BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology

WINSTON-SALEM, N.C., Aug. 04, 2025 /PRNewswire/ -- BMI OrganBank, a pioneering leader in organ assessment and preservation, proudly announces that its revolutionary organ preservation device has received the prestigious Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation, granted for their kidney preservation device, underscores BMI OrganBank's commitment to advancing transformative technologies that will significantly improve outcomes for transplant patients. With current kidney perfusion technologies, which use cold storage temperatures, it is difficult to evaluate the function of kidneys before transplant. Furthermore, they are vulnerable to significant injury during the storage period before transplantation. As such, a large proportion of donated kidneys remain unused. BMI OrganBank's groundbreaking room temperature machine perfusion (RTMP) platform, developed in collaboration with leading transplant surgeons and academic medical centers, shows great promise to facilitate kidney quality assessment and extend preservation times. BMI OrganBank intends to increase the number of kidneys available for transplant and address stubbornly long kidney transplant waitlist times. A clinical study is planned for early next year. "We are incredibly honored to receive this significant designation from the FDA and look forward to working with them as we prepare for clinical studies" stated Carrie DiMarzio, Chief Executive Officer and Co-Founder.