Latest Regenerative Medicine News

Mesoblast is set to meet the FDA in December to discuss compelling Phase 3 data showing its cell therapy rexlemestrocel-L may significantly reduce opioid use in chronic low back pain patients. This meeting could mark a pivotal step in addressing the US opioid crisis through innovative regenerative medicine.

Cynata Therapeutics is on track to deliver key clinical trial results in mid-2026 while maintaining a solid cash runway supported by an imminent R&D tax rebate and equity facility.

Orthocell has appointed MontsMed as the exclusive distributor for its nerve repair product Remplir™ in Hong Kong, marking a significant step in its Asian commercialisation strategy. This move opens access to the vast Guangdong-Hong Kong-Macao Greater Bay Area, complementing existing operations in Singapore and planned expansion in Thailand.

Cambium Bio has locked in a significant R&D tax rebate and forged three strategic partnerships, underpinning its Phase 3 clinical trials for its lead ophthalmology biologic. The company’s recent capital raise further strengthens its runway as it prepares for pivotal trial milestones.

Tetratherix reports encouraging safety and stability results from its Tutelix hydrogel spacer trial, initiates stage 2 recruitment, and secures a $3.3 million government grant to boost manufacturing capacity and R&D.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

Orthocell has raised $30 million through an institutional placement to accelerate the US commercialisation of its flagship nerve repair product Remplir and expand its regenerative medicine portfolio.

Aroa Biosurgery delivered a robust September quarter with strong cash flow and record sales of its Myriad product, while reaffirming its FY26 revenue and EBITDA guidance. The company also highlighted a promising US Medicare reimbursement proposal for its Symphony product.

Orthocell Limited has reported a record $3 million quarterly revenue, driven by strong sales of its nerve repair product Remplir in Australia and Singapore, while advancing its rollout in the US and Canada ahead of schedule.

Orthocell has reported a record $3 million revenue for the September quarter, driven by strong sales of its nerve repair product Remplir™ in Australia and Singapore, with early US sales and Canadian market entry poised to accelerate growth.

Orthocell’s nerve repair device Remplir is being adopted in Australia for nerve-sparing prostate cancer surgeries, aiming to reduce erectile dysfunction and urinary incontinence post-operation. This development could significantly expand Remplir’s market reach globally.

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.