You are here

INTRA-LUMENAL ROBOT FOR MINIMALLY-INVASIVE GI PROCEDURES

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N/A
Agency Tracking Number: 1R43DK059027-01
Amount: $99,497.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
BOX 71, ETNA RD
HANOVER, NH 03755
United States
DUNS: 072021041
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 W STACY
 () -
Business Contact
Phone: (603) 643-3800
Email: WRB@CREARE.COM
Research Institution
N/A
Abstract

DESCRIPTION (Verbatim from the Applicant's Abstract): This Phase I SBIR
application seeks support to develop and evaluate the use of an extracellular
matrix (ECM) bioscaffold derived from the urinary bladder-extracellular matrix
(UBM) for the repair and reconstruction of diseased esophageal tissue.
Porcine-derived UBM represents an acellular biodegradable scaffold material
that supports cell attachment, migration, proliferation, differentiation, and
tissue remodeling. The hydrated form of single sheets of UBM and other ECMs
have shown excellent remodeling capabilities in both preclinical animal studies
and human clinical studies for applications unrelated to the gastrointestinal
tract. We propose to conduct three studies. Study #1 will establish
manufacturing methods for a multilaminate sheet of UBM that has defined
mechanical properties sufficient for esophageal repair. Study #2 will evaluate
the ability of a multilaminate UBM sheet to support primary esophageal
epithelial cell growth in vitro. Study #3 will utilize the prototype
multilaminate UBM device in a preliminary dog study in which a full
circumference segmental esophageal defect will be repaired. Currently, there
are no viable options for a biomaterial to replace esophageal tissue.
Esophageal stricture, and lack of esophageal motility are serious limitations
to existing biomaterial alternatives for this application. As location of
autologous stomach or bowel account for a majority of existing surgical
techniques for the repair or reconstruction of segments of the esophagus at the
present time. Successful completion of the three specific aims defined for this
Phase I project will provide the necessary information to decide whether or not
this UBM scaffold should be evaluated further as a biomaterial for esophageal
repair. Each objective/specific aim has well-defined endpoints and criteria for
success. An experienced and knowledgeable research team will conduct the
proposed studies and time line for the proposed work is provided. This
technology provides an innovative tissue engineering approach in a medical
field with significant unmet needs.
PROPOSED COMMERCIAL APPLICATION:
Congenital and acquired abnormalities of the esophagus present surgical challenges with
extremely limited options. Morbidity associated with surgical procedures is significant. Stricture
of the esophagus following either injury or replacement of damaged tissue by existing
biomaterials is a significant problem. Esophageal adenocarcinoma has increased in incidence
by 350% since the mid-1970's. Since this is a clinical area with virtually no biomaterial options,
the successful completion of this SBIR application addresses a significant unmet clinical need.

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

US Flag An Official Website of the United States Government