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

在美国，每年有200万例剖腹手术，腹疝是常见的 10-30%的患者出现并发症。2006年，美国每例疝气手术的平均成本为 ~ 15，899美元，相当于每年~ 30 - 90亿美元。10年腹壁疝复发率为32- 63%。 美国每年销售的疝补片约为13亿美元。随着病态肥胖人群的增加 随着人口的增加，预计疝形成也会显著增加，使其成为主要的医疗负担。 疝用缝合线和补片修补，但这些装置由于机械张力而失败。有 五种常见的机械失效模式：缝线断裂、缝线结散开、缝线撕裂补片， 补片撕裂和缝线撕裂组织。T型线网格克服了所有五种失效模式。 项目PI，霍华德莱文森，医学博士，杜克整形和重建外科医生发明了T线疝 在杜克大学机械工程主席Ken Gall博士和前 北卡罗来纳州州立大学蔡司非织造技术研究所所长乔恩·鲁斯特博士说。DBMA，Inc. 从杜克和北卡罗来纳州生物技术中心筹集了超过24.5万美元的赠款资金， T型线疝补片走向商业化。通过我们多学科的努力， 律师、法规事务专家、CMO Secant Medical/Sanavita、CRO NAMSA、医疗器械 管理人员，工程师和外科医生，我们已经创建了一个全面的技术开发时间轴， 一家分拆出来的公司，深蓝医疗进步（DBMA，Inc.），来实现我们的目标DBMA，Inc.有 在产品开发中取得了重要的里程碑，包括一项已公布的专利，关键的意见领袖 支持、完成体外（提交给Hernia的手稿）和体内的概念验证和安全性研究， DBMA，Inc.在重要的国家会议，PSRC，ASRM和乔治敦AWR工作 研讨会第一阶段申请的目的是完成我们的下两个关键具体目标， 发展计划：具体目标1. NAMSA和特定目标2的生物相容性试验。6个月GLP 杜克的猪研究，以确定安全性和性能。完成DBMA，Inc.本提案中的努力 将是我们的II类器械获得510（k）许可所需工作的2/3。这两项任务都是 之前通过2015年7月向FDA提交的预申请与FDA达成一致，并且是可行的， 在预算内。完成这些任务后，DBMA，Inc.将提交第二阶段STTR申请， 将DBMA开发为业务实体，并执行其他开发工作。DBMA，Inc.也将在一个 强大的地位，以确保私人投资，无论是从大型天使，如杜克天使网络，比尔 美敦力前董事长霍金斯或与巴德、卡地纳健康、约翰逊& 约翰逊，库克医疗，Acellity，爱惜康，和美敦力，他们都对该技术感兴趣，根据 NDA，并积极讨论与DBMA的潜在关系。

Abstract 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.