BMI OrganBank Earns FDA Breakthrough Device Designation for Kidney Preservation System

WINSTON-SALEM, NC – February 24, 2026 – A regenerative medicine company working out of North Carolina’s biomanufacturing corridor has cleared a major regulatory hurdle on the way to changing how donor kidneys move from lab to patient.

BMI OrganBank received FDA Breakthrough Device Designation in 2025 for its kidney preservation technology, and the company has since completed a Good Laboratory Practice (GLP) preclinical study clearing the way for its OrganBank Kidney system, known as OBK, to move into clinical translation.

The technology tackles two problems that have long slowed regenerative medicine products from reaching the clinic: getting living organs and tissue safely from the manufacturing site to the patient and confirming that the tissue is still viable once it arrives. More than 100,000 people in the United States are on transplant waiting lists at any given time, and delays or uncertainty around organ viability can mean the difference between a successful transplant and a missed opportunity.

BMI OrganBank developed the technology as one of six companies selected for a regional Ecosystem Award through the Regenerative Medicine Engine in North Carolina — a $500,000, 15-month award aimed at companies with regenerative medicine products nearing commercialization but still facing barriers to market entry. Since receiving the award, the company’s technology has advanced to a technology readiness level of 6, with a high readiness score on the separate scale evaluators use to judge how close a product is to real-world adoption.

The FDA’s Breakthrough Device Designation is meant to speed the development and review of devices that offer more effective treatment for life-threatening conditions, giving companies more frequent interaction with the agency as they move toward approval.

About RegMIC: RegMIC is an industry-led organization dedicated to accelerating the development and commercialization of regenerative medicine therapies. The organization convenes industry leaders, researchers, and innovators to address critical challenges and advance the field. For more information, visit https://remdo.com/regmic/.

About ReMDO:  The RegenMed Development Organization (ReMDO) is a 501(c)3 non-profit with a mission to help deliver on the promise of regenerative medicine by advancing research to de-risk technologies, promoting progress of biomanufacturing scale-up and automation to make technologies more affordable, and speeding up the translation to clinical practice. For more information, visit https://remdo.org/.