TR Pro+ Sales Jump 35% as TR987 Phase 3 Trial Enrolment Begins

Phase 3 Trial Progress Despite Challenges

Tissue Repair Limited (ASX:TRP) has marked a significant milestone with the first patient randomisation in its Phase 3 clinical trial for TR987®, a drug candidate targeting chronic wounds. While the trial has faced enrollment headwinds due to severe weather events in the US and FDA-mandated protocol amendments, the company anticipates a ramp-up in patient recruitment as these issues resolve and ethics approvals for the amended protocol are secured.

More than 30 clinical sites across the US and Australia have been qualified, with 18 initiated and 10 activated, underscoring the company’s commitment to advancing this critical stage of development. The trial’s progress is pivotal for TRP’s strategy to bring a novel wound healing therapy to market.

Robust Growth in TR Pro+® Sales

Complementing its clinical efforts, Tissue Repair’s commercial product TR Pro+® has demonstrated strong momentum. Quarterly sales increased by 35% in Q4 2024, with monthly sales peaking at 45,000 units in December. The product has gained traction in over 270 clinics, reflecting growing market acceptance and demand.

Responding to customer feedback, the company successfully tested larger 30g tubes of TR Pro+®, which sold rapidly at a premium price point, validating the market’s appetite for expanded product formats. This commercial success is expected to underpin future revenue growth and support ongoing R&D activities.

Manufacturing and Regulatory Advances

To support anticipated global distribution, Tissue Repair has committed an additional US$1 million to expand manufacturing capacity of its proprietary Glucoprime® API. This investment aims to secure sufficient inventory for both domestic and international partners, while generating critical analytical data to bolster regulatory submissions.

In parallel, the company is pursuing a US 510(k) device classification for TR Pro+®, which could accelerate market entry and leverage existing reimbursement pathways, potentially enhancing unit economics significantly. This dual regulatory approach, drug approval for TR987® and device clearance for TR Pro+®, positions Tissue Repair to capitalize on multiple commercial channels.

Distribution Partnerships and Market Expansion

Tissue Repair is in advanced negotiations with a distributor for the aesthetics channel in Australia and New Zealand, aiming to broaden TR Pro+®’s reach. Discussions are also underway for a second distributor focused on medical applications, including acute wounds, which could facilitate entry into pharmacy channels.

Having demonstrated a compelling business case locally, the company is actively engaging potential overseas distributors to extend its footprint beyond Australasia, signaling an ambitious growth trajectory.

Financial Position and Outlook

Despite net operating cash outflows of approximately $2.15 million in the December quarter, primarily driven by clinical development and commercialisation expenses, Tissue Repair maintains a healthy cash balance of $14.4 million. The company expects favourable R&D tax incentive refunds to further extend its cash runway, providing financial flexibility to execute its strategic objectives.

Payments to related parties, including director fees, remain within normal commercial terms and reflect prudent governance. Overall, the company’s financial discipline supports continued investment in both clinical and commercial initiatives.