Orthocell makes first sales of Remplir in Singapore after regulatory approval. Pic: Getty Images.
Health & Biotech
Special Report: Regenerative medicine company Orthocell (ASX:OCC) has announced first orders for its peripheral nerve-repair device Remplir from its recently appointed exclusive distribution partner Device Technologies Asia (DVT Asia).
The initial order follows regulatory approval from Singapore’s Health Sciences Authority (HSA) in October 2024 for Remplir, which is a collagen wrap to augment nerve-repair surgery.
Remplir has now been approved for sale in Australia, New Zealand and Singapore, and distributed by Device Technologies, a respected name in the provision of medical devices.
Orthocell said the initial sales have been received ahead of a planned Singapore market launch in Q1 CY25, demonstrating the quality of Remplir and strong market demand.
The company said DVT Asia was well placed to gain sales traction in the strategic market of Singapore having already established relationships with target customers including leading plastic reconstructive and orthopaedic surgeons at high-quality surgical centres.
DVT Asia will market and distribute Remplir for use in the surgical repair of peripheral nerves across Singapore, including undertaking medical education, targeted promotion activities, initiating sales and expanding the network of referring plastic and orthopaedic surgeons.
This early uptake is consistent with Orthocell’s KOL-engagement strategy, which has supported the company’s clinical impact and commercial traction in other key markets too.
Orthocell said Remplir sales have grown quickly in the Australian and New Zealand markets, with an increasing number of surgeons using and endorsing its repair qualities.
Singapore represents the first major international market launch outside Australia and New Zealand for the device.
Orthocell said known for its efficiency, high standards and state-of-the-art medical facilities Singapore had become an important destination for medical treatment in the ASEAN region.
The company said its HSA approval for Remplir could be used as a stepping stone to approvals of the device in other ASEAN markets such as Thailand, Malaysia, Vietnam, Indonesia and the Philippines.
OCC is targeting a large addressable global nerve-repair market estimated to be worth more than US$3.5 billion ($5.2bn) annually.
Around two million peripheral nerve repairs are estimated to be performed across Australia/New Zealand, Singapore, USA, EU/UK, Canada, Brazil, Japan and Thailand each year.
The company’s global regulatory strategy for Remplir continues to progress, with the company remaining on track to submit its US 510(K) application with the US Food and Drug Administration (FDA) in Q4 CY24.
Orthocell anticipates FDA clearance and commercial distribution in the US soon thereafter, providing access to the world’s largest healthcare market.
The company said with ~$33 million in cash and no debt the company was well positioned to successfully launch Remplir in key markets with regulatory applications also planned for Canada, Thailand, EU and UK in 2025.
“Device Technologies is our chosen distribution partner in Australia, New Zealand and Singapore and have moved quickly to begin selling our leading nerve-repair product Remplir in Singapore,” Orthocell CEO and managing director Paul Anderson said.
“We expect additional sales, revenue growth and surgeon adoption of Remplir to accelerate in the new year.”
This article was developed in collaboration with Orthocell, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
