INTRA-KER Receives Ministry of Health Approval to Initiate Clinical Study of Hybrid Artificial Cornea

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For Immediate Release – Forlì, October 17, 2025

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INTRA-KER Srl, the Italian medtech company developing a next-generation hybrid artificial cornea, today announced that it has received all necessary approvals from the Italian Ministry of Health to begin its first clinical trial this November.

 

The study marks a major milestone for INTRA-KER’s mission to transform treatment for millions of patients worldwide suffering from corneal blindness. Unlike traditional corneal transplants, which rely on scarce donor tissue and face high risks of rejection, the INTRA-KER device combines a hybrid optical device with a patented biological wrap that integrates with host tissue, ensuring stability, long shelf life, and reduced complications.

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“Achieving Ministry of Health approval is a crucial step for INTRA-KER and validates the years of research that have gone into this innovation,” said Prof. Massimo Busin, founder of INTRA-KER. “We are eager to begin treating patients and to demonstrate the safety and efficacy of this device in a clinical setting.”

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The upcoming clinical study will enroll 30 patients, who have already been identified and are awaiting treatment at leading ophthalmology centers. Patient recruitment is set to begin in November 2025, with initial results expected in the following 6-12 months.

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This milestone follows INTRA-KER’s recent announcement of a strategic collaboration with XPANCEO, a deep tech company pioneering optical and electronic integration. Together, the two companies aim to evolve the hybrid cornea into a future “smart cornea” capable of restoring and even enhancing vision.

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About INTRA-KER

Founded by Prof. Massimo Busin, INTRA-KER is a clinical-stage medtech startup based in Forlì, Italy. The company’s patented hybrid artificial cornea is designed to address the global shortage of donor corneas and overcome the limitations of current keratoprostheses. INTRA-KER is now advancing through human clinical studies and preparing for broader international trials.