Orthocell soars 14% after crushing early sales growth for Remplir

Early sales transaction has been achieved for Remplir across major jurisdictions
A global expansion is underway to increase revenue opportunities
The company is planning to broaden its commercial footprint in existing and new markets

Special Report: Regenerative medicine company Orthocell is up ~14% today after announcing it will speed up efforts to enter several key markets across CY25 including Thailand, Canada, the UK, Brazil and European Union following a third quarter of record revenue.

The market expansion of Remplir, a collagen wrap used in nerve repair surgery, will now be accelerated ahead of US Food and Drug Administration (FDA) clearance expected in March/ April.

Orthocell (ASX:OCC) is confident the growth in these markets will increase revenue opportunity to circa US$3.2bn, where it is targeting a 20% market share.

Remplir is approved for sale in Australia, New Zealand and Singapore and distributed by Device Technologies, a large distributor of high-quality medical devices.

The product’s unique qualities, allowing less suturing, creation of an optimal healing microenvironment and facilitation of free gliding in the repair site during the critical healing period, has contributed to the traction it has gained since its Australian market launch in November 2022.

There are ~160 orthopaedic and plastic surgeons now using Remplir in peripheral nerve repair surgeries from facial nerves to upper and lower limb nerves across Australia, New Zealand and Singapore.

US expansion

OCC says it remains on track to achieve clearance to commercially distribute Remplir into the US, the largest and highest value nerve repair market – estimated to be worth about US$1.6bn per annum.

Preparations for US market launch are well advanced, with recently appointed experienced US-based executives, John Walker and Phillip Edmondson, driving the go-to-market strategy.

Recruitment of the initial sales team, key opinion leader engagements, distributor appointments and initiating medical education and advocacy programs to support early sales has begun.

An extremely strong performer in the ASX biotech sector

Perth-headquartered Orthocell was a hero of the ASX healthcare sector in 2024. The company is up more than 265% in the past year and ~20% over the past month.

Orthocell sits among the top five performing ASX healthcare stocks of the past year.

Source: Market Index

With a strong balance sheet of ~$33m, OCC is well funded to continue broadening its commercial footprint.

The company is targeting large addressable markets with ~1.8m peripheral nerve repairs estimated across existing and planned markets.

Effective expansion into other markets would see an increase in these projections, demonstrating significant growth potential for the company in the near term.

As it stands, global commercialisation is fast tracking in five jurisdictions while the regulatory submission for Thailand is targeted for end of March.

The UK and EU is targeted for the September quarter, followed by Brazil in the December quarter.

In addition to these planned submissions, OCC is investigating other ASEAN countries including Taiwan, Vietnam, Indonesia and the Philippines. as well as Latin American markets.

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