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LEARNING

Research & Development

Design, test and clinically evaluate devices; identify the root cause of device malfunctions; navigate the regulatory process by identifying risks

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UNDERSTANDING

Tissue Response

Understand how to coax cell growth over implantable devices; the response of excitable cells to an implant; cellular responses to different scaffoldings, materials, and coatings

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EVALUATE

Risk Analysis

Anticipate and manage device failures and medical issues that may arise during the course of clinical studies

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QUESTION

Experimental Design

Models demonstrating accurate anatomy and physiology allow for improved experimental design in defining the questions that show device efficacy

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TEACHING

Physician Training

Increased use and complexity of medical devices require increased physician training. Models with accurate pathology and anatomy are created using human or animal cells, organs, or full donors

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PLAN

Usability & Workflow

Usability data and physician feedback allow for relevant IFU creation and clinical preparation. Procedure development and imaging workflow set the script for a successful clinical experience

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About Our Mission

Our team serves patients and clients through a comprehensive preclinical partnership that involves device development and testing, offering custom and standardized in-vitro laboratory services, and creating new test models and test systemsOur commitment is to the patients who will receive the therapies that pass through our laboratories & the clients who are involved in their development, testing, and training.

Where Did We Start?

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2020

Founded BioSim Innovations, LLC, and began creating biosimulation models.

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2024

Moved into 42,000 sq ft facility to expand capabilities, facilities, advanced imaging, and expertise.

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2019

Observed a need for better translational models to evaluate medical devices and therapies that focus on human clinical relevance and animal in vivo alternatives (NAM- New Alternative Methodologies).

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2022

Expanded physical footprint with procedure room and in vitro lab.

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2026

Hub for physician & engineering engagement. Full Wheel of Services implemented with synergistic biosimulation, in-vitro, histopathology, in vivo, and product development services, returned product decontamination, supported by AAALAC, GLP, and forecasted end-of-2026 ISO 17025 and ISO 13485 compliance.

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