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In Vivo Simulation & Biocompatibility Testing
Before clinical translation, all constructs undergo in vivo simulation using high-fidelity animal models and AI-augmented tissue behavior prediction. This includes immunogenicity profiling, mechanical stress testing, and integration performance metrics to validate safety and efficacy.
Our integrated methodology stack is designed for scalability, regulatory compliance, and translational impact—building the bridge from lab-bench validation to patient-ready bio-prosthetics.
To restore sensory and motor function, we develop bioelectronic interfaces and neuro-compatible conduits. These frameworks support the alignment and reconnection of regenerated nerve fibers with host tissue, enabling closed-loop neuromuscular integration.
Neural Interfacing Frameworks
Our platform leverages induced pluripotent stem cells (iPSCs) derived from the patient’s own tissue. These are reprogrammed into specific cell types—such as myocytes, neurons, and endothelial cells—enabling immunologically matched, functional grafting into bioprinted prosthetic structures.
iPSC Reprogramming & Cell Engineering
We employ perfusable microvascular networks within our tissue constructs to ensure nutrient diffusion, waste clearance, and long-term cell viability. This includes both pre-vascularized scaffolds and endothelialized flow chambers designed to model in vivo-like blood flow dynamics.
Vascularization Models
Phase One
Feasibility & Platform Design
This phase establishes the foundational science and technological framework required to engineer living prosthetics. We investigate biomaterials, analyze optimal cell sourcing strategies (including stem cells and iPSCs), and evaluate bioprinting techniques for scalability and biological fidelity. The objective is to validate the scientific feasibility of creating fully vascularized, innervated, and mechanically functional prosthetic tissue structures from patient-derived cells.
Our Research
At Shanahan Bio Prosthetics, our research pioneers the future of regenerative prosthetics through a 12-paper series exploring the intersection of biotechnology, tissue engineering, and clinical application. Spanning foundational cell sourcing to vascularized limb bioprinting and regulatory validation, this body of work outlines a full translational pathway—from bench to patient. Each paper builds on the last, addressing functional tissue integration, immunogenicity, nerve connectivity, and scalable manufacturing. Our mission is to redefine human restoration by engineering personalized prosthetic limbs using the patient’s own cells—ethically, precisely, and at clinical scale.
Tissue Engineering for Bio-Prosthetics: A Research Proposal & Feasibility Study
Biomaterials for Bioprinted Prosthetic Limbs: A Comparative Analysis
Cell Sourcing for Bioprinting: Stem Cells vs. iPSCs for Prosthetic Integration
Bioprinting Techniques for Prosthetic Limb Development
Phase Two
Tissue Development & Integration
Here, we shift from theory to function—developing and optimizing lab-grown tissues that mimic real human anatomy. This includes engineered vascular networks, nerve conduits, skeletal muscle scaffolds, and biomechanical load-bearing structures. Emphasis is placed on tissue integration, sensory-motor interface design, and biomimetic durability to ensure biological and mechanical coherence within the host body.
Vascularization Strategies for 3D-Bioprinted Prosthetic Limbs
Biointegration of Prosthetic Limbs with Nerve Systems
Biomechanical Properties of Bioprinted Prosthetic Tissue
Phase Three
Clinical Readiness & Commercialization
In the final phase, we translate research into viable clinical and commercial solutions. This includes biocompatibility validation, in vivo testing, immune response profiling, and regulatory alignment (TGA, FDA). We also explore scalable manufacturing pipelines and patient-specific customization workflows. The goal is to achieve a fully compliant, implant-ready prosthetic limb platform capable of real-world application.
Immunogenicity & Biocompatibility of Bioprinted Prosthetics
In-Vivo Testing of Bioprinted Prosthetic Limbs in Animal Models
Regulatory Challenges in Bioengineered Prosthetics
First-in-Human Clinical Trial of a Bioprinted Prosthetic Limb
Commercialization & Manufacturing of Bioprinted Prosthetic Limbs
Research Methodologies Used
Research Methology
At Shanahan Bio Prosthetics, we combine cutting-edge biotechnology, precision engineering, and translational research workflows to redefine what prosthetics can achieve. The following core methodologies underpin our platform: