Orthocell Secures Singapore Regulatory Approval for Nerve Repair Product, Remplir™

Key Points:

1. Orthocell has secured regulatory approval in Singapore for its nerve repair product, Remplir, marking the first major international clearance outside of Australia and New Zealand.
2. The company is in advanced discussions with an international distributor, aiming for market entry in Singapore early next year, with plans to expand into other ASEAN markets.
3. Orthocell is targeting a global peripheral nerve repair market valued at over USD 3.5 billion, with regulatory clearances in the U.S., Canada, EU, UK, and Thailand expected in the next 6-12 months.

Orthocell Limited (ASX:OCC), a leading company in regenerative medicine, has announced a major milestone with the regulatory approval of its flagship product, Remplir™, by Singapore's Health Sciences Authority (HSA). Remplir, a collagen wrap designed to aid in peripheral nerve repair surgeries, has now received its first significant international approval outside Australia and New Zealand, where it is already commercially available.

Strategic Approval and Market Expansion

The approval in Singapore represents a crucial step in Orthocell’s international growth strategy. The company is set to commence sales in Singapore early next year, marking another key region for revenue generation. Orthocell is currently in advanced discussions with an experienced international distributor to fast-track the initial sales in Singapore, ensuring swift entry into the market.

Singapore’s approval is strategically significant for Orthocell as it can serve as a gateway to broader ASEAN markets, including Thailand, Malaysia, Vietnam, Indonesia, and the Philippines. Singapore's reputation for stringent regulatory standards and state-of-the-art medical facilities positions it as a key medical hub in the region, making it an ideal launchpad for further expansion in Asia.

Remplir: Enhancing Nerve Repair

Remplir is a medical collagen wrap used to augment nerve repair surgeries by creating an optimal healing environment. Its innovative design reduces the need for potentially harmful sutures while promoting free movement and gliding of the nerve during the critical healing process. Currently, Remplir is approved for sale in Australia and New Zealand, where it is distributed by Device Technologies (DVT). Since its launch, more than 130 orthopedic and plastic surgeons have adopted Remplir in nerve repair procedures, giving the product strong traction in the market.

The feedback from surgeons has been overwhelmingly positive, with many highlighting the product’s unique ability to improve surgical outcomes and facilitate healing. The product’s adoption is driven by its ability to minimize the use of sutures, which can cause damage, and its creation of a microenvironment that supports efficient nerve recovery.

Global Growth and Regulatory Strategy

In addition to the Singapore approval, Orthocell is aggressively pursuing regulatory clearances in key international markets. The company anticipates receiving approval from the U.S. Food and Drug Administration (FDA) in the first quarter of 2025, marking another significant opportunity for market expansion. Applications for Remplir are also in progress for other important markets, including Canada, the European Union, the United Kingdom, and Thailand, with approvals expected over the next 6 to 12 months.

The global market for peripheral nerve repair is substantial, estimated to be worth over USD 3.5 billion. There are approximately two million peripheral nerve repairs performed annually in key markets such as Australia, New Zealand, Singapore, the U.S., EU, UK, Canada, Brazil, Japan, and Thailand. As Orthocell continues its regulatory push, it is positioning itself to capture a meaningful share of this growing and lucrative market.