BMI OrganBank, a frontrunner in the field of organ assessment and preservation, has announced a major milestone: its innovative organ preservation device has been granted the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognition, specifically awarded for their novel kidney preservation system, highlights the company’s dedication to developing advanced medical technologies that aim to significantly enhance the outcomes of organ transplant procedures.
Traditional kidney perfusion methods, which rely on cold storage, present significant limitations. These techniques make it difficult to assess the viability of organs prior to transplantation and often expose the kidneys to damage during storage. As a result, many potentially viable kidneys are ultimately discarded, limiting access for patients on transplant waitlists. This inefficiency contributes to the continued shortage of usable donor kidneys and prolongs wait times for thousands of patients in need.
An innovative substitute is provided by the room temperature machine perfusion (RTMP) platform from BMI OrganBank. Designed in partnership with top transplant surgeons and academic medical institutions, the RTMP technology has demonstrated strong potential to improve organ viability by enabling functional assessments at room temperature and allowing for longer preservation times. This new approach could be a critical advancement in the quest to expand the pool of transplantable kidneys and reduce the burden of extended waiting periods for patients.
The company is planning to initiate clinical trials in the near future, with preparations already underway. Carrie DiMarzio, CEO and Co-Founder of BMI OrganBank, expressed gratitude for the FDA’s designation, stating the team is eager to collaborate further as they move toward human trials. Dr. David A. Gerber, Chief Medical Officer and a practicing abdominal transplant surgeon, shared that the announcement comes at a pivotal time, aligning with their participation in the World Transplant Congress. He emphasized the momentum generated by positive preclinical results and the excitement surrounding the potential impact of this technology.
