Orthocell™ expands Remplir™ reach to more global markets

Orthocell Ltd chairman John Van Der Wielen talked with Proactive about the company’s latest international regulatory milestones, with Remplir™ now approved for sale in Canada and Thailand. These approvals significantly expand the company’s footprint, opening access to large and sophisticated healthcare markets.

Van Der Wielen explained that the successful regulatory applications were underpinned by strong clinical data and well-prepared submissions. “It seems to be becoming a trend at Orthocell™ where we're getting these approvals ahead of expectations,” he said.

The Canadian market is considered strategically important, aligning closely with healthcare systems in Australia and the US. According to Van Der Wielen, Canada’s market is “three or four times that of Australia,” and distribution negotiations are already underway with revenue expected in the second half of the year.

The Thailand approval was facilitated by prior authorisation in Singapore, showcasing the company’s ability to leverage regional approvals efficiently. Orthocell™ has now established a large international footprint, with Van Der Wielen emphasising a strategy focused on distribution-led entry rather than costly direct sales teams. He noted that Orthocell™ manufactures its own product, capturing margin and maintaining control over quality and supply.

Looking ahead, the company is targeting new applications in the UK and Europe, while also awaiting decisions from regulators such as Australia’s TGA for its SmartGraft tendon product. Van Der Wielen described the current stage as a shift “into the revenue and hopefully turning the profit” after over AUD 80 million in development investment.

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