Xvivo Perfusion AB ((XVIPF)) announced an update on their ongoing clinical study.
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Study Overview: The study titled ‘PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol’ aims to assess the safety and efficacy of the XVIVO Heart Preservation System (XHPS) for preserving and transporting hearts from extended criteria donors for transplantation. This research is significant as it could enhance heart transplant outcomes and expand donor heart availability.
Intervention/Treatment: The intervention being tested is the Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT). This device is designed to preserve donor hearts by maintaining them in a non-ischemic state, potentially improving transplant success rates.
Study Design: The study is interventional with a single-group assignment. It is open-label, meaning there is no masking, and its primary purpose is treatment. This straightforward design allows for direct observation of the intervention’s effects on heart preservation.
Study Timeline: The study began on March 18, 2025, with the latest update submitted on October 7, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.
Market Implications: The ongoing study by XVIVO Perfusion AB could positively impact its stock performance by demonstrating the effectiveness of its heart preservation technology. Success in this study may enhance investor confidence and position XVIVO as a leader in the organ preservation market, potentially affecting competitors who are also developing similar technologies.
The study is currently recruiting, with further details available on the ClinicalTrials portal.