The third quarter has been characterized by high intensity and continued progress for iCoat Medical. During the period we have continued to make important progress in the development of our product candidate TUM012 with the purpose of protecting organs in connection to transplantation. All organs that are transplanted run the risk of Ischemia Reperfusion Injury since cells suffer from a lack of oxygen and thereby the immune system is activated and it attacks and damages these cells. TUM012 protects ischemic cells from the immune system and thereby reduces the risk of inflammation and organ rejection. Its use improves patient outcome, increases availability of marginalized organs for transplantation and reduces societal costs associated with kidney failure.
Our ongoing First-in-Human study (phase I) ATMIRe reported its first interims data, showing that none of the patients had any negative side effects from our product TUM012 and after the period more than 50 percent of patients that will be included in the study had been treated without any negative side effects. While ATMIRe progresses, the business has already begun planning for a coming phase II study for use of TUM012 in kidney transplants and also begun preparing pre-clinical studies with a focus on the use of TUM012 in heart transplant and open heart surgery. This broadened focus is the result of our belief that TUM012 has great potential to create medical benefits in connection to other procedures as well, not just kidney tranplants, in which Ischemia Reperfusion Injury is a problem.
The business climate remains challenging for many companies and this is also true for iCoat Medical. Rising inflation and a more troublesome geopolitical development has to some extent meant higher purchasing prices for iCoat Medical, it has simply become a bit more expensive to carry out our research and development. However, iCoat Medical runs a focused and cost efficient operation thanks to our academic collaborations and close relations to Skåne’s University Hospital in Malmö.
iCoat Medical continues to run a solid business, despite recent economical and geopolitical developments, and we continue to make progress according to our plans. Initial results from the clinical study ATMIRe looks promising and we expect to complete the study in the first half-year of 2023. At the same time, work continues to evaluate TUM012 and TUM020 also for other medical conditions and organ transplants.
I look forward to continuously updating you on the company’s development and clinical results going forward.
CEO, iCoat Medical AB