The mediGLUE project, funded by the German Federal Ministry of Education and Research under grant number 161B0393, ran from 1 October 2018 to 31 March 2023 and was led by Purenum GmbH with Dr. Ingo Grunwald as project manager. The consortium built on the earlier mediNiK 1.0 effort and added a second‑generation mediNiK 2.0 system and a new bone‑glue line called mediArK. The primary scientific aim was to create a water‑polymerising hydrogel that can be applied through the working channel of a ureteroscope to encapsulate tiny kidney‑stone fragments that normally remain in the kidney after lithotripsy. The gel is formed by mixing two pre‑polymer components that react in the presence of the irrigation fluid, which contains divalent ions. Once the gel hardens, the encapsulated fragments become large enough to be grasped and removed with standard retrieval baskets, eliminating the need for new instruments or procedural changes. This approach directly addresses the clinical problem that fragments smaller than 1–2 mm are rarely cleared spontaneously, leading to recurrent stone formation and repeated interventions. The mediNiK system therefore promises higher stone‑free rates without adding operative time or complexity.

Technical milestones achieved during the project include up‑scaling the manufacturing process to a reproducible production line, validating a sterilisation protocol that preserves viscosity and curing kinetics, and completing a full biocompatibility assessment in accordance with DIN EN ISO 10933. The team also defined the complete intra‑operative workflow, specifying component dosages, application timing, and required accessories for surgeons. A feasibility study in humans is planned to confirm the system’s safety and efficacy in a clinical setting. In parallel, mediArK was formulated as a single‑component, injectable bone‑glue with enhanced tackiness, targeting fixation of bone fragments in orthopaedic and dental procedures. Pre‑clinical tests on animal tissue and rheological characterisation are underway, with biocompatibility to be verified under DIN EN ISO 10993‑5.

The project’s collaborative framework involved Purenum GmbH, the lead partner, and external scientific collaborators such as Prof. Jeffrey Cadeddu’s group at the Southwestern Medical Center in Dallas, who explored magnetic capture of calcium‑oxalate stones. While Cadeddu’s approach uses peptide‑linked paramagnetic beads, it is limited to small, single‑type stones and lacks the degradable, food‑grade components of mediNiK. Other potential competitors, such as Boston Scientific’s Backstop hydrogel, were evaluated; Backstop’s temperature‑induced polymerisation proved insufficiently robust for fragment containment, and its application in the kidney is not recommended. No commercial product currently matches mediNiK’s combination of in‑situ gelation, fragment encapsulation, and ease of removal.

Beyond the technical achievements, mediGLUE strengthened the German biomedical innovation ecosystem by transferring a novel biomimetic adhesive from laboratory to a commercial start‑up. The project’s outcomes will support Purenum’s future product development, positioning the company as a key player in the European medical‑device market and contributing to the country’s economic competitiveness in high‑tech health care.