Latest Regenerative Medicine News

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.

Mesoblast has commercially launched Ryoncil in the US for pediatric acute GVHD, backed by a strong cash position and advancing multiple cell therapy programs.

Orthocell has secured Health Canada approval for its nerve repair product Remplir™, adding the US$75 million Canadian market and expanding its total addressable market to US$1.8 billion. The company plans to appoint local distributors and expects first sales in H2 2025.

Aroa Biosurgery reports a second consecutive quarter of positive operating cash flow and record sales for its Myriad product line, while maintaining full-year FY25 revenue and EBITDA guidance.