IsoVasc Medical received ISO13485 certification in February 2026 for the importation and distribution of Medical Devices in the Interventional Oncology sector. This internationally recognised standard for quality management systems in the medical device sector represents a significant milestone, demonstrating IsoVasc’s commitment to have a robust quality management system in place, appropriate risk management processes, and regulatory compliance. As Isovasc continues to grow the scope of this certification will be increased in the near term.
What does this mean for IsoVasc Medical?
“This is a significant milestone in our commitment to quality, compliance and continuous improvement”
Michael Leen – CEO
In addition, clinical experience and data relating to the Company’s Isolated Perfusion technique was presented at the European Congress of Interventional Oncology in April 2026 (Basel, Switzerland). This presentation led by Dr Utku Mahir Yildirim (IR) and the team at Biruni University Hospital Istanbul represents the first experience data from the Stop-flow Occlusion Catheter and the Isolated Perfusion Technique within an Interventional Radiology setting, “Preliminary Results of Percutaneous Hypoxic Isolated Abdominal Perfusion (HIAP) for Paclitaxel/Platin Resistant High-Grade Ovarian Cancers”. In total five (5) patients resistant to Paclitaxel/Platinum based Chemotherapy were treated with repeat cycles of Isolated Perfusion every four weeks. According to mRECIST criteria an Objective Response Rate (ORR) of 60% and a Disease Control Rate (DCR) of 80% was achieved.
“Together, these developments highlight significant progress in the Company’s mission to develop technologies facilitating targeted trans-arterial drug delivery, combined with perfusion and filtration techniques, thereby potentially increasing efficacy and quality life of cancer patients.” – Michael Leen