Orthocell Limited (ASX: OCC)
Orthocell Limited (ASX: OCC) reported a strong financial performance for the December 2024 quarter, achieving a record revenue of $2.21 million, a 9% increase from the previous quarter and a 46% rise compared to the same period in 2023. This marks the third consecutive quarter of record-breaking sales, demonstrating the growing market acceptance and success of its products, Striate+™ and Remplir™. The company’s continued sales growth is attributed to the positive clinical performance of its products, which have gained traction with both new and existing surgeons. Looking ahead, Orthocell expects further revenue expansion, with multiple new markets pending approval, which will unlock additional growth opportunities.
The global expansion of Remplir™ has also made significant strides, notably with the receipt of regulatory approval in Singapore, a critical gateway to ASEAN markets. Orthocell appointed Device Technologies Asia as the exclusive distributor in Singapore, where early sales were achieved ahead of the planned launch in Q1 2025. Additionally, the company submitted its US FDA 510(k) regulatory application for Remplir™, aiming for market clearance in the U.S. by late March or early April 2025. This is a pivotal step towards entering the $1.6 billion U.S. nerve repair market, and the company is preparing for a robust commercial launch with the addition of key U.S.-based executives to lead sales and marketing efforts.
Orthocell has positioned itself strongly for further expansion with a cash balance of approximately A$31 million at the end of the quarter, ensuring the company is well-funded for its upcoming initiatives. In 2025, Orthocell plans to accelerate its global market reach with submissions to additional key markets, including Canada, the UK, the European Union, Brazil, and Thailand. The company aims to target a 20% market share of the $3.2 billion global nerve repair market. With the growing international presence of its products and a solid financial position, Orthocell is well on track to increase its revenue and continue its global expansion strategy.
Mesoblast Limited (ASX: MSB)
Mesoblast Limited (ASX: MSB) successfully raised A$260 million (US$160 million) through a private placement, primarily targeting existing shareholders in the U.S., UK, and Australia. This capital infusion strategically strengthens the company’s financial position as it gears up for the U.S. commercial launch of Ryoncil® (remestemcel-L), an FDA-approved mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children. This marks a significant milestone as Ryoncil® is the first and only MSC therapy approved by the FDA for any indication, creating a substantial first-mover advantage in the space.
Beyond commercialization efforts, the proceeds will accelerate Mesoblast’s second Phase 3 clinical trial for inflammatory chronic low back pain (CLBP), a high-prevalence condition with significant unmet need. The trial is currently enrolling patients and, if successful, could position Mesoblast as a key player in the regenerative treatment landscape for chronic pain. Additionally, the funds will be used to expand manufacturing capacity in anticipation of increased demand and to support working capital and corporate expenses. Further strengthening its capital markets profile, Mesoblast was recently added to the Nasdaq Biotechnology Index (NBI), increasing its visibility among institutional biotech investors and improving liquidity in its U.S.-listed securities.
The company is also making notable progress in its regenerative medicine pipeline. In December 2024, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Revascor® (rexlemestrocel-L) for the treatment of hypoplastic left heart syndrome (HLHS), a life-threatening congenital heart defect. The RMAT designation—coupled with Rare Pediatric Disease (RPDD) and Orphan-Drug (ODD) designations—provides a regulatory advantage, including priority review and rolling submissions for a Biologics License Application (BLA). Early clinical data suggest Revascor® significantly improves heart function and surgical outcomes, reinforcing its potential as a breakthrough therapy in pediatric cardiology. With multiple late-stage assets, growing regulatory support, and a strengthened balance sheet, Mesoblast is well-positioned for near-term commercialization and long-term value creation in the regenerative medicine sector.
Source: Company’s Report
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