Tetratherix (ASX:TTX) has announced that its joint venture, Tutelix, has received approval from the Human Research Ethics Committee in Australia to start an international pivotal clinical trial for its hydrogel spacer.
The study is planned to enrol about 240 patients to support both TGA and FDA 510(k) submissions. It is structured so that roughly half of the patients will be recruited in Australia and half in the United States, with Australian enrolment expected to begin in the first quarter of the financial year 2027 and US enrolment to follow, subject to IDE approval.
The company also reported the completion of the Tutela pilot study, with all 15 patients implanted across multiple Australian sites and no product-related adverse events recorded at any follow-up visit. Early results from a six-month follow-up in a third of those patients demonstrate that the Tutelix spacer maintains structural stability, does not migrate, is visible on ultrasound, and sustains separation between target tissue and nearby organs to optimise radiation delivery.
The company is exploring a gynaecological indication where no spacer is currently approved. Dr Ali Fathi, CTO of Tetratherix, said, “The positive six-month follow-up data confirms an exciting opportunity beyond the prostate program. Tutelix maintaining its structure and holding space under sustained anatomical pressure gives us a technical basis to pursue a gynaecological indication where no commercially approved product has existed.”
Radiation treatment for cervical, uterine and vaginal cancers can be limited by nearby organs, increasing toxicity and reducing effective dose delivery. More than 20,000 women per year receive radiotherapy courses longer than 75 days, a threshold associated in published data with a drop in three-year survival from about 88 per cent to about 42 per cent. By creating protective spacing that may enable more effective dosing within the critical window and reduce toxicity, Tutelix could address a currently unmet clinical need and influence patient outcomes.
