Regenerative medicine company Orthocell Ltd (ASX:OCC, OTC:ORHHF) has passed a major milestone on its rapid commercialisation path with first sales of its leading peripheral nerve repair device Remplir™ in Singapore.
With the company’s recently appointed exclusive distribution partner Device Technologies Asia (DT Asia) taking first orders for Remplir, the device is now being sold in Singapore, Australia and New Zealand.
Sales of Remplir continue to grow with an increasing number of surgeons using and endorsing its unique repair qualities.
Sales well ahead of planned launch
As initial sales are well ahead of a planned Singapore market launch next quarter, Orthocell CEO and MD Paul Anderson said: “We are delighted to report first sales to DT Asia earlier than expected.”
He said this demonstrated the quality of the Remplir product and the strength of the company’s distribution partner Device Technologies Asia.
Strategic jurisdiction
Encouragingly for Orthocell, Singapore is a strategic jurisdiction as a destination for sophisticated medical treatments in the region and as a regulatory gateway to other substantial ASEAN markets, in a global nerve repair market estimated to exceed US$3.5 billion.
The company is progressing commercialisation in Singapore at a rapid pace rapidly with regulatory approval received in October 2024 through to first sales achieved in December 2024.
DT Asia is well placed to gain sales traction in this jurisdiction, having established relationships with target customers including leading plastic reconstructive and orthopaedic surgeons at high-quality surgical centres.
DT Asia distribution partner
The distribution partner will market and distribute Remplir for use in the surgical repair of peripheral nerves across Singapore, undertaking medical education, targeted promotion activities and initiating sales, as well as expanding the network of referring plastic and orthopaedic surgeons.
“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,” Anderson said.
“We expect additional sales, revenue growth and surgeon adoption of Remplir to accelerate in the new year,” he added.
Orthocell shares have been as much as 8% higher today to A$1.08 and have risen by more than 77% since November 21.
Sales increasing
Sales of Remplir have grown quickly in the Australian and New Zealand markets, with an increasing number of surgeons using and endorsing its unique repair qualities.
Singapore represents the first major international market launch outside the existing markets of Australia and New Zealand.
The rapid progression from Remplir’s recent regulatory approval from the Health Sciences Authority (HSA) in Singapore, to signing the distribution agreement with DT Asia, to early sales is validation of the company’s commitment to global expansion and revenue generation in new markets.
With circa $33 million in cash and no debt, Orthocell is well positioned to successfully launch Remplir in Singapore and other key markets including the United States, South East Asia, Canada and the EU/UK.
Importantly, the company remains on schedule to submit its Remplir US 510(K) application this quarter with progression into US FDA clearance and commercial distribution soon thereafter.
About Device Technologies Asia
Since 1992, DT Asia has remained committed to providing healthcare professionals with access to innovative, high-quality medical devices and solutions from around the world. DVT Asia’s vision is to enable superior health outcomes by connecting healthcare professionals with the finest medical technologies and supplies in the market.
The Device Technologies Group continues to grow, with 200+ trusted brands and 1,000 highly skilled staff across Australia, New Zealand and Asia.
All products distributed by Device Technologies are compliant with quality and regulatory requirements, with in-servicing, education and ongoing clinical and technical support provided as part of the trusted partnership between Device Technologies’ staff and healthcare professionals.