Regenerative medicine business Orthocell (ASX: OCC) has nailed down its first international regulatory approval for the group’s nerve repair product known as Remplir. The formal authorisation from the Health Sciences Authority in Singapore allows the company to begin sales in the nation and builds on its existing markets for the product in Australia and New Zealand.
First Remplir sales in Singapore are projected for early next year with Orthocell engaged in advanced discussions with an international medical device distributor ahead of the market launch.
Management believes Singapore represents a strategic jurisdiction for sophisticated medical treatments in Asia, and acts as a regulatory stepping stone to other significant markets in the region.
The landmark approval marks the first step in the group’s international regulatory drive as it targets authorisation for Rempil in the UK, continental Europe, Asia, Canada, and the lucrative US nerve repair market which Orthocell values at $1.6 billion. Regulatory clearance from the US Food and Drug Administration (FDA) is projected for the first quarter of 2025.
Globally, the market opportunity for Remplir is estimated to top US$3.5 billion per annum with up to two million peripheral nerve repair procedures anticipated to be performed each year across a host of nations.
Orthocell CEO and Managing Director, Paul Anderson, said:
“We are 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. This approval strengthens our position to increase revenue and builds further confidence in our US FDA clearance anticipated in Q1 2025.”
Remplir is a collagen nerve wrap manufactured through a proprietary SMRT manufacturing process. It assists surgeons in re-joining severed or damaged peripheral nerves to restore function and sensation in patients who have suffered nerve injuries through motor vehicle, sporting or work-related incidents.
According to Orthocell, the product aids surgeons in performing complex reconstructive surgical procedures with tensionless repair, which lowers the risk of additional damage to the nerve. It also helps to reduce the time needed to complete a surgery.
Management noted that Remplir is already gaining significant traction with new and existing surgeons in Australia and New Zealand, as showcased by record quarterly revenue generated from the product during the September quarter of the current financial year.
More than 130 orthopaedic and plastic surgeons across Australia and New Zealand are now using Remplir in peripheral nerve repair surgeries despite the Australian commercial launch of the product only enacted in late 2022.
According to the company, sales unit volumes have exceeded expectations with revenue of $1.0 million derived from Remplir during the 2024 financial year surging by 127% from twelve months prior.
More broadly, through the innovative SMRT manufacturing process, Orthocell develops collagen medical devices which help deliver high-quality surgical repair of bone, nerve, tendon and cartilage.
The company already generates revenue across the US, UK, Europe and Australia from its Striate+ product used for dental bone and tissue repair. Further expansion into Brazil and Singapore is also on the agenda as Orthocell looks to carve out a slice of a global market opportunity estimated at US$732 million in the dental barrier membrane market.
So far, Orthocell’s commercialisation push appears to be heading in the right direction with the company delivering about $6.8 million in total revenue during the 2024 financial year. This represents a healthy 31% jump from twelve months earlier and a compound annual growth rate of 93% since the 2022 fiscal year.
Additionally, the group is also eyeing a 2025 launch of its SmrtGraft tendon repair product in Australia, whilst continuing to progress its portfolio of other products towards monetisation. These include Orthocell’s medical devices for ligament replacement and its tendon cell therapy used to treat rotator cuff injuries.
Orthocell recently reported its second consecutive quarter of record revenue for the three months to September, after notching $2.0 million in total revenue during the period. In turn, the company’s share price has lifted by close to 50% since late August.
Latest posts by Gracen Moore (see all)
1 Comment
Shraddha13
Thank you for sharing! To explore further
Replyhttps://www.360iresearch.com/library/intelligence/nerve-repair-regeneration