Tissue Repair Faces Enrollment and Regulatory Challenges Ahead of 2026 Rollout
Tissue Repair Limited reports steady progress in its Phase 3 clinical trials for chronic wound treatment and advances regulatory filings for its TR Pro+® product, while gearing up for a major commercial rollout in early 2026.
- 35 patients randomized across two Phase 3 trials for TR987®
- Partnership with Advanced Cosmeceuticals expands TR Pro+® clinic network
- Regulatory progress includes FDA drug classification and ongoing 510(k) and CE mark submissions
- Cash position of $10.3 million with $1.97 million net operating outflow in the quarter
- Major TR Pro+® production campaign planned for February 2026
Clinical Trial Momentum
Tissue Repair Limited (ASX – TRP) has provided a comprehensive update on its September 2025 quarter activities, highlighting measured but meaningful progress in its Phase 3 clinical trials targeting chronic wounds. The company’s lead candidate, TR987®, is being evaluated across two pivotal studies; BG002 in the US and BG003 spanning the US and Australia. With 46 clinical sites selected, 33 initiated, and 24 activated, patient randomization has begun to pick up pace, reaching approximately 35 patients to date. This acceleration is expected to strengthen as five large institutions come online in the coming quarters.
Regulatory Pathways and Product Development
On the regulatory front, Tissue Repair has secured confirmation from the FDA that TR Pro+® will remain classified as a drug rather than a biologic, streamlining its approval pathway. The company is actively preparing submissions for US 510(k) clearance and CE mark Class I and II device certifications, aiming to facilitate market entry across the US, Europe, and Asia. Stability testing and manufacturing validations continue, underpinning the upcoming major production campaign scheduled for February 2026, which will produce all TR Pro+® tube formats for the first time under TGA approval.
Commercial Expansion and Strategic Partnerships
Commercial efforts are gaining momentum through a newly established partnership with Advanced Cosmeceuticals Pty Ltd, which took effect in mid-September 2025. This alliance is set to leverage AC’s extensive network of over 2,500 clinics, a significant expansion from Tissue Repair’s previous reach of around 400 clinics. While meaningful sales growth is anticipated to commence in early 2026 once all product SKUs are available, the transition marks a strategic shift aimed at accelerating market penetration in the aesthetic and medical procedure segments.
Financial Position and Outlook
Financially, Tissue Repair ended the quarter with a cash balance of $10.3 million, having recorded net operating cash outflows of approximately $1.97 million, primarily driven by research and development expenses. Revenue from TR Pro+® sales rose modestly to $202,000, reflecting early-stage commercial activity. The company remains focused on optimizing manufacturing processes, expanding its product portfolio with next-generation formulations, and advancing regulatory approvals to support broader market access.
Looking Ahead
As Tissue Repair moves into the next quarter, key milestones include accelerating patient enrollment in its Phase 3 trials, completing manufacturing batches to support product launches, and advancing regulatory submissions in multiple jurisdictions. The company’s strategic partnership and product development pipeline position it well for a potentially transformative 2026, though execution risks remain inherent in clinical and regulatory timelines.
Bottom Line?
Tissue Repair’s steady clinical and commercial progress sets the stage for critical milestones in 2026, with patient enrollment and regulatory approvals in focus.
Questions in the middle?
- Will patient enrollment in Phase 3 trials accelerate sufficiently to meet projected timelines?
- How quickly will the partnership with Advanced Cosmeceuticals translate into meaningful sales growth?
- What are the potential regulatory hurdles remaining for US 510(k) and CE mark approvals?
