Highlights

Orthocell generates its first U.S. revenue from flagship nerve repair product, Remplir™.

Sales follow initial surgical procedures in Ohio and Florida using distributor network.

U.S. commercial rollout achieved within three months of FDA clearance.

Orthocell Limited (ASX:OCC) has announced its first U.S. sales revenue from its collagen-based nerve repair product Remplir™, marking a key commercial milestone just over three months after receiving U.S. FDA 510(k) clearance. This transition into revenue generation follows the product’s first surgical application in Ohio on 26 June, with further procedures taking place in Florida.

Remplir™ is now in clinical use at multiple U.S. sites via Ambulatory Surgery Centers—outpatient facilities known for rapid adoption of novel technologies. These early-stage procedures are part of a strategic approach aimed at building surgeon familiarity and clinical experience across the U.S. healthcare network. The U.S. market for nerve repair is estimated to be worth US$1.6 billion, with the global market opportunity valued at over US$3.5 billion.

The successful commencement of sales also validates the operational framework developed by Orthocell for U.S. distribution, including order fulfillment and invoicing. Logistics are being handled by Uniphar, the company’s on-the-ground distribution partner in the U.S., enabling inventory management and timely delivery to clinical sites.

Orthocell’s Managing Director and CEO, Paul Anderson, noted that the rapid progression from FDA clearance to first revenue demonstrates the effectiveness of the company’s commercial rollout strategy. “These initial surgeries represent the ideal starting point for our U.S. expansion. By beginning with outpatient surgical centres, we can quickly introduce Remplir™ into clinical workflows and build awareness among surgeons,” he said.

He added that Orthocell's rollout plan includes key hires in U.S.-based sales, marketing, and medical affairs, alongside expanded Australian manufacturing capabilities to support anticipated demand. According to Anderson, the commercialisation approach mirrors the successful strategy executed in Australia, which led to increased clinical uptake and revenue growth.

Remplir™ is a collagen-based medical device used in peripheral nerve repair to enhance the regeneration of damaged nerves. It has been clinically shown to outperform traditional suture-only repair techniques in terms of tissue quality and speed of recovery. The product is approved for use in the U.S., Australia, New Zealand, and Singapore.

The company is targeting a wide geographical footprint, estimating that approximately two million peripheral nerve repair procedures are performed annually across its addressable markets, including the U.S., EU, UK, Canada, Brazil, Japan, and parts of Southeast Asia.

Orthocell’s broader product portfolio includes Striate+™ for dental applications, and SmrtGraft™ for tendon repair, among others. The company reported AUD 28.6 million in cash at bank as of 30 June 2025 and carries no debt, positioning it well to fund further expansion across its core product lines.

On the back of this announcement, Orthocell’s share price rose 3.89% to AUD 1.27 on 10 July 2025.