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- Recruitment of all five patients for study completed
- Clinical trial for paranasal augmentation in paediatric patients with rare cleft lip
- Cleft lip and palate impacts approximately one in 1,000 births globally
- Global cleft lip and palate repair market valued at approximately US$1.2b
Osteopore (ASX:OSX) has completed recruitment of all five patients required for the clinical trial of 3D printed paranasal augmentation for patients with unilateral (one-sided) cleft lip.
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Cleft lip and palate effects approximately one in 1,000 births globally, making it one of the most prevalent congenital conditions worldwide.
Patients typically undergo multiple reconstructive procedures throughout childhood and adolescence.
The global cleft lip and palate repair market was valued at approximately US$1.2 billion in 2024 and is forecast to reach US$1.9 billion by 2033, growing at a CAGR of 5.5%. Growth is being driven by rising surgical volumes, increasing awareness of treatment options, and the adoption of advanced biomaterials and surgical techniques.
Osteopore and Queensland Children’s Hospital (QCH) are undertaking a clinical trial for paranasal augmentation in paediatric patients with unilateral (one-sided) cleft lip – which is the augmentation of the nose and surrounding upper jaw structure.
The single-arm feasibility trialn will involve five patients, with follow-up to continue for 12 months after surgery.
The trial, led by Dr Yun Phua, follows a first study for the treatment of temporal hollowing, announced in May 2025.
The study utilises Osteopore’s medical-grade polycaprolactone-tricalciumphosphate (mPCL- TCP) scaffolds, manufactured using 3D printing to produce patient-specific implants precisely matched to each patient’s anatomy.
The scaffolds are 3D printed from a bioresorbable composite (PCL-TCP) that gradually degrades as the body regenerates bone, mimicking the mechanical properties of trabecular bone throughout the healing process.
Implants are designed using each patient’s CT imaging data and manufactured under Osteopore’s established Patient Specific Implant (PSI) workflow, already in clinical use at QCH.
The current standard of care for this condition — cancellous bone grafting harvested from the hip — is associated with poor long-term graft retention and unpredictable outcomes for nasal form.
Osteopore’s scaffold is designed to replace this graft entirely, providing a structurally accurate, reproducible alternative that supports bone regeneration and nasal base support without adding surgical time. This represents a meaningful clinical advancement over existing practice.
By delivering a more predictable and durable outcome, this technology has the potential to reduce revision surgeries, improve facial symmetry, and meaningfully enhance quality of life for patients — outcomes being measured using the validated Cleft-Q patient-reported outcome tool.
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