Lazarus 3D, Inc.

Development and Validation of a High-fidelity Cardiac Presurgical Planning Platform for Congenital Heart Defects Using 3D Printing Technology - Development and Validation of a High-fidelity Cardiac Presurgical Planning Platform for Congenital Heart Defects Using 3D Printing Technology Background: Congenital Heart Defects (CHD) Affect 1% of Infants Annually, With Greater Risk to Children Born Into Low Socioeconomic Status. Many CHD Are Associated With High Infant Mortality Rates Such as Hypoplastic Left Heart Syndrome (HLHS), a CHD Which Is Fatal Unless Treated With Complex Surgical Interventions. by Creating Pre-sure-chd, a Patient-specific Preoperative Surgical Rehearsal and Planning Platform, Lazarus 3D Will Facilitate Rehearsal of These Complex Cases, Improving Survival Rates for Infants Born With CHD - Particularly Those With Low Socioeconomic Status. Objective: to Develop and Validate Pre-sure-chd, Enhancing Surgical Planning and Rehearsal for CHD by Providing Surgeons With Operable, High-fidelity, Patient-specific Models. Methods: the Study Comprises Three Specific Aims: Aim 1 Involves Optimizing Synthetic Materials to Replicate the Mechanical Properties of Cardiac Tissues, Ensuring Realism in the Pre-sure-chd Models. Aim 2 Utilizes Proprietary 3D Printing Technology to Create Patient-specific Prototypes for Real CHD Cases, Informed by CT and Mri Imaging Data. Aim 3 Assesses the Content and Construct Validity of Pre-sure-chd Through Surgical Planning Refinement, Recording Changes, and Collecting Metrics for Analysis. Results: the Study Aims to Achieve Milestones, Including Tuning Polymers to Mimic Cardiac Tissue Properties, Completing Pre-sure-chd Prototypes, and Obtaining a Likert Scale Survey Score >3.5 and a 10% Improvement in Surgical Metrics. Conclusion: Successful Completion of This Project Will Provide the First Cardiothoracic Surgical Rehearsal Platform for CHD, Empowering Surgeons to Optimize Their Approaches in a Risk-free Environment. Implications: Pre-sure-chd Holds the Potential to Revolutionize Surgical Planning for Critical Congenital Heart Defects, Reducing Mortality Rates Associated With These Conditions. the Project's Success Will Pave the Way for a Future Phase Ii Clinical Study and Collaborations With Medical Institutions, Ultimately Contributing to Improved Patient Outcomes and Healthcare Advancement.