Iss A/S (Otc) ((ISFFF)) announced an update on their ongoing clinical study.
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Study Overview: The clinical study titled ‘Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis’ aims to evaluate the safety and effectiveness of the NucleoCapture device in reducing circulating cell-free DNA and Neutrophil Extracellular Traps in patients with sepsis. This study is significant as it targets a critical condition that can lead to severe complications, including respiratory failure.
Intervention/Treatment: The intervention being tested is the NucleoCapture device, a selective DNA adsorber used in extracorporeal therapeutic apheresis. It is designed to complement the standard of care by reducing harmful DNA and NETs in the bloodstream of sepsis patients.
Study Design: This is a prospective, multinational, multicentre, randomized, parallel-group, open-label study. Participants are randomly assigned to either receive the standard of care plus the NucleoCapture treatment or the standard of care alone, with no masking involved. The primary purpose is treatment-focused.
Study Timeline: The study was first submitted on December 3, 2022, and the latest update was submitted on November 26, 2024. Recruitment has not yet started, indicating that the study is in its early stages, which is crucial for investors to monitor as it progresses.
Market Implications: The update on this clinical study could influence the stock performance of Santersus AG and its collaborator ISS AG, as successful outcomes may enhance their market position in the medical device industry. Investors should also consider the competitive landscape, as advancements in sepsis treatment are highly sought after.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.
