Orthocell Limited (ASX:OCC) Reports First US Remplir™ Sales Revenue

US Sales Revenue Achieved

Orthocell Limited (ASX: OCC) has recorded its first US sales revenue from its flagship Remplir™ nerve repair product, following its initial surgical use on 26 June in Ohio and subsequent cases in Florida.

Strategic Market Expansion

The achievement marks Orthocell’s transition from receiving US FDA 510(k) clearance for Remplir™ to generating revenue in just over three months. Early-stage surgeries in US Ambulatory Surgery Centers are crucial for building experience within the significant US$1.6 billion market.

Order Fulfilment and Logistics

The company has validated its order fulfilment and customer invoicing workflow. Remplir™ US inventory is managed and shipped by logistics partner Uniphar.

Financial Position

Orthocell maintains a strong balance sheet with approximately $28.6 million in cash as at 30 June 2025 and no debt, positioning it well to expand its commercial footprint and grow revenues in existing and new markets.

Executive Comments

CEO Paul Anderson stated, “Translating Remplir’s regulatory clearance in the US to first sales revenue in a little over three months is a testament to the hard work we’ve done with our US rollout plan. This covers everything from our key internal hires in sales, marketing and medical affairs, appointing specialist distributors, Australian manufacturing ramp-up, and working with our on-the-ground US logistics partner. I must stress these early-stage day surgery cases are an ideal starting point and represent the perfect strategic platform to build from. This approach is similar to the market access model we have successfully undertaken in Australia, where early surgery cases build familiarity and knowledge, leading to widespread adoption and therefore revenue growth. We expect to follow a similar path in the US, albeit on a far larger scale. We are confident our efforts in the US are on track to drive growth in sales of Remplir during the second half of calendar 2025.”

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Motley Fool contributor Lauren Surplice has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has recommended Orthocell. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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