Orthocell ramps up global expansion of market-leading regenerative medicine products

Orthocell has seven regulatory applications in progress or planned in large and attractive new markets
As Striate+ gains traction in various markets, the company is accelerating market access into Brazil and Singapore
Remplir product regulatory approval in Singapore anticipated within six months and US FDA approval expected within nine months

Special Report: Regenerative medicine company Orthocell is accelerating market expansion of its market-leading Striate+ and Remplir products with seven regulatory applications either in progress or planned for these platform devices.

Orthocell (ASX:OCC) has ramped up efforts to tap into the lucrative global markets for its two key products – Striate+ for guided bone and tissue regeneration in dental implant procedures and Remplir for peripheral nerve repair.

The move follows strong uptake from key opinion leading clinicians and sales traction driven by its appointed distributors. Earlier this month, Orthocell announced record revenue in FY24, and a balance sheet of $20.6 million – a compelling position to broaden its commercial footprint.

OCC says Striate+ has gained excellent traction in the US, EU/UK and Australia, where it has regulatory approval, and has recently been approved in Canada.

The company is now working to accelerate access into the large markets of Brazil and Singapore, with regulatory approvals anticipated within 6-12 months.

OCC says it’s also working with exclusive global distribution partner BioHorizons to achieve further Striate+ regulatory approvals into multiple new markets.

Remplir is also gaining strong traction in Australia. Regulatory approval in Singapore is anticipated within six months and US FDA approval is expected within nine months.

A further three regulatory applications are planned for submission in Canada, Thailand, and EU/UK in the coming months.

OCC says the combined global market opportunity for the two products is ~US$3bn, with the company targeting a 20% market share for both products.

The biotech says effective expansion into other markets would see an increase in these projections, demonstrating enormous growth potential for OCC in the near term.

98% success rate for Striate+

Striate+ is a collagen barrier membrane used to support guided bone and tissue regeneration in dental implant procedures.

It is distributed globally by one of the largest global dental implant companies, BioHorizons Implant Systems Inc.

BioHorizons undertook a successful US product launch of Striate+ in November 2022, with a focus on supplying existing key opinion accounts and other major customers.

OCC says strong sales traction for Striate+ in existing markets of Australia, the US and EU/UK has resulted from BioHorizon’s comprehensive marketing and medical education program along with the outstanding 98.6% success rate observed in the product’s post-market clinical study.

Striate+’s high-quality performance is driving BioHorizons’ pursuit of other large, attractive markets where they have established accounts and/or distribution networks including Singapore and Brazil.

OCC and BioHorizons are targeting large, addressable markets with ~5.5 million dental membranes estimated to be used in dental guided bone and tissue regeneration and implant procedures per annum in existing US, EU/UK, Australia, and Canada markets and planned markets of Brazil and Singapore.

Source: Orthocell

Redefining Nerve Repair with Remplir

Remplir is a collagen wrap used to augment nerve repair surgery and is approved for sale in Australia and New Zealand.

Orthocell’s nerve regeneration program remains a market favourite, with the share price soaring over 300% off the back of previous clinical data.

The product is now distributed by Device Technologies, which launched Remplir in Australia in November 2022.

120+ orthopaedic and plastic surgeons across Australia and New Zealand now using the product in peripheral nerve repair surgeries, after a ramp up in uptake over the past 18 months.

OCC says feedback and uptake by surgeons have been very encouraging, driven by Remplir’s unique qualities.

They include reducing damaging sutures, creating the optimal healing microenvironment, and facilitating free gliding within the repair site during the critical healing period.

OCC says its global expansion strategy for Remplir continues to build, with the company on track to receive regulatory clearance from the US FDA in Q1 CY25.

Regulatory approval for Remplir in Singapore is expected in H2 CY24, following an application to the Health Services Authority in Singapore in January 2024.

OCC says approval in Singapore is considered the gateway to other ASEAN markets, including Thailand, Malaysia, Vietnam, Indonesia, and the Philippines.

The company has a further three regulatory applications for Remplir planned in Canada, Thailand, and the EU/UK within the next 6-12 months.

OCC is also targeting large addressable markets for Remplir, with ~1.6m peripheral nerve repairs estimated across existing Australia and planned markets of Singapore, USA, Canada, Thailand, and EU/UK.