Two million laparotomies are performed annually in the U.S., with ventral hernia being a frequent complication in 10-30% of patients. The average cost/patient for each hernia operation in the U.S. in 2006 was ~ $15,899, which amounts to ~ $3-9 billion annually. The ten-year ventral hernia recurrence rate is 32-63%. There are ~$1.3B 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 $245k 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 1. biocompatibility testing with NAMSA, and Specific Aim 2. a 6 month GLP swine study at Duke to establish safety and performance. The completion of DBMA, Inc. efforts in this proposal will be 2/3 of the necessary work to achieve 510(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 2015 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 & Johnson, Cook Medical, Acellity, Ethicon, and Medtronic, all of whom are interested in the technology, under NDA, and actively discussing potential relationships with DBMA.
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.
| Ibrahim, Mohamed M; Poveromo, Luke P; Glisson, Richard R et al. (2018) Modifying hernia mesh design to improve device mechanical performance and promote tension-free repair. J Biomech 71:43-51 |
