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Fecobionics device for mapping colonic and anorectal neuromuscular function

Award Number: OT2OD025308
ORGANIZATION: OFFICE OF THE DIRECTOR, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: OTHER
PERIOD OF PERFORMANCE START DATE: 09/22/2017
PERIOD OF PERFORMANCE END DATE: 10/31/2020

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Fecobionics device for mapping colonic and anorectal neuromuscular function - The colon and anorectum have complex composition. Methods to study neuromuscular interactions and activity in health and gastrointestinal (GI) disease have been limited due to difficult access and lack of appropriate technologies. Many aspects of colonic mechanosensory physiology are still not well understood including the influence of enteric circuits and reflexes, and extrinsic nerve function in the various segments of the colon. The need for new technology and a better understanding of the neuromuscular function is substantial. A significant problem is a lack of physiologically-relevant and practical test for identifying the underlying mechanism(s). Hence, the overall objective is to validate a fully integrative dynamic tool that mimics feces transport in the lower GI tract. Accordingly, the following tasks are proposed: 1) Optimization of a wireless development of Fecobionics device and System for neuromuscular function studies of the colon. Milestone: Wireless device that can record during transport through colon and anorectum; 2) Conduct safety and performance studies in dogs (including IDE approval): Milestone: Studies that demonstrates safety and performance of the device under different neuromuscular conditions; and 3) Develop a validated mathematical model of the lower GI tract. Milestone: Geometric and functional mathematical model for colonic transport and defecation. The proposed technology (Fecobionics) is a simulated electronic feces that has the consistency and shape of normal stool. The measured variables in Fecobionics include multiple pressures, shape changes, velocity and orientation. Hence, it will be feasible to map and describe objectively (without disturbing the colonic transport and defecation processes) the transport characteristics and neuromuscular signatures during colonic transport and initial entry from the rectum into the relaxing anal canal. This unique device will provide new neuromuscular signatures of the lower GI tract under normal circumstances, and during intervention with enteric and peripheral nerve activity to enhance our understanding of physiological and pathophysiological mechanisms involved in the lower GI tract neuromuscular function. In line with SPARC mission, we intend to provide a new technology for lower GI testing, simulating normal stool transport and defecation with a bionics device. This technology will replace several current tests, because it provides an integrated frame work for assessing function and obviates the need for multiple tests of function. The central premise is that a novel and unique Fecobionics device that mimics natural lower GI transport will provide new mechanistic insights regarding colonic and anorectal physiology when compared to standard tests and facilitate development of new diagnostics for lower GI disorders. The significance is to address the major gaps in knowledge by developing a safe, low cost, less invasive, low risk, radiation-free device, and test its ability to provide new understanding of colonic neuromuscular and defecation function. This may later facilitate development of diagnostic and therapeutic tools that will reduce healthcare costs.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2017	CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC., THE	11107 ROSELLE ST	SAN DIEGO	CA	92121	SAN DIEGO	USA	Trans-NIH Research Support	000	1	4/27/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $1,675,013 )
2018	2018	CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC., THE	11107 ROSELLE ST	SAN DIEGO	CA	92121	SAN DIEGO	USA	Trans-NIH Research Support	002	1	6/6/2018	SUPPLEMENT FOR EXPANSION	$1,675,013
2018	2018	CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC., THE	11107 ROSELLE ST	SAN DIEGO	CA	92121	SAN DIEGO	USA	Trans-NIH Research Support	003	1	9/7/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2017	CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC., THE	11107 ROSELLE ST	SAN DIEGO	CA	92121	SAN DIEGO	USA	Trans-NIH Research Support	000	1	3/5/2018	NEW	$0
2018	2017	CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC., THE	11107 ROSELLE ST	SAN DIEGO	CA	92121	SAN DIEGO	USA	Trans-NIH Research Support	001	1	4/17/2018	NEW	$0
														Subtotal = $1,675,013

Issue Date FY: 2017 ( Subtotal = $249,466 )
2017	2017	CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC., THE	11107 ROSELLE ST	SAN DIEGO	CA	92121	SAN DIEGO	USA	Trans-NIH Research Support	000	1	9/22/2017	NEW	$249,466
														Subtotal = $249,466

Grand Total All Awards = $1,924,479

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Fecobionics device for mapping colonic and anorectal neuromuscular function

Award Number: OT2OD025308

ORGANIZATION: OFFICE OF THE DIRECTOR, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: OTHER

PERIOD OF PERFORMANCE START DATE: 09/22/2017

PERIOD OF PERFORMANCE END DATE: 10/31/2020

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