Tissue Repair’s Global Expansion Hinges on Regulatory Approvals and Production Scale-Up

Strategic Distribution Partnerships

Tissue Repair Limited (ASX – TRP) has taken a significant step forward in its commercial journey by appointing Advanced Cosmeceuticals Pty Ltd as the exclusive distributor for its flagship TR Pro+® product line across Australia and New Zealand. This partnership leverages Advanced Cosmeceuticals’ extensive network of over 2,500 clinics, pharmacies, and online retailers, including major chains such as Priceline and Chemist Warehouse. The move substantially expands Tissue Repair’s footprint from a modest 200-clinic pilot to a nationwide rollout targeting dermatologists, plastic surgeons, and aesthetic clinics.

Simultaneously, Tissue Repair has inked its first international distribution agreement with Thailand’s Amellie and Proud Co., Ltd, a leader in the premium aesthetics market. This marks the company’s initial foray into Southeast Asia, a region known for its dynamic growth in medical aesthetics, and sets the stage for further global expansion.

From Development to Revenue Generation

These distribution deals signal Tissue Repair’s transition from a clinical-stage biotech focused on innovation to a revenue-generating enterprise. The company plans a formal Australia-wide launch of TR Pro+® in February 2026, with a soft launch under consideration. TR Pro+® is positioned as a topical treatment to accelerate skin healing and improve recovery following cosmetic and medical procedures, supported by compelling clinical evidence and regulatory approvals including TGA-listed medicine status.

CEO Tony Charara emphasised the strategic importance of these partnerships, highlighting their role in fast-tracking commercialisation and enabling rapid market access. The collaboration with Advanced Cosmeceuticals, backed by Wesfarmers’ ownership links, offers a robust platform to reach both clinical and retail customers.

Manufacturing Scale-Up and Regulatory Progress

To meet anticipated demand, Tissue Repair is expanding its manufacturing capabilities with a preferred partner, aiming for commercial-scale production by late 2026. This scale-up will not only support supply but also generate critical data to underpin future regulatory filings, including an Investigational New Drug (IND) application with the FDA.

On the regulatory front, the company is advancing pathways for the US FDA 510(k) clearance and CE Mark certification in Europe and Asia. These approvals are crucial for accessing large international markets and underpin Tissue Repair’s global ambitions. The company retains global rights to its medical line of TR Pro+®, targeting acute and chronic wound care, with plans for dedicated launches in healthcare settings.

Outlook and Market Potential

The strong demand observed during the Australian pilot, which led to temporary stock shortages, underscores the market readiness and potential for TR Pro+®. With a comprehensive distribution strategy, manufacturing scale-up, and regulatory momentum, Tissue Repair is well positioned to capitalize on growing global demand for advanced wound healing and aesthetic recovery products.

Looking ahead, the company’s focus on innovation continues with the development of a new rejuvenating serum powered by its proprietary Glucoprime® technology, expected to launch through Advanced Cosmeceuticals’ platform. This product pipeline diversification could further enhance Tissue Repair’s market presence and revenue streams.