Main risks
The main challenge for MgShell lies in achieving the necessary validations, certifications, and approvals, which are standard processes for medical devices and pharmaceutical products. Although the risk of device rejection is low due to the promising results obtained in-vivo studies and the clinical use of magnesium in other applications, such as cardiovascular stents, the key challenge is the industrialization of the technology. This includes drug reformulation, loading into the device cores, and final assembly.