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Development of a Novel Bio-Adhesive Mesh System for Abdominal Hernia Repair

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK120168-01
Agency Tracking Number: R41DK120168
Amount: $224,418.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 300
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-15
Award End Date (Contract End Date): 2020-08-31
Small Business Information
106 PLANTATION DR, Greenwood, SC, 29649-9534
DUNS: 964241173
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 KEVIN CHAMPAIGNE
 (864) 980-7100
 kevin@circabio.com
Business Contact
 KEVIN CHAMPAIGNE
Phone: (864) 980-7100
Email: kevin@circabio.com
Research Institution
 CLEMSON UNIVERSITY
 230 KAPPA STREET, STE. 200
CLEMSON, SC, 29634-0001
 Nonprofit college or university
Abstract
Development of a Novel Bio Adhesive Mesh System for Abdominal Hernia Repair Project Summary Abstract This project proposes the development of a novel mesh adhesive system for abdominal hernia repair utilizing surface modification of polymer surgical mesh to allow for improved tissue fixation with a poloxamine hydrogel adhesiveMore thanmillion Americans undergo hernia repair with surgical mesh each yearmost commonly with polypropylenePPmeshwith associated annual healthcare costs in excess of $billionDuring abdominal hernia repaira majority of surgical meshes are fixed to abdominal tissue by mechanical devicese gsuturesstaplestacksor tissue adhesivese gfibrin sealantcyanoacrylate based glueMechanical devices are difficult to employ laparoscopically and can cause substantial post operative painAs suchfixation with tissue adhesives has been attemptedparticularly for laparoscopic surgeriesHowevercyanoacrylate based glues leave brittle residues and have elevated toxicity when used on intra abdominal tissuesLikewisefibrin sealants do not provide immediate fixation between the mesh and tissuesand so in largerandgtcmhernia defectsadditional mechanical devices such as sutures are needed to prevent edge curling and mesh slippageTo address these shortcomingswe propose to evaluate the combined application of two patented Clemson University technologiesa bifunctional poloxamine hydrogel adhesive and a surface modification technique to improve the adhesive strength between the hydrogel adhesive and polymer surgical meshesThe proposed hydrogel adhesive is non toxic to cells in culture over aday degradation periodIt is biocompatible and safe as a tissue adhesive for treatment of small soft tissue woundseliciting a controlled inflammatory response in vivo without provoking unwanted tissue adhesions when used on intra abdominal tissuesAlthough it exhibits an adhesive strength exceedingkPa between tissues via mechanical interdigitation and covalent bond formation with tissue aminesthe adhesive strength when used on unmodified PP mesh is inadequateThereforea patented surface modification technique will be employed to provide a poly glycidyl methacrylatePGMAlayer grafted to human serum albuminHSAto form a three dimensional plastic albuminIn our initial tests of adhesive strengths for meshes attached to collagen sheets with the hydrogel adhesivethe modified PP mesh using PGMA HSA grafting resulted in significantly improved adhesive strength compared to unmodified meshesFurther development of our mesh adhesive system will enable grafting of autologous proteins derived from the patient s own blood onto PP surgical mesh at the time of surgerythereby avoiding the potential for immunological reactions to foreign proteins on the mesh surfaceThis approach ultimately provides a complete solution for suture less large hernia defect repair with immediate mesh fixation using our hydrogel adhesivewhich will limit post operative complications and hernia recurrence as part of a simplified laparoscopic procedure Development of a Novel Bio Adhesive Mesh System for Abdominal Hernia Repair Project Narrative The proposed project will enable abdominal hernia repair surgery to be performed laparoscopically with no mechanical fixationsuch as tacks or sutureswhich are difficult to use and often cause substantial postoperative painThrough the use of both a patentedbiocompatible tissue adhesive and a patented polymer surface modification technology to be applied to existing surgical mesh productsimproved adhesion of the hernia mesh to abdominal tissues can be achieved as part of a laparoscopically compatible application systemThis approach ultimately provides a complete solution for suture less large hernia defect repair with immediate mesh fixation using our hydrogel adhesivewhich will limit post operative complications and hernia recurrence as part of a less invasive surgical procedure

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

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