Biomembretics, Inc.

Manufacturable Biomimetic Microfluidic Oxygenator for Safer, Simpler Treatment of Respiratory Failure - Project Summary/abstract This Fast Track STTR Project Focuses on Developing and Demonstrating a High-volume Manufacturing Technology for Microfluidic Oxygenators for Applications Requiring Extracorporeal Membrane Oxygenation (ECMO) to Treat Respiratory Failure. Unlike Heart Disease and Cancer, Mortality From Lung Diseases Continue to Rise, and a Combination of Increasing Patient Populations Suffering From Chronic Obstructive Pulmonary Disease and Acute Lung Injury Associated With Respiratory Infectious Diseases and Trauma Represent an Enormous Health Care Challenge in the Us and Across the World. the Gold Standard Treatment for Respiratory Failure, Invasive Mechanical Ventilation, Carries Significant Risks of Mechanical and Biochemical Injury to the Lung Along With Microbial Exposure. as a Result, Ecmo Has Emerged as an Alternative Therapy That Allows Injured Lungs to Rest, Directly Oxygenating and Removing Carbon Dioxide From the Blood in an Extracorporeal Circuit. However, Ecmo Use Is Limited Due to the Extreme Complexity of the Blood Circuit, Which Includes a Hollow Fiber Membrane Oxygenator (HFMO) as the Functional Unit, and Bioinspired Microfluidic Oxygenators Capable of More Safely Oxygenating the Blood Have Emerged. Our Preliminary Data Demonstrates the First Large-scale, Extended Duration Microfluidic Oxygenators in Large Animals, With Distinct Safety and Efficacy Advantages Over Hfmo, But the Method of Construction Is Very Complex and Costly. We Have Engaged With High Precision Injection Molding Companies to Identify a Path to Produce the Devices at High Volume and Low Cost, and the Focus Here Is to Develop and Demonstrate the Injection Molded Microfluidic Oxygenator Technology in Safety and Efficacy Studies in a Porcine Model. Toward This End, We Propose a Fast Track Proposal Comprising Two Phases and Four Overall Aims. in Phase I, We Will 1) Define the Target Product Profile for the Adult Clinical Scale Microfluidic Oxygenator and Conduct Fluid Mechanical and Thermal Modeling to Identify the Process Window Required for High Yield Injection Molding of These Devices, 2) Iteratively Apply Computational Models to Verify the Oxygen Transfer and Blood Flow, Pressure and Shear Properties of Oxygenators Resulting From These Designs, and 3) Build a Casted Replica of the Injection Molding Design to Confirm Gas Transfer Performance. Successful Identification of a Microfluidic Oxygenator Design That Meets the Requirements From Manufacturability, Cost and Performance Perspectives Will Lead to Advancement to Phase Ii of the Program. Here We Will 1) Fabricate the Injection Molds Required for Fabrication or Larger Numbers of Microfluidic Oxygenators at Pediatric and Adult Scale, and 2) Test These Pediatric and Adult Scale Oxygenators in Extended Duration Studies in Porcine Models to Confirm Safety and Efficacy in Comparison With Hfmo Control Devices. This Demonstration of Safety and Efficacy, Enabled by the High-volume Injection Molding Process Developed on This Project, Will Accelerate the Advancement of the Technology Toward Commercialization and Clinical Translation for Treatment of Critically Ill Patients Suffering From Respiratory Failure.