Orthocell Secures Landmark US FDA Clearance for Remplir™, Unlocking US Market
- StockSurge Team
- 4 days ago
- 2 min read
Orthocell (ASX: OCC) has received US FDA 510(k) clearance for its nerve repair product, Remplir™, opening access to the US$1.6 billion US nerve repair market and positioning the company for commercial expansion and a path to profitability.
What is Remplir™?
Remplir™ is a collagen nerve wrap designed to assist with the repair of peripheral nerve injuries. It protects nerves without compression, creating an optimal environment for healing. Using Orthocell’s proprietary SMRT™ manufacturing, Remplir™ preserves collagen structure for improved tissue integration.
Millions suffer nerve injuries yearly from accidents and workplace incidents, leading to pain, numbness, or paralysis. Many struggle with everyday tasks, and existing nerve repair surgeries have mixed success rates.
By reconnecting severed nerves, Remplir™ helps restore function and sensation, improving surgical outcomes.
Market Opportunity and Competitive Edge
The U.S. nerve repair market, valued at $1.6 billion, remains largely untapped, with device penetration at just 10%. This presents a major growth opportunity for Remplir™, which can expand without needing to compete against an entrenched market leader.
Orthocell’s Perth production facility, developed at the University of Western Australia, can produce 100,000 units per annum. The company controls all manufacturing, retains all product margins, and has no debt or royalty obligations.
Financial Strength and Growth Strategy
With A$32 million in cash reserves, Orthocell says it is fully funded for US expansion and additional roll outs into new markets such as Canada, Thailand, the EU, and the UK.
Orthocell has assembled a US-based team and distributor network, targeting 12 key partners within 6-12 months. The team has built relationships with top surgeons and hospitals to drive early adoption.
CEO and MD, Paul Anderson, said, "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."
Remplir™ is lightweight, has a three-year shelf life, and is easily shipped via air freight, simplifying logistics. Beyond the US, Orthocell says the global nerve repair market is estimated to exceed US$3.5 billion.
The company is also advancing its broader regenerative medicine portfolio, including Striate+™ for dental applications and SmrtGraft™ for tendon repair.
