DiagnosTear Secures Exclusive Global Rights to CLARIFY Eye Imaging Platform for Needle-Free Blood Diagnostics

DiagnosTear has signed a definitive exclusive global license agreement with Sheba Impact and Ramot for the CLARIFY eye-imaging platform. The technology uses optical spectral imaging of the scleral vasculature combined with AI to provide non‑invasive blood analysis (red cells, hemoglobin, white cells) without a needle. The license carries a royalty of 3% on net sales up to $20M and 4% above $20M, with sublicensing revenue splits of 15% pre‑regulatory approval and 12% post. DiagnosTear will lead all clinical validation, regulatory, and commercialization efforts. The announcement converts the non‑binding term sheet signed on 17‑Dec‑2025 into a binding agreement.

Prior news over the past 18 months shows a steady progression of commercial and clinical initiatives around the core TeaRx dry‑eye diagnostic (CE‑IVD approved) and the Red Eye multi‑biomarker test (FDA‑bound). Collaborations were established in India (Renovate Biologicals, LV Prasad Eye Institute) and the UK (Hanson Medical), while a French CRO (AlyaTec) is executing a clinical study to validate tear‑IgE as a biomarker for allergic conjunctivitis. The company raised $925,000 in a non‑brokered private placement in November 2025 (units at $0.50 with $1.00 warrants) and listed on the Frankfurt Stock Exchange in October 2025. The most recent news extends the portfolio from ocular surface diagnostics into systemic blood diagnostics, a far larger addressable market.

The conversion of the CLARIFY term sheet into a definitive agreement removes a significant uncertainty. While the market had already priced in high expectations when the non‑binding term sheet was announced (stock surged to $0.86 in December 2025), the subsequent 65% decline to $0.30 reflects skepticism about execution, timelines, and funding. Securing exclusive global rights is a tangible step, but it does not alter the fact that CLARIFY remains an early‑stage technology with no clinical validation, no regulatory clearance, and no revenue. The royalty obligations (3‑4%) are reasonable, but the company must fund the entire development program, which will require substantial additional capital. The news alone is unlikely to immediately reverse the extended downtrend, though it may provide a short‑term sentiment lift. It is genuinely new and positive, but not a “game changer” until there is evidence of clinical de‑risking or a strategic funding partner. Thus, I assess it as Material – Positive.

DiagnosTear Technologies Inc. is a point‑of‑care diagnostics company focusing on ophthalmic and systemic conditions via tear‑fluid and ocular‑surface analysis. The flagship product is TeaRx, a CE‑IVD approved rapid test for dry‑eye disease. A multi‑biomarker version (TeaRx Red Eye) can differentiate adenoviral, herpetic, and allergic conjunctivitis and is undergoing clinical validation for FDA submission. The newly licensed CLARIFY platform extends the franchise from ocular surface to systemic blood diagnostics, aiming to replace needle‑based blood draws in selected clinical scenarios.