emuLAAte: atraumatic patient-specific stroke prevention technology

Spheric Bio Inc, Wilmington DE

Investigators

Abstract

Project Summary: Atrial fibrillation (AF) will affect >12 million Americans by 2030. AF leads to a 5-fold increased risk of stroke, a leading cause of death and disability costing >$50 billion/year in the US. Over 90% of stroke-causing clots in AF patients form in the left atrial appendage (LAA); thus, occlusion of the LAA (LAAO) offers a promising alternative to long-term blood-thinners. However, LAAO is hindered by incompatibility between standard off-the-shelf devices and real human patients. FDA-approved LAAO devices are metallic, round, and pre-fabricated in limited sizes, whereas human LAAs are composed of complex, delicate tissues in a limitless range of shapes and sizes. This fundamental geometric and mechanical incompatibility can lead to incomplete occlusion (~25-50% of cases), challenging clinical workflows, tissue trauma, and suboptimal stroke prevention. To solve this, Spheric Bio is developing the emuLAAte platform to assemble fully-soft, personalized implants directly inside the patient’s body through a minimally-invasive approach. By delivering, forming, and stabilizing soft biomaterials at the target site, we can generate atraumatic intracardiac implants that match each patient’s unique anatomy. This could simultaneously address the persistent patient-device mismatch and device-anatomy alignment issues to improve stroke prevention in a safer and simpler clinical workflow. To date, our team has already developed an initial emuLAAte prototype, conducted early benchtop and acute large animal tests, and interviewed >100 LAAO stakeholders. At this stage, the most critical technical and clinical risk is the reliable anchoring of the soft shape- matching implant inside the intracardiac environment. Our Phase I project conclusively addresses this risk via two aims. Aim 1: Design, characterization, and benchtop verification of a tissue-facing anchoring system that supports transcatheter delivery and effectively engages and secures the 3D implant in the dynamic cardiac environment. Aim 2: Two-phase validation study in a large animal (porcine) model: first phase demonstrating acute anchoring success and second phase establishing long-term anchoring stability and preclinical safety outcomes in a chronic trial. PI development: Holistic plan includes coursework, programs, and assignments to learn and implement essential technology translation skills, augmented by regular engagement with diverse mentors for critical personal and project feedback and exposure to different entrepreneurial perspectives. After Phase I completion, we’ll have de-risked the most significant remaining engineering challenge and concretely demonstrated technical feasibility and clinical potential for our emuLAAte platform in a living, beating heart. Further, the PI will develop the skills and confidence to drive technology translation and establish a career as a biomedical entrepreneur. Accordingly, Phase I provides a solid foundation to address further product design, usability, manufacturing, and clinical deployment concerns in Phase II. Our approach for on-demand, in situ formation of atraumatic patient-specific implants would be a paradigm shift in device-based stroke prevention for the millions of patients living with atrial fibrillation.