Latest Regenerative Medicine News

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

Orthocell Limited has posted a record quarterly revenue of A$2.73 million, driven by strong Australian sales of its nerve repair product Remplir™, with US market expansion poised to accelerate in FY26.

Cambium Bio has secured ethics approvals in Australia and the US to initiate pivotal Phase 3 trials of Elate Ocular, targeting moderate to severe dry eye disease, with patient dosing expected in October 2025.

Orthocell has marked a pivotal milestone with the first US surgical use of its Remplir™ nerve repair device following FDA clearance, setting the stage for commercial expansion in a $1.6 billion market.

Orthocell’s new study confirms Remplir™ delivers superior nerve regeneration and faster muscle recovery compared to traditional sutures, bolstering its US market rollout plans.

Mesoblast reports positive FDA progress on accelerated approval for Revascor in ischemic heart failure and plans a pivotal trial to extend Ryoncil’s label to adults with graft versus host disease, while its US commercial launch outpaces expectations.

Aroa Biosurgery has reported FY25 results that exceed revenue guidance and deliver a positive normalised EBITDA, setting the stage for ambitious growth and reimbursement expansion in FY26.

Osteopore Limited has drawn down an additional A$500,000 from the first tranche of its redeemable convertible notes, bringing total subscriptions close to the A$5 million tranche limit. The funds will support ongoing operations and future growth initiatives.

Osteopore Limited has increased its capital raise by drawing down an additional A$500,000 on its Tranche 1 redeemable convertible notes, bringing total subscriptions to A$3.5 million. The funds will support ongoing operations and future growth initiatives.

Orthocell has secured regulatory approval to sell its nerve repair product Remplir™ in Hong Kong well ahead of schedule, expanding its footprint across key global markets. This milestone complements recent clearances in the US, Canada, and Asia, positioning the company for significant growth in a multi-billion-dollar market.

Orthocell has rapidly expanded its US distributor network for Remplir™, surpassing its target ahead of schedule and positioning itself for imminent sales in the $1.6 billion nerve repair market.