Regenerative medicine company Orthocell (ASX: OCC) will accelerate market expansion of Remplir ahead of US FDA clearance expected in March/April 2025.
A further five applications across Canada, Thailand, the United Kingdom, the European Union and Brazil are in progress for 2025. 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.
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.
Remplir approved for sale in Australia, New Zealand and Singapore and distributed by Device Technologies (DVT), a large and highly regarded distributor of high-quality medical devices. Its 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 excellent traction the product has gained since the 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.
Importantly, the company remains on track 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.
Approval is expected in March/April 2025 with sales to commence shortly thereafter. 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 commenced.