Tetratherix Raises $25M, Secures Bio Optix License, Advances FDA Pathway

Strategic Partnership to Disrupt Ophthalmic Market

Tetratherix Limited (ASX – TTX) has entered an exclusive strategic licensing agreement with New York-based Bio Optix Inc., targeting the development and commercialisation of an ophthalmic viscoelastic device (OVD) built on Tetratherix’s proprietary polymer platform. This collaboration aims to challenge the dominance of a few major players in the global OVD market, valued at approximately USD 700 million.

Bio Optix brings deep clinical expertise and commercial experience, being a portfolio company of AdAstral Labs and led by seasoned ophthalmic physicians. The partnership will see Tetratherix become a minority shareholder in Bio Optix, with Bio Optix funding all US FDA regulatory approval activities. Upon commercialisation, Tetratherix will manufacture the products at its Australian ISO13485-certified facilities, with minimum purchase commitments of one million units annually for the first five years.

Regulatory Progress and Clinical Development

In parallel, Tutelix Pty Ltd, a 50% joint venture partner of Tetratherix, completed a pre-submission meeting with the US FDA for its prostate spacer product. The FDA indicated a Class II product classification and outlined the clinical trial requirements, keeping the 510(k) clearance on track for FY28. This regulatory progress is a critical step in advancing the tissue spacing franchise within Tetratherix’s portfolio.

Looking ahead, Tetratherix plans to initiate the first-in-human clinical study for Tutelix in Queensland, Australia, in Q1 FY26. Additional regulatory milestones are targeted for other products under development, including Tegenix and TegeEOS for bone regeneration and TetraDerm for tissue healing, with clinical trials and FDA clearances anticipated in the coming years.

Capital Raise Fuels Growth and Expansion

Tetratherix’s successful ASX listing on 30 June 2025 raised $25 million through the issuance of 8.68 million shares at $2.88 each, valuing the company at approximately $145 million. The capital injection, combined with a strong cash balance of AUD 29.3 million and zero debt, positions the company well to invest in research and development and expand its advanced manufacturing capabilities.

CEO Will Knox highlighted the quarter as pivotal, emphasizing the company’s readiness to accelerate growth and deliver on strategic milestones. The company’s use of funds aligns with its prospectus, focusing on R&D projects across its three core franchises, bone regeneration, tissue spacing, and tissue healing, while maintaining rigorous quality standards and preparing for manufacturing scale-up.

Outlook and Market Potential

Tetratherix’s proprietary Tetramatrix platform underpins a diversified product portfolio addressing significant unmet medical needs. The company’s strategy to co-develop multiple products with leading medical partners aims to bring faster, safer, and more cost-effective treatments to market globally. The Bio Optix partnership and FDA regulatory advancements mark important inflection points that could unlock substantial licensing income and commercial opportunities starting FY26 and beyond.

With clinical trials commencing and regulatory pathways progressing, Tetratherix is poised to transform complex disease treatment paradigms while expanding its footprint in the competitive medical technology sector.