hemotune AG, a pioneering Swiss medtech company, today announced the publication of a peer-reviewed investigation confirming the safety and feasibility of its HemoSystem, a magnetic separation-based blood purification platform built on the company’s proprietary HemoBeads technology. The scientific publication, “Safety and Feasibility of Magnetic Separation-Based Blood Purification,” appears in Advanced NanoBiomed Research and was conducted under Good Laboratory Practice (GLP) in collaboration with the University Hospital Bern, EMPA, ETH Zurich, NAMSA, and Syngene International.
The study represents a comprehensive biological safety evaluation of a complete magnetic separation-based blood purification system, addressing the removal efficiency of the magnetic nanoparticles and the biocompatibility of the integrated device system.
Preclinical investigations according to ISO 10993 assessed acute and chronic toxicity as well as biodistribution up to 52 weeks after exposure. Nanoparticles did not cross the blood-brain barrier and were gradually cleared from the body. In vivo preclinical treatment simulations showed no relevant adverse events. Magnetic separation of the HemoBeads from blood was ≥ 99.9%.
Carlos A. Mora, CTO and co-founder of hemotune, and first author of the publication, comments: “This publication is an important milestone for hemotune. It provides robust, GLP-compliant evidence that our approach to precision blood purification based on our innovative technology is safe and ready to move into the clinic. Every step of this program, from nanoparticle design to the in vivo treatment simulation, was built to withstand the level of scrutiny required before treating patients.”
Prof. Dr. Joerg C. Schefold, Director Intensive Care Medicine of the University Hospital Bern and co-author of the publication, remarks: “Rigorous preclinical testing is the scientific prerequisite before moving on to investigate treatment effects in patients. The publication thus marks a corner stone towards bringing the novel precision-medicine guided blood purification approach to patients with septic shock . The device should now be tested in a large-scale clinical trial.”
The full publication is available open access: Publication in “Advanced NanoBiomed Research”