Orthocell has received regulatory approval for Remplir in Singapore. Pic: Getty Images
Health & Biotech
Special Report: Regenerative medicine company Orthocell has gained regulatory approval from Singapore’s Health Sciences Authority (HSA) for Remplir, enabling sales to start in Q1 CY25 and expanding the peripheral nerve repair product’s presence beyond Australia and New Zealand.
Orthocell Limited (ASX: OCC) said Singapore was a strategic regulatory market with the HSA’s approval for Remplir marking a major milestone for the company, which could be used as a stepping stone to approvals in other ASEAN markets such as Thailand, Malaysia, Vietnam, Indonesia and the Philippines.
Known for its efficiency, high standards and state of the art medical facilities, Singapore has become an important destination for medical treatment in the region.
The company said it was in advanced discussions with an experienced international medical device distributor ahead of the Singapore market launch anticipated early next year.
Remplir is a collagen wrap to augment nerve repair surgery and is approved for sale in Australia and New Zealand and distributed by Device Technologies, a respected name in the provision of medical devices.
OCC said it had been working with DVT to introduce Remplir, with 130+ orthopaedic and plastic surgeons across Australia and New Zealand now using Remplir in peripheral nerve repair surgeries.
Feedback from surgeons has been extremely encouraging, with product adoption strong according to the company, driven by Remplir’s unique qualities.
Remplir enables the reduction of damaging sutures, creation of an optimal healing microenvironment and facilitation of free gliding within the repair site during the critical healing period.
OCC is targeting a large addressable nerve repair market estimated to be worth more than US$3.5bn ($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.
OCC said its global regulatory strategy for Remplir continues to progress, with the company on track to receive regulatory clearance by the US Food and Drug Administration in Q1 CY25, providing access to the world’s largest healthcare market.
The company said applications were also planned for Canada, Thailand, EU and UK within the next 6-12 months.
OCC CEO and MD Paul Anderson said the company was delighted to receive Singaporean regulatory approval for Remplir in this important regional gateway market.
“This approval is further validation of Orthocell’s high-quality product, manufacturing processes and expanding global footprint,” he said.
The news comes on the back of OCC delivering a second consecutive quarter of record revenue, reporting $2.03m in Q1 FY25, up 7.82% on the $1.88m achieved in Q4 FY24.
“This approval strengthens our position to increase revenue and builds further confidence in our US FDA clearance anticipated in Q1 2025,” Anderson said.
“We are completely focused on growing revenue in our existing markets, as well as adding new jurisdictions, because we have absolute confidence in Remplir as a best-in-class product.
“We are seeing surgeons achieve consistent and predictable outcomes using Remplir, which is translating to growing revenues.”
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
