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A Novel Hernia Mesh to Improve Anchor Point Fixation and Prevent Hernia Formation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41GM117657-01A1
Agency Tracking Number: R41GM117657
Amount: $224,837.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 300
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-15
Award End Date (Contract End Date): 2018-09-14
Small Business Information
Research Triangle Park, NC 27709-0003
United States
DUNS: 079752359
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (919) 323-0260
Business Contact
Phone: (919) 558-1207
Research Institution
2200 W MAIN ST, SUITE 820
DURHAM, NC 27705-4673
United States

 Nonprofit college or university

Abstract Two million laparotomies are performed annually in the U S with ventral hernia being a frequent
complication in of patients The average cost patient for each hernia operation in the U S in was
$ which amounts to $ billion annually The ten year ventral hernia recurrence rate is
There are $ B in hernia meshes sold annually in the United States With increases in the morbidly obese
population hernia formation is expected to significantly increase as well making it a major healthcare burden
Hernias are repaired with suture and mesh but these devices fail because of mechanical tension There are
five common mechanical failure modes suture breaking suture knot unraveling suture tearing through mesh
mesh ripping and suture tearing through tissue The T line mesh overcomes all five failure modes
The project PI Howard Levinson MD a Duke Plastic and Reconstructive Surgeon invented the T line hernia
mesh with support from the Chairman of Mechanical Engineering at Duke Ken Gall PhD and the previous
chairman of the Zeiss Institute of Non Woven technologies at NC State University Jon Rust PhD DBMA Inc
have raised over $ k in grant funding from Duke and the North Carolina Biotechnology Center to advance
the T line hernia mesh towards commercialization Through our multi disciplinary efforts working with
attorneys regulatory affairs experts the CMO Secant Medical Sanavita the CRO NAMSA medical device
executives engineers and surgeons we have created a comprehensive technology development timeline and
a spin out company Deep Blue Medical Advances DBMA Inc to achieve our goal DBMA Inc have
achieved critical milestones in the product development including a published patent key opinion leader
support completion of proof of concept and safety studies in vitro manuscript submitted to Hernia and in vivo
and presented DBMA Inc work at major national meetings PSRC ASRM and Georgetown AWR
Symposium The purpose of this Phase I application is to complete the next two key Specific Aims in our
development plan Specific Aim biocompatibility testing with NAMSA and Specific Aim a month GLP
swine study at Duke to establish safety and performance The completion of DBMA Inc efforts in this proposal
will be of the necessary work to achieve k clearance for our class II device Both tasks have been
previously agreed upon with the FDA through a pre submission to the FDA in July and are feasible and
within budget Upon completion of these tasks DBMA Inc will submit a Phase II STTR application to further
develop DBMA as a business entity and perform additional development work DBMA Inc will also be in a
strong position to secure private investment from either large Angels such as the Duke Angel Network Bill
Hawkins the former chairman of Medtronic or a strategic partner such as Bard Cardinal Health Johnson andamp
Johnson Cook Medical Acellity Ethicon and Medtronic all of whom are interested in the technology under
NDA and actively discussing potential relationships with DBMA Project Narrative
Hernia occurrence and recurrence is a major medical problem that affects hundreds of
thousands of patients per year in the United States and costs billions of dollars annually Hernia
mesh and suture are commonly used in repairs but they often fail because of mechanical stress
DBMA Inc proposes to develop a novel hernia mesh to overcome the most common
mechanical failure modes of mesh and suture

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

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