Our overall strategy for the company is to utilize microphysiological systems in combination with functional readouts to establish platforms capable of sophisticated analysis of chemicals and drug candidates for toxicity and efficacy during pre-clinical testing, with initial emphasis on predictive toxicity. This is a service based company that is developing low-cost in vitro systems containing a novel pumpless microphysiological platform and serum-free medium formulation. The pumpless integrated system, using a rocking motion to pump the cellular medium, reduces the complexity and cost of the fluidic circuit design and simplifies set-up and operation of the device. The system employs microelectrode arrays and cantilever systems that are integrated on chip to allow for noninvasive electronic and mechanical readouts. These functional readouts greatly reduce the number of biomarkers to be monitored for cell health and function in our systems. We have constructed physiological systems that represent cardiac, muscle, neuronal and liver function that are already being evaluated and utilized for testing in Hickman's lab by pharmaceutical and cosmetic companies. We also have functional, prototype system for human neuromuscular junction, and an integrated 4-organ system consisting of cardiac, liver, neuronal and skeletal muscle compartments. These devices are currently under validation studies and are available as a service for use by industry and government and we are negotiating with major pharmaceutical companies now to utilize these systems. However, all current systems are fabricated and assembled by hand and this factor will continue to hinder production of these systems. In this proposal, advanced manufacturing techniques will be utilized and developed to increase rates of fabrication and testing and lower cost by an order of magnitude. We will partner with NIST to develop these advanced manufacturing techniques and take advantage of Hickman's long association with Dr. Michael Tarlov's group in the Biomolecular Measurement Division. These systems will be tested with drugs that have known multi-organ interactions and ones that target single organs and the results will be compared to human clinical responses. In particular, we will determine whether the system would predict semi-quantitative multi-organ responses to chemicals of interest to the pharmaceutical and cosmetic industries. Dr. Shuler has pioneered the Body-on-a-Chip system, a realistic multi-organ platform using cell cultures to predict human response to drugs and biologics and will create a next-generation device. Dr. Hickman has developed functional in vitro human physiological systems and integrated them onto the microphysiological platform in serum-free medium formulations.

Public Health Relevance

The overall strategy for the company is to utilize organ-on-a-chip systems and sensors to model body organs such as the nervous system, circulatory system and gastrointestinal tract system and offer this as a service to pharmacology companies who seek analysis of potential drug candidates. This system can be utilized in drug discovery and toxicity studies and shows potential of decreasing the cost of the drug development process which should led to less expensive drugs for the public at large.

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
1R44TR001326-01A1
Application #
9057338
Study Section
Special Emphasis Panel (ZRG1-IMST-M (13)B)
Program Officer
Tagle, Danilo A
Project Start
2016-09-01
Project End
2018-08-31
Budget Start
2016-09-01
Budget End
2017-08-31
Support Year
1
Fiscal Year
2016
Total Cost
$1,241,321
Indirect Cost
Name
Hesperos, LLC
Department
Type
DUNS #
079563251
City
Orlando
State
FL
Country
United States
Zip Code
32826
Chen, Huanhuan Joyce; Miller, Paula; Shuler, Michael L (2018) A pumpless body-on-a-chip model using a primary culture of human intestinal cells and a 3D culture of liver cells. Lab Chip 18:2036-2046
Wang, Ying I; Shuler, Michael L (2018) UniChip enables long-term recirculating unidirectional perfusion with gravity-driven flow for microphysiological systems. Lab Chip 18:2563-2574
Wang, Ying I; Carmona, Carlos; Hickman, James J et al. (2018) Multiorgan Microphysiological Systems for Drug Development: Strategies, Advances, and Challenges. Adv Healthc Mater 7:
Wang, Ying I; Oleaga, Carlota; Long, Christopher J et al. (2017) Self-contained, low-cost Body-on-a-Chip systems for drug development. Exp Biol Med (Maywood) 242:1701-1713
Miller, Paula G; Wang, Ying I; Swan, Glen et al. (2017) A simple cell transport device keeps culture alive and functional during shipping. Biotechnol Prog 33:1257-1266