Regenerative medicine company Orthocell (ASX:OCC) says commercialisation of its flagship nerve repair product Remplir in the US is progressing on plan, with early clinical use and steps to secure broader hospital adoption underway.
The company reported that ten US surgeries using Remplir have now been completed as surgeons gain familiarity with the product. Orthocell said those early procedures mirror the pattern seen in prior launches in Australia and Singapore, where early clinical experience helped drive later adoption and revenue growth.
Orthocell has submitted 36 applications to hospital Value Assessment Committees (VACs) and has so far received three approvals. VACs evaluate requests to introduce new products, services, or technologies to hospitals by assessing clinical effectiveness, safety, and cost-effectiveness, an approval pathway Orthocell described as critical to achieving wider uptake across the US hospital system.
The targeted hospitals were identified through Orthocell’s US distributor network, which spans 25 states. The company said distributor relationships have enabled it to nominate specific surgeons at those hospitals to recommend and support VAC submissions.
To support procedures in the US, Orthocell has shipped 4,000 Remplir units to its US logistics partner Uniphar. All units were manufactured at the company’s facility in Western Australia. Orthocell also expanded its US presence with two new hires, including a regional sales director with direct experience in the nerve repair market.
“We continue to make excellent progress in the US with surgeons building familiarity through early surgical procedures,” Orthocell CEO Paul Anderson said. “We’ve seen the strategic importance of these early procedures in our successful market launches of Remplir in Australia and Singapore. Our network of distributors remains an important avenue to market and they have been instrumental in identifying key hospitals for us to target VAC approvals. This is the next important step for us in order to achieve more widespread adoption of Remplir, which in turn will drive revenue generation for Orthocell.”