BMI OrganBank awarded $3.5 Million NIH grant

BMI OrganBank has secured a $3.5 million federal grant that will help the Winston-Salem company advance its kidney preservation technology and prepare for clinical trials.

The Phase 2 Small Business Innovation Research (SBIR) grant from the National Institutes of Health is a significant milestone for the five-year-old company, CEO Carrie DiMarzio said in a statement.

“This funding will not only accelerate the development of our kidney preservation technology but also bring us closer to addressing the urgent need to increase the transplantation of donated kidneys,” DiMarzio said.

In addition, the Piedmont Triad Regenerative Medicine Engine (PTRME), funded by the National Science Foundation (NSF), recently awarded six regional companies $2.5 million in grants as part of its inaugural Ecosystem Building Grant program - BMI OrganBank was one of the six.

Addressing organ shortages

BMI OrganBank said it had achieved promising preclinical results with Duke University’s Ex Vivo Organ Laboratory. The results showed the potential for assessing organ quality and extending preservation times outside the body through BMI OrganBank’s system for warm perfusion, a process that forces blood flow through the organ while it’s maintained at room temperature. The company has worked with the Duke lab since 2020 to develop its perfusion technology.

Improvements in organ preservation are needed to help address the high demand for transplants with a limited supply of organs. Almost 90,000 Americans are on kidney transplant waiting lists, according to the federal Human Resources and Services Administration.

Current technologies are based on cold perfusion, which can make it difficult for clinicians to evaluate the quality of organs and leave organs subject to injury. Warm perfusion is considered an improvement because it can improve quality assessment, extend preservation time, and potentially help reduce the shortage of organs available for transplants.

University collaborations

BMI OrganBank collaborates with two universities as it prepares for clinical trials and seeks approval from the U.S. Food and Drug Administration: Duke’s ex vivo organ lab and the UNC Kidney Center at the University of North Carolina at Chapel Hill.

The company’s president and chief operating officer, Robert Neusner, co-leads the warm perfusion project with Duke’s Andrew Barbas, MD, a transplant surgeon, and UNC’s Prabir Roy-Chaudhury, MD, a nephrologist and co-director of the UNC Kidney Center.

In March, the company announced a partnership with Atrium Health’s Division of Abdominal Transplant and with LifeShare Carolinas, one of North Carolina’s largest organ procurement organizations. The partnership is expected to include product development, clinical studies, pilots, and educational programs.

Kyle Bartholomew, director of investments for emerging company development at the North Carolina Biotechnology Center, said BMI OrganBank’s progress since its founding in 2019 shows there is strong potential for increasing the supply of suitable organs.

“This is an example of a company working to meet a critical need in healthcare,” he said. “The team at BMI OrganBank and the researchers in North Carolina that they’re working with are helping lead the way toward reducing or eliminating organ transplant waiting lists.”

In 2023, BMI OrganBank received a $250,000 Small Business Research Loan from NCBiotech. The company has research facilities at the Innovation Accelerator at the Wake Forest Institute for Regenerative Medicine and in Research Triangle Park.