraft™ for tendon repair—is also gaining momentum. Its regenerative cell therapies are undergoing development with U.S. market entry discussions underway.

With a 12-month return of over 324%, Orthocell has outpaced the healthcare sector by a wide margin. As the company transitions from regulatory wins to revenue generation in North America and beyond, investor sentiment is clearly shifting from potential to performance.