Biomedinnovations, Inc.

Platform for Extended Kidney Preservation via Subnormothermic Perfusion - Kidney Transplantation Is Currently the Optimal Renal Replacement Therapy Due to Reduced Morbidity and Mortality, Better Quality of Life, and Decreased Cost Compared to Dialysis. However, Transplants Remain Severely Limited by a Shortage of Donor Kidneys Available for Transplantation, With Over 90,000 Patients on the Waiting List. This Imbalance in Supply and Demand Has Resulted in a Strong Desire to Use High-risk Kidney Grafts From Older Donors and Donors After Circulatory Death (DCD). These High-risk Kidney Grafts Often Incur Significant Injury During Preservation and Transportation Prior to Transplantation, Leading to Diminished Graft Survival. as Such, High-risk Kidney Grafts Are Discarded at High Rates Because of the Inability to Predict Their Function. to Improve the Preservation and Acceptance of High-risk Kidney Grafts, Including DCD Kidneys, Investigators at the Duke Ex Vivo Organ Lab (DEVOL) and Biomedinnovations LLC (BMI) Have Developed a Unique Subnormothermic (22-25°C, Approximately Room Temperature) Oxygenated Perfusion Platform, Consisting of a Perfusion Device and Matched “devol Solution”. Pilot Studies Using a Porcine Model of DCD Kidney Transplantation Demonstrated Significant Improvements in Post-transplant Kidney Graft Function Versus the Historical Standard of Care, Static Cold Storage (SCS). Consistent With the Niddk Sbir Research Priority “development of Devices or Techniques to Enhance the Long- Term Success of Kidney Transplantation (e.g., Techniques for Kidney Storage and Preservation)”, This Project Will Generate Evidence That the Bmi Platform Provides Superior Performance to the Current Standard of Care for High- Risk Kidneys, Namely Hypothermic Machine Perfusion (HMP). Availability of This Data Would Result in This Technology Rapidly Moving Forward to Commercialization. the Project Includes Specific Aims to 1) Optimize the Engineering Aspects of Bmi’s Platform (consisting of the Device and Perfusate); 2) Determine, Ex-vivo, the Impact of Warm Ischemic Injury and Duration of Device Preservation on Kidney Graft Injury for the Bmi Platform Versus the Current Standard of Care; and 3) Compare the Function of High-risk Kidney Grafts Preserved With the Bmi Platform Versus the Current Standard of Care Using a Porcine Kidney Auto-transplant Model. the Outcome of This Project Will Include Preclinical Evidence That Demonstrates That Bmi’s Platform Is Likely to Provide a Meaningful Advance Over the Current Standard of Care When Used in Humans and Advance the Platform Towards Commercialization. This Will Help Bmi to Secure Further Investment, Successfully Engage With Regulators and Ultimately, Gain Customer Adoption That Leads to Improved Access to Kidneys for Those on the Transplant Waiting List.