Orthocell Secures Key Approval in Singapore for Nerve Repair Product Remplir™

2 min read | October 08, 2024 12:17 PM AEDT | By Team Kalkine Media

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Orthocell Secures Key Approval in Singapore for Nerve Repair Product Remplir™ — Image source: shutterstock

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Highlights

Orthocell receives regulatory approval in Singapore for its Remplir™ product.

Singapore acts as a gateway to other ASEAN markets for Orthocell.

Remplir™ targets a global market opportunity exceeding US$3.5 billion.

Orthocell Ltd (ASX:OCC) has announced that Singapore’s Health Sciences Authority (HSA) has granted regulatory approval for its innovative product, Remplir™, to be used in peripheral nerve repair. This marks the first international regulatory approval for Remplir™ outside of Australia and New Zealand, signaling a significant step forward for Orthocell in expanding its global reach.

Singapore holds strategic importance for Orthocell as a leading medical hub in the ASEAN region. The country’s approval is expected to pave the way for entry into other regional markets, such as Thailand, Malaysia, Vietnam, Indonesia, and the Philippines. Orthocell plans to begin sales of Remplir™ in Singapore early next year, further supporting the company’s strong revenue growth.

The global market opportunity for Remplir™ is estimated to exceed US$3.5 billion, and Orthocell is actively pursuing regulatory clearances in additional key markets, including the U.S., Europe, Canada, and other ASEAN nations. The U.S. market alone is valued at over $1.6 billion, with FDA approval anticipated in the first quarter of 2025.

Remplir™ has already gained traction in Australia and New Zealand, with over 130 orthopedic and plastic surgeons utilizing the product for nerve repair surgeries. The product’s design, which reduces the need for damaging sutures and facilitates optimal healing, has driven strong adoption and record revenue growth for Orthocell.

Orthocell’s CEO, Paul Anderson, expressed excitement about the Singapore approval, calling it a significant validation of the company's high-quality product and manufacturing processes. He highlighted the importance of this milestone as the company continues to expand its presence in existing and new markets, with a focus on building revenue and securing further regulatory clearances.

With the regulatory approval in Singapore, Orthocell is well-positioned to expand its footprint in the ASEAN region and beyond, strengthening its market presence for the Remplir™ product in the global nerve repair space.

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