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PuLMo V 2.0: Miniaturized Artificial, Configurable Human Lung System of Systems for Accelerated Toxicological Studies

Stage: Prototype

The Pulmonary Lung Model (PuLMo) Version 2.0 is a miniaturized, engineered human artificial lung organ, designed to mimic the responses of human lungs to pharmaceuticals, toxins, and other agents. It can be customized in a system of systems implementation to reduce the life-cycle time and cost of pulmonary toxicological studies.



The PuLMo Technology provides a means of performing direct and reliable efficacy and toxicity assessment of therapeutic drugs and chemicals in human lungs, significantly reducing the in life-cycle time and cost of drug testing while facilitating the rapid development of effective countermeasures to biological, chemical, and disease related modalities. PuLMo V2.0 system consists of an integrated bronchiolar and alveolar lung tissue units with miniaturized made to spec pumps, tubes, enabling fluid and air flows through the units for the long-term sustenance of key physiological and functional characteristics of the human lung. The system is the result of multiple innovations, designs, and testing of stand-alone units and functionalities and is backed up by several U.S. patents. 1) Long-term cell differentiation allows study of effects of pharmaceuticals in real-time in a visible, see-through bioreactor with integrated perfusion. 2) The ability to integrate breathing with co-culture of lung-specific human cells in an air-liquid interface – the system couples a breathing alveolus with an upper respiratory tract with a stretchable porous membrane interface. 3) Maintenance of cellular differentiation as long as 140 days for upper and 14 days for lower respiratory tracts. 4) Significant scientific and engineering experience and expertise in designing, engineering, and testing organ on- a-chip systems. We are seeking an industrial partner to implement a complete toxicological study protocol using a networked PuLMo V2.0 System of Systems through the use of a Collaborative Research and Development Agreement (CRADA).

Applications and Industries

On average, only one in 5,000 pharmaceuticals that enter pre-clinical studies becomes an approved drug; and the therapeutic area with the highest clinical research burden across all phases of development is the respiratory system at an average cost greater than $115 million USD per drug developed. There is an ever increasing need to develop a more rapid screening approach to develop lifesaving drugs while reducing development and consumer costs. Toxicological studies, conducted to translate animal responses to drugs or chemicals, is an integral part of pre-clinical studies involving animal subjects. PuLMo V2.0 technology provides an opportunity to reduce/replace animal subjects with relevant and more targeted human lung organ and tissues systems for direct assessment of pulmonary responses to a drug, potentially providing a bridge between animal studies and human trials. The technology also provides a means to explore the potential of personalized medicine.

Benefits

    Mimics realistic human lung architecture and functionality by integrating bronchiolar and alveolar tissues
    Reduces life-cycle time, duration, and cost of pulmonary toxicological studies for drugs, chemicals, and disease monitoring
    Extensible to simultaneous execution of multiple toxicological experiments in a customizable system of systems setting
    Provides a bridge between animal studies and human trials
    Provides a means to facilitate personalized medicine

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