Orthocell Raises $30M to Accelerate US Rollout of Nerve Repair Innovation

Orthocell has raised $30 million through an institutional placement to accelerate the US commercialisation of its flagship nerve repair product Remplir and expand its regenerative medicine portfolio.

  • Raised $30 million via institutional placement at $1.30 per share
  • Funds to accelerate US rollout of Remplir post-FDA clearance in 2025
  • Expansion of manufacturing capacity from 100,000 to 400,000 units annually
  • Clinical studies targeting prostate cancer surgery applications
  • Company to hold over $50 million cash with zero debt post-placement
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Orthocell’s Strategic Capital Raise

Orthocell Limited (ASX, OCC), a regenerative medicine company focused on tissue repair, has announced a $30 million institutional placement to accelerate the commercialisation of its nerve repair product Remplir in the United States. The placement, priced at $1.30 per share, a modest 9.1% discount to the last traded price, reflects strong demand from both domestic and international investors, including new US institutional participants.

This capital injection will significantly bolster Orthocell’s balance sheet, leaving the company with over $50 million in cash and no debt, positioning it strongly to execute its global growth strategy.

Accelerating US Market Penetration

Remplir, Orthocell’s flagship product for peripheral nerve repair, has already demonstrated robust growth with six consecutive quarters of record revenue, reaching $3 million in the September quarter, primarily from Australia and Singapore. The US rollout, following FDA clearance expected in April 2025, is progressing ahead of schedule.

Orthocell has established a nerve repair specialist distributor network covering 25 states and approximately 40% of the US population. To date, over 40 surgeries have been performed across multiple hospitals with more than 100 surgeons introduced to Remplir. The company has also secured 14 Medical Advisory Board members and lodged 51 Value Analysis Committee applications with hospitals, with 11 approvals granted and state licenses underway.

Expanding Manufacturing and Clinical Development

The proceeds from the placement will enable Orthocell to expand its manufacturing capacity at its Western Australian facility from 100,000 to 400,000 units annually, a critical step to meet anticipated demand from the US and other markets.

In addition to scaling production, Orthocell plans to undertake clinical studies to support the use of Remplir in prostate cancer surgeries, a significant market opportunity given the prevalence of prostate cancer and the potential for nerve repair to improve patient outcomes.

Beyond nerve repair, the company is advancing its pipeline in tendon, ligament, and bone regenerative medicine, signaling a broader ambition to diversify its product offerings within the regenerative medicine sector.

Leadership Perspective and Market Outlook

CEO and Managing Director Paul Anderson emphasized the momentum behind Remplir’s commercialisation and the strategic importance of the capital raise. He highlighted the strong endorsement from new US investors as a vote of confidence in Orthocell’s near-term revenue prospects and long-term growth strategy.

With a robust cash position and no debt, Orthocell is well-positioned to accelerate its US market penetration and invest in promising new applications, potentially reshaping treatment paradigms in nerve and soft tissue repair.

Bottom Line?

Orthocell’s $30 million raise sets the stage for a rapid US expansion, but clinical and regulatory milestones will be key to sustaining momentum.

Questions in the middle?

  • How quickly will US revenue from Remplir ramp up following FDA clearance?
  • What are the timelines and expected outcomes for the prostate cancer surgery clinical studies?
  • How competitive is the US nerve repair market, and what differentiates Remplir?