Buoyed by early sales traction for Remplir™ described as “outstanding”, Orthocell Ltd is accelerating its global commercial expansion strategy into multiple key jurisdictions ahead of US FDA clearance which is expected in March/April 2025.
The sales growth in the Australia, New Zealand and Singapore markets is evidenced by a third consecutive quarter of record revenue and the company is making plans to enter a number of other key markets across 2025 including Canada, Thailand, United Kingdom (TADAWUL:4280), European Union and Brazil.
Lifting revenue opportunity
Expansion into these markets will significantly increase the revenue opportunity for the company to circa US$3.2 billion, where the company’s is targeting a 20% market share.
Other ASEAN and Latin American markets are also under evaluation as the regenerative medicine company plans to build on the early momentum.
Global regulatory strategy for Remplir 2025-2026.
About Remplir
Remplir is a collagen wrap used in nerve repair surgery and is intended to assist surgeons to improve outcomes in the repair and regeneration of damaged nerves.
Approved for sale in Australia, New Zealand and Singapore, Remplir is distributed by Device Technologies(DVT), a large and highly regarded distributor of high-quality medical devices.
Orthocell said Remplir’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, had contributed to the traction the product had gained since the Australian market launch in November 2022.
About 160 orthopaedic and plastic surgeons are using Remplir in peripheral nerve repair surgeries, from facial nerves to upper and lower limb nerves, across the three markets.
Key move into US
A key next move for the company is to achieve clearance to commercially distribute Remplir into the USA, the largest and highest value nerve repair market, estimated to be worth ~US$1.6 billion US per annum.
Preparations are well advanced and approval is expected in March/April 2025 with sales to begin shortly thereafter.
Newly appointed experienced US-based executives John Walker and Phillip Edmondson are driving the go-to-market strategy while recruitment of the initial sales team, key opinion leader engagements, distributor appointments and initiating medical education and advocacy programs to support early sales are underway.
Other markets
Orthocell is moving rapidly in a bid to maintain the sales momentum of Remplir by accelerating global commercialisation.
The application for a Medical (TASE:PMCN) Device Licence from Health Canada is well advanced and is expected to be lodged shortly while a regulatory submission for Thailand is targeted for end of the March quarter.
Also on the expansion pathway are regulatory submissions for the UK and EU which are targeted for the September quarter of 2025, followed by Brazil in the December quarter.
In addition to these planned submissions, the company is investigating other ASEAN markets such as Taiwan, Vietnam, Indonesia and Philippines as well as Latin American markets.
Well-positioned
Supporting the intentions to continue to broaden the company’s commercial footprint and grow revenues in existing and new markets, is a strong balance sheet with approximately $33 million cash at bank.
Orthocell is targeting large addressable markets with ~1.8 million peripheral nerve repairs estimated across existing (Australia, NZ and Singapore) and planned markets (USA, Canada, Thailand, EU/UK & Brazil).
The combined global market opportunity for Remplir is estimated to be approximately US$3.2 billion (circa A$5 billion) with Orthocell targeting a 20% market share.
Effective expansion into other markets would see an increase in these projections, demonstrating strong near-term growth potential.