Deep Blue Medical Advances, Inc. — Department of Health and Human Services STTR Phase I: 300

Description

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