Orthocell Limited (ASX:OCC) Receives FDA Clearance for Remplir™
Regulatory Approval
Orthocell Limited has received US FDA 510(k) clearance for Remplir™, its flagship nerve repair product, allowing the commencement of commercial distribution in the US $1.6 billion nerve repair market.
Financial and Operational Readiness
The regulatory clearance is expected to significantly boost Orthocell’s revenue and facilitate a path to breakeven and profitability. The company is prepared with an annual manufacturing capacity of 100,000 units in Perth and no debt or royalty liabilities. Existing cash reserves of approximately $32 million fully fund the US roll-out and future commercial expansion.
Executive Comments
CEO and MD, Paul Anderson, said: “I’m delighted to announce we have received FDA clearance for our market-leading nerve repair product. We have been preparing in advance for this pivotal milestone, ramping up production from our facility in Perth and we have significant levels of inventory in place to deliver on early sales orders. Our sales, marketing and education team have made great progress identifying key opinion leaders, reputable reference sites and, most importantly, the distributors that we will work with to get Remplir into surgeons’ hands. We expect strong product adoption in the US, having experienced rapid sales traction in existing markets driven by the excellent feedback from surgeons in Australia, New Zealand and Singapore.”
Motley Fool contributor Abbie Stokes 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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