BMI OrganBank, a pioneering leader in organ assessment and preservation, has received the prestigious Breakthrough Device Designation from the U.S. Food and Drug Administration for its revolutionary kidney preservation device. The designation, announced on August 4, 2025, recognizes the transformative potential of the company's room temperature machine perfusion platform to significantly improve outcomes for transplant patients.
Addressing Critical Limitations in Current Kidney Preservation
Current kidney perfusion technologies rely on cold storage temperatures, which present significant challenges for transplant medicine. With existing methods, it is difficult to evaluate kidney function before transplantation, and organs are vulnerable to significant injury during the storage period. These limitations result in a large proportion of donated kidneys remaining unused, contributing to persistently long transplant waitlist times.
BMI OrganBank's groundbreaking room temperature machine perfusion (RTMP) platform was developed in collaboration with leading transplant surgeons and academic medical centers. The technology shows great promise to facilitate kidney quality assessment and extend preservation times, potentially increasing the number of kidneys available for transplant.
Clinical Development and FDA Engagement
The Breakthrough Device Designation secures expedited FDA engagement in advance of clinical studies planned for early next year. This regulatory milestone represents a significant step forward for the company's flagship product, the portable OrganBank kidney device, which was co-developed with leading transplant surgeons.
"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 of BMI OrganBank.
David A. Gerber, MD, abdominal transplant surgeon and Chief Medical Officer, expressed enthusiasm about the company's progress: "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."
Company Profile and Technology Platform
BMI OrganBank specializes in developing transformative perfusion systems for organ and tissue evaluation and preservation. The company operates facilities at the Innovation Quarter in Winston-Salem, North Carolina, and Research Triangle Park, North Carolina, where it is advancing multiple medical devices using its patented and proprietary technologies.
The company's mission focuses on developing novel medical devices with the potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys. The breakthrough designation underscores BMI OrganBank's commitment to advancing technologies that address critical unmet needs in transplant medicine.
