• Successful first in human insertion of the Tutelix hydrogel spacer; progression to stage 2 Tutela clinical study
• Completion of FDA pre-submission for TetraDerm and progression through to Cohort 2 of the clinical trial
• $3.3m funding secured for FY26-27 through the Industry Growth Program

Tetratherix Limited, a biomedical company focused on developing innovative solutions in regenerative medicine and medical device technology, has reported its H1 FY26 results. The company delivered on key strategic priorities, including successful first in human insertion of the Tutelix hydrogel spacer and progression to stage 2 of the Tutela clinical study, completion of FDA pre-submission for TetraDerm and progression through to Cohort 2 of the clinical trial, and securing $3.3 million in funding through the Industry Growth Program for FY26-27. The company also strengthened its strategic alliances, finalizing an exclusive global quality and supply agreement with Henry Schein, Inc. and signing an exclusive strategic licensing agreement with BioOptix, Inc. Tetratherix continues to build high-performing teams, maintaining a zero attrition rate and with 68% of the workforce identifying as female. The company also executed a lease agreement for an additional advanced manufacturing site and new company headquarters, with the fit-out underway for relocation in H2 FY26. Financially, Tetratherix reported a statutory loss of $4.6 million, with a strong cash position of $21.6 million as of 31 December 2025, providing a robust capital structure to support continued investment in R&D and advanced manufacturing.

The company is targeting FDA 510(k) clearance for its Tegenix and TegenEOS bone regeneration products in FY26.

In H2 FY26, Tetratherix will focus on finalizing preclinical studies for Tegenix and TegenEOS, commencing Cohort 3 of the TetraDerm clinical trials, and progressing stage 2 of the Tutela clinical study for the Tutelix hydrogel spacer. The company will also continue to strengthen and expand its strategic alliances, including finalizing a commercial arrangement with an orthopaedic market leader for its bone regeneration franchise and exploring potential for nasal drug delivery applications.