Osteopore Breaks Revenue Records and Gains EU Approval for Custom Implants
Osteopore Limited has posted a record AUD 835K revenue in Q2 CY25, driven by strong APAC sales and new European market access following EU MDR clearance. The company also advances clinical trials and refreshes key distribution channels.
- Record quarterly revenue of AUD 835K, up 15% QoQ and 11% YoY
- Secured EU MDR clearance for custom orthopaedic and cranial implants
- New clinical studies launched in Australia for skull and jawbone reconstruction
- Distribution channels refreshed in Thailand and the U.S. to boost growth
- Cash balance of AUD 1.774 million with convertible notes raising AUD 2 million
Strong Revenue Growth Signals Momentum
Osteopore Limited (ASX, OSX) has delivered a standout performance in the second quarter of calendar year 2025, posting record revenue of AUD 835,000. This represents a 15% increase from the previous quarter and an 11% rise compared to the same period last year. The growth is largely attributed to robust product adoption across the Asia-Pacific region, which accounts for over 90% of the company's revenue, with craniofacial and aesthetic surgery units leading the charge.
Partnerships have played a pivotal role in this success. Notably, Zimmer Biomet’s product sales surged by 26% in the first half of 2025 compared to the latter half of 2024, tripling sales over the previous 12 months. Early orthopaedic product traction in Singapore, facilitated through a partnership with DKSH, also points to promising developments in new markets.
EU MDR Clearance Opens European Market
A significant milestone was achieved in April 2025 when Osteopore secured European Medical Device Regulation (EU MDR) clearance for its custom orthopaedic and cranial implants. This regulatory greenlight not only validates the company’s cutting-edge regenerative implant technology but also unlocks access to the lucrative European market. With the European orthopaedic and cranial implant markets projected to grow steadily over the coming years, Osteopore is well positioned to capitalize on these expanding opportunities.
Advancing Clinical Innovation in Australia
Osteopore is also advancing its clinical footprint through partnerships with Queensland Children’s Hospital and Princess Alexandra Hospital. These collaborations have launched clinical studies focused on temporal hollowing augmentation in pediatric patients and mandible reconstruction in adults, respectively. These trials, involving 3D-printed patient-specific scaffolds, aim to demonstrate the safety, feasibility, and efficacy of Osteopore’s regenerative implants, potentially paving the way for broader clinical adoption.
Strategic Distribution Refresh and Financial Health
To support sustained growth, Osteopore has refreshed its distribution channels in Thailand and the United States, aiming to enhance customer support and market penetration. Financially, the company ended the quarter with a cash balance of approximately AUD 1.774 million and reduced its operating cash outflows to AUD 655,000, reflecting improved cost management. Additionally, Osteopore raised AUD 2 million through the issuance of 4% redeemable convertible notes, bolstering its funding runway to cover over 27 quarters of operations.
Osteopore’s engagement with professional societies and educational institutions, including seminars and conferences across Asia, further underscores its commitment to innovation and market education, enhancing its profile among surgeons and healthcare providers.
Bottom Line?
With regulatory approvals and clinical trials advancing, Osteopore is poised for growth; but investors will watch closely for clinical outcomes and European market traction.
Questions in the middle?
- How will the outcomes of ongoing clinical trials impact Osteopore’s product adoption and regulatory approvals?
- What is the expected timeline and revenue impact from expanded sales in the European market post-EU MDR clearance?
- How will the refreshed distribution channels in Thailand and the U.S. translate into market share gains and revenue growth?
