Osteopore Ltd Implants First Two Patients in QCH Cleft Lip Trial
Osteopore implants first two patients in Queensland Children’s Hospital cleft lip trial
Osteopore Limited (ASX: OSX) has confirmed that the first two of five paediatric patients have successfully received their implants in the cleft lip augmentation clinical trial at the Queensland Children’s Hospital (QCH).
The Australian-Singaporean regenerative medicine company, a global leader in 3D-printed biomimetic and bioresorbable implants, marked the development on 29 June 2026.
The milestone builds on two recent steps in the programme: the trial launch on 2 June 2026 and the completion of all five patient recruitments on 26 June 2026.
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Inside the QCH cleft lip trial
The study at Queensland Children’s Hospital is structured to assess the feasibility of using Osteopore’s technology in a paediatric setting. The key parameters are as follows:
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Single-arm feasibility trial
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Up to 5 paediatric patients with unilateral (one-sided) cleft lip, with recruitment now complete
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Procedure focused on paranasal augmentation, the augmentation of the nose and surrounding upper jaw structure
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12-month patient follow-up after surgery
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Recruitment was expected by end of 2026, but was completed ahead of schedule on 26 June 2026
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Led by Dr. Yun Phua, a Plastic and Reconstructive Surgeon based at QCH and Mater Hospital
This is the second paediatric study led by Dr. Phua using Osteopore technology. The first, announced on 23 May 2025, focused on the treatment of temporal hollowing, signalling a deepening clinical relationship between the surgeon and the Company.
Why bioresorbable scaffolds matter for cleft treatment
Osteopore’s patented technology fabricates micro-structured scaffolds for bone regeneration through 3D printing and bioresorbable material. The scaffolds are manufactured using a polymer that naturally dissolves over time, leaving only natural and healthy bone tissue.
According to the Company, this approach significantly reduces the post-surgery complications commonly associated with permanent bone implants. The technology is designed to enable natural bone healing across multiple therapeutic areas.
From the announcement (paraphrased, not a director quote)
Osteopore’s patent-protected scaffolds use a polymer that naturally dissolves over time to only allow natural and healthy bone tissue to form, reducing complications linked to permanent implants.
This is clinically relevant for cleft patients. Cleft lip and palate affects approximately 1 in 1,000 births globally, and patients typically undergo multiple reconstructive procedures throughout childhood and adolescence. A regenerative approach that resorbs over time is well-suited to growing paediatric anatomy.
The market opportunity behind the milestone
The trial is positioned within a sizeable and growing congenital-condition market. Cleft lip and palate is one of the most prevalent congenital conditions worldwide, supporting a global repair market valued in the billions.
| Metric | Figure |
|---|---|
| Cleft lip & palate prevalence | ~1 in 1,000 births globally |
| Market value (2024) | ~USD 1.2b (~AUD 1.7b) |
| Forecast value (2033) | ~USD 1.9b (~AUD 2.7b) |
| CAGR | 5.5% |
The global cleft lip and palate repair market was valued at approximately USD 1.2b (~AUD 1.7b) in 2024 and is forecast to reach USD 1.9b (~AUD 2.7b) by 2033, growing at a compound annual growth rate (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. For investors, the trial represents Osteopore building clinical validation in a large, growing market.
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What comes next for Osteopore
With the first two implantations complete and recruitment closed, the trial moves into its next phase. The near-term roadmap includes:
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Implantation of the remaining three recruited patients
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A 12-month follow-up period per patient to assess outcomes
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Feasibility data to inform future clinical and commercial pathways
Each completed paediatric study deepens Osteopore’s clinical evidence base and strengthens its surgeon relationships across multiple therapeutic areas. The QCH trial adds a second paediatric study with Dr. Phua, extending the Company’s clinical footprint in regenerative bone treatment.
Osteopore’s neurosurgery approval in Thailand at Thammasat University Hospital, secured just days before the QCH implantations were confirmed, illustrates how the Company is simultaneously building clinical validation across multiple therapeutic areas and geographies.
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