Spermosens (SPERM) Status update summary

Product development and regulatory status

• Product has reached commercial specification, now faster, simpler, and more robust.

• Technical development is nearly complete; clinical relevance of the new version must be verified.

• Regulatory path follows FDA, EMA, and other bodies, requiring performance documentation and clinical validation.

• Early launch possible in CLIA-certified labs before full regulatory approval.

• Clinics are already testing the product, with quick installation possible.

Risk assessment and clinical validation

• Main risk is reproducing strong clinical results with the new product version.

• Regulatory risks are considered minimal, with main concern being potential delays.

• Commercial risk centers on market size and adoption.

• Clinical proof of concept from last year has significantly de-risked the project.

Commercial strategy and partnerships

• No commercial agreements signed yet due to need for clinical evidence and product improvements.

• Four MOUs signed, with two active; about 10-15 ongoing dialogues with potential partners.

• Interest in Japan remains high, with ongoing discussions and a signed MOU.

• Targeting exclusive deals by territory or segment; ambition to sign a deal in H2 2026.

• Product is unique with no direct alternatives, confirmed by partner feedback.