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Biomechatronics Device for Diagnosis/Therapy of Anorectal Disorders

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44DK129097-02
Agency Tracking Number: R44DK129097
Amount: $1,924,952.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA20-260
Timeline
Solicitation Year: 2020
Award Year: 2022
Award Start Date (Proposal Award Date): 2021-12-01
Award End Date (Contract End Date): 2024-11-30
Small Business Information
11107 Roselle St
San Diego, CA 92121-1206
United States
DUNS: 804419740
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 WILLIAM COMBS
 (317) 274-2268
 wc6307@gmail.com
Business Contact
 JOHN FESSLER
Phone: (510) 205-8626
Email: jfessler@3dtholdings.com
Research Institution
N/A
Abstract

ABSTRACT
Defecatory disorders such as chronic constipation (CC) and fecal incontinence (FI) affect 25% of the population
and the incidence is rising. These disorders pose a major health care burden and are poorly recognized and
treated. The need for better diagnostics and therapeutics is substantial. CC, a symptom of underlying defecatory
disease, affects 12-19% of Americans with expenditure on laxatives being nearly $1B yearly. Another defecatory
disorder is FI, which affects 10% of the population and its incidence is rising. Approximately 15% of the population
in USA over 70 years of age as well as 10% of those under 70 suffer from FI. It is an under-diagnosed problem
due to patients often being too embarrassed to seek medical help. The mechanisms of defecation and continence
depend on colorectal motility, stool consistency, rectal capacity and compliance, anorectal sensitivity, and
coordination of the pelvic floor muscles and sphincter. Management options for these patients are limited due to
the multifactorial control of defecation and continence; and the difficulties in identifying the exact cause of CC
and FI with current diagnostics. Precise diagnosis is necessary to judge if the patient is eligible for biofeedback
treatment. 3DTs multimodal Fecobionics device is a novel, anorectal natural orifice insertable device that
provides high resolution pressures, orientation, bending, and shape during defecation of the device. It simulates
feces and electronically measures relevant parameters of defecation such as the propulsive force, anal sphincter
relaxation, and anorectal angle. Results from previous studies have shown safe and distinctive recordings of
important anorectal function parameters. Specifically, the device did not cause tissue injury to rectum or the anal
canal as verified by visual inspection of mucosa and histological examination. Fecobionics evacuations in non-
GLP pig studies showed characteristic pressure profiles and orientation/bending data obtained with wired as well
as wireless transmission. Furthermore, simultaneous data from human studies outside of the US have provided
the first-in-man studies with the initial wired prototypes of Fecobionics. The human studies have confirmed that
the device is safe and easy-to-use in the clinical setting with integration of most current tests in one, and high
degree of agreement with key parameters obtained with the balloon expulsion test and defecography. Distinct
differences were found, however, when compared to the manometry “gold standard” as there are also difference
between current clinical tests. To advance these outstanding findings and to move closer to commercialization
of Fecobionics, this Fast track proposal intends to accomplish the following: Phase I Aim 1: Modification of filling
tube detachment. We will develop an optimized, easy-to-operate tube with needed retention force and
detachment. Phase II Specific Aims: 1) GLP studies in swine to demonstrate safety, 2) In vivo comparison of
anorectal angle and pressure measurements, and 3) 510(k) submission. To obtain data for submission of 510(k)
for market release of wireless technology. The long-term goal is to develop the technology for biofeedback training
by patients in their homes with remote assistance by practitioners to substantially reduce healthcare costs.

* Information listed above is at the time of submission. *

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