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

• BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys
• FDA Breakthrough Device Designation secures additional FDA engagement in advance of clinical studies planned for next year

WINSTON-SALEM, N.C., Aug. 4, 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. David A. Gerber, MD, abdominal transplant surgeon and Chief Medical Officer stated “We are energized by our promising preclinical data. The timing of this news is outstanding as my colleagues and I participate in the World Transplant Congress this week.”

About BMI OrganBank®

BMI OrganBank specializes in developing transformative perfusion systems for organ and tissue evaluation and preservation. With facilities at the Innovation Quarter in Winston-Salem, NC, and Research Triangle Park, NC, the company is advancing multiple medical devices that use its patented and proprietary technologies. Its flagship product, the portable OrganBank kidney device, was co-developed with leading transplant surgeons and is set to begin clinical studies soon. Learn more at www.bmiorganbank.com 

Media Contact
Robert Neusner
President and Chief Operating Officer
RNeusner@BMIOrganBank.com

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