Tissue Repair Grows Revenue 27% to $3.22M, Posts $4.24M Loss
Tissue Repair Ltd reported a 27.3% revenue increase to $3.22 million for FY25, driven by new distribution deals and regulatory progress, while continuing to invest heavily in clinical trials and manufacturing scale-up, resulting in a $4.24 million loss.
- 27.3% revenue growth to $3.22 million
- Loss after tax of $4.24 million, slightly higher than prior year
- Multi-year distribution agreements secured in Australia, New Zealand, and Thailand
- Phase 3 clinical trials for TR987® progressing despite recruitment challenges
- Expansion of manufacturing capacity for proprietary Glucoprime® API underway
Financial Performance and Market Expansion
Tissue Repair Ltd has reported a solid 27.3% increase in revenue for the year ended 30 June 2025, reaching $3.22 million, largely attributed to the commercialisation of its TR Pro+™ product. Despite this growth, the company recorded a loss after tax of $4.24 million, a modest increase from the previous year's $4.14 million loss, reflecting ongoing investments in research, development, and market expansion.
Key to this revenue growth has been the signing of multi-year distribution agreements with Advanced Cosmeceuticals Pty Ltd for Australia and New Zealand, and with Amellie and Proud Co., Ltd for Thailand. These partnerships open access to over 2,500 clinics, pharmacies, and online retail channels, positioning TR Pro+™ for a national rollout in early 2026 and entry into the Southeast Asian aesthetics market.
Clinical Trials and Regulatory Progress
The company continues to advance its Phase 3 clinical trials for its drug candidate TR987®, targeting chronic wounds such as venous leg ulcers. Recruitment has been slower than anticipated due to increased competition for trial participants in the US market, driven by Medicare's new reimbursement requirements. Tissue Repair is implementing mitigation strategies to accelerate enrolment across 44 selected sites in the US and Australia.
On the regulatory front, Tissue Repair is pursuing FDA 510(k) clearance and CE Mark certification for TR Pro+™, with approvals expected within the next 12 months. These certifications will enable access to major global markets including the US, Europe, Asia, and the Middle East. Additionally, the company has secured TGA listed medicine status in Australia for its medical TR Pro+™ line, preparing for domestic launch targeting pharmacies, aged care, and healthcare providers.
Manufacturing Scale-Up and Intellectual Property
To support anticipated global demand, Tissue Repair has invested over US$1.1 million to expand manufacturing capacity for its proprietary Glucoprime® active pharmaceutical ingredient (API). The company has selected a contract manufacturing organisation (CMO) expected to begin qualification in Q3 2025, marking a critical step toward commercial-scale production.
Intellectual property remains a cornerstone of Tissue Repair’s strategy, with multiple US patents granted covering the manufacture, composition, and use of Glucoprime®. The company is also pursuing patent protection in key international jurisdictions, reinforcing barriers to competition and supporting long-term exclusivity.
Leadership and Governance
The year saw significant board changes with the appointment of Alistair McKeough as Non-Executive Chair and Patryk Kania as Non-Executive Director in October 2024, while three directors resigned. Executive remuneration remains aligned with company performance, with incentives tied to clinical trial milestones and sales growth. The company maintains a strong cash position of $12.3 million as of June 2025, providing runway for continued development and commercialisation efforts.
Outlook and Strategic Focus
Tissue Repair is focused on scaling its global footprint through strategic partnerships and regulatory approvals, while advancing its Phase 3 trials and expanding manufacturing capabilities. The dual-market strategy for TR Pro+™, targeting both aesthetic and medical wound care channels, positions the company to capture significant unmet needs in chronic and acute wound treatment markets worldwide.
Bottom Line?
Tissue Repair’s strategic partnerships and regulatory momentum set the stage for potential global expansion, but clinical and manufacturing hurdles remain key watchpoints.
Questions in the middle?
- How will Tissue Repair overcome recruitment challenges in its Phase 3 clinical trials to meet regulatory timelines?
- What is the timeline and likelihood for FDA and CE Mark approvals for TR Pro+™?
- Can the company successfully scale manufacturing to meet anticipated global demand without compromising quality?
