Cellshine has been selected for the Bio-Innovation Technology Regulatory Support Platform Program operated by the Osong Medical Innovation Foundation (K-BIO).
The project covers regulatory support for two product categories: an imaging device for observing conjunctival goblet cells involved in the mucin layer for dry eye disease diagnosis, and a diagnostic pharmaceutical agent for cell staining. The program runs through December 2027.
Through this initiative, Cellshine will systematically build its regulatory strategy for both the GobLens imaging device and its dedicated fluorescent contrast agent, proactively addressing technical and regulatory risks in the approval process.