• Successful Series A funding round raises $5 million for Tutelix JV
• Tutelix spacer shows promising results in pilot clinical trial
• Pivotal trial in US and Australia to commence in 2026 for FDA clearance by 2028

Tetratherix Limited (ASX:TTX) is pleased to announce the progression of its prostate spacing clinical trial for its Tutelix product, with promising indications of performance on patients undergoing radiation therapy. The trial has been designed to investigate the ability of Tutelix to be safely injected between the prostate and rectum to create and maintain space around the prostate, which can lower the amount of radiation the rectum receives and reduce the risk of side effects. The results from this human study showed that Tutelix is simple to use, maintains its shape and form, does not migrate from the injection site, and does not cause any safety issues. Following these positive results, Tetratherix is rapidly moving into the international pivotal study in the US and Australia. The company's joint venture (JV) partner, Tutelix Pty Ltd, has successfully completed a Series A funding round from key investors, including a dedicated MedTech venture capital firm and a syndicate of key opinion leaders in the prostate spacer market. This capital raise of approximately $5 million will allow the JV to fast-track the clinical trial and move towards an international pivotal study in Australia and the US. The engagement of the US-based key opinion leaders will also provide immediate in-market presence and strong commercial momentum for rapid US adoption of the product upon FDA approval, which is expected by 2028.

The company is progressing the Tutelix product towards an international pivotal study in the US and Australia, with plans to submit for FDA clearance by 2028.

Tetratherix is well-positioned to capture a significant share of the global prostate spacer market, estimated to be US$1.3 billion, with the Tutelix product offering a clinician-friendly, cost-effective, and easy-to-use solution that can meet the growing demand for efficient prostate cancer radiation therapy.