• Orthocell wins Singaporean approval for its Remplir nerve-repair product
• Lumos wraps up $10 million whip-round amid surge of raisings in the sector
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It’s not the US approval Orthocell (ASX:OCC) has been angling for, but Singaporean assent for the company’s nerve regeneration product Remplir opens the door for the company to enter other Asian markets.

Shares in the Perth-based Orthocell entered trading halt late yesterday pending a “Remplir regulatory approval”, which some investors may have posited was the coveted nod from the US Food & Drug Administration.

Instead, the Lion City’s Health Sciences Authority has allowed Remplir to be used for peripheral nerve repair.

A collagen wrap, Remplir fosters an “optimal healing microenvironment” with minimal use of sutures.

The company notes the approval is the first from a key regulatory agency outside of Australia and New Zealand, where the product already is used.

“Singapore is a strategic regulatory jurisdiction, both as a destination for sophisticated medical treatments in the region and as a regulatory gateway to other substantial ASEAN markets,” the company says.

(The key ASEAN markets are Thailand, Malaysia, Vietnam, Indonesia and the Philippines).

Orthocell puts the “global market opportunity” for Remplir at US$3.5 billion, with the US accounting for US$1.6 billion.

FDA approval is expected in the March quarter of 2025.

In Singapore, the company is in advanced chats with an “experienced international distributor” in view of launching Remplir in the same quarter.

In the meantime, Remplir is being used by around 130 orthopaedic and plastic surgeons locally and in NZ.

Orthocell shares this morning gained 6% to 51c.

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