Osteopore wraps cleft-lip trial recruitment, 5 patients enrolled

Osteopore (ASX:OSX) has finished recruiting all five patients for a clinical trial testing 3D printed implants in children with unilateral cleft lip. The implants go into the paranasal area – the nose and upper jaw – and are designed to replace the current standard of care, which involves harvesting bone from the patient's own hip.

The trial is a single-arm feasibility study run with Queensland Children's Hospital. Dr Yun Phua is the lead investigator. Patients will be followed for 12 months after surgery. The study follows an earlier Osteopore trial for temporal hollowing, announced in May.

Osteopore's implants are made from a bioresorbable composite – polycaprolactone-tricalciumphosphate – that degrades as the body regenerates bone. Each implant is printed from the patient's CT scan data, using the company's Patient Specific Implant workflow already in use at QCH.

The hip-graft approach has poor long-term retention and unpredictable results for nasal shape, according to the company. Osteopore's scaffold is meant to give a structurally accurate, reproducible alternative that supports bone regeneration without adding surgical time. Outcomes are being measured with the validated Cleft-Q patient-reported tool.

Cleft lip and palate affects roughly one in 1,000 births globally. The global repair market was valued at about US$1.2 billion in 2024 and is forecast to reach US$1.9 billion by 2033, according to market estimates cited by the company. Growth is tied to rising surgical volumes and adoption of advanced biomaterials.

OSX shares rose 12.5% to 0.5¢ on the news. Market cap is about A$41,000.