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

摘要在美国，每年有200万例开腹手术，腹股沟是一种常见病。 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，相当于每年约30-90亿美元。腹股沟疝十年复发率为32-63%。 在美国，每年大约有13亿美元的疝气网片销售。随着病态肥胖症人数的增加 在人口方面，预计疝气的形成也将显著增加，使其成为主要的医疗负担。 疝气可以用缝线和网片修补，但这些装置由于机械张力而失败。确实有 五种常见的机械破坏模式：缝合断裂、缝合结解开、缝合撕破网眼、 撕开网眼，缝合撕裂组织。T形网眼克服了所有五种故障模式。 项目名为Pi，Howard Levinson，医学博士，杜克大学的整形和重建外科医生，发明了T型线疝气 与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布技术研究所所长，乔恩·拉斯特博士。DBMA公司 已经从杜克大学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，以推动 T型线疝气朝着商业化方向发展。通过我们的多学科合作， 律师、监管事务专家、CMO Secant Medical/Sanavita、CRO NAMSA、医疗设备 管理人员、工程师和外科医生，我们已经创建了全面的技术开发时间表和 一个衍生公司，深蓝医疗先进(DBMA，Inc.)，以实现我们的目标。DBMA，Inc.拥有 在产品开发方面取得了关键里程碑，包括已公布的专利、关键意见领袖 支持，完成体外(提交给疝气)和体内的概念验证和安全性研究， 并在主要国家会议、PSRC、ASRM和乔治敦AWR上介绍了DBMA，Inc.的工作 研讨会。此第一阶段应用程序的目的是完成我们的 发展计划：具体目标1.与NAMSA进行生物相容性测试，具体目标2.6个月的GLP 猪在杜克大学学习，以确定安全性和性能。完成本建议书中的DBMA，Inc.工作 将是为我们的II类设备实现510(K)许可所需工作的2/3。这两项任务都已经完成 之前在2015年7月通过预先提交给FDA与FDA达成协议，并且是可行的和 在预算之内。在完成这些任务后，DBMA，Inc.将提交第二阶段STTR申请，以进一步 将DBMA作为一个业务实体进行开发，并执行其他开发工作。DBMA，Inc.也将在 强势地位，可获得来自Duke Angel Network、Bill等大天使的私人投资 霍金斯，美敦力前董事长，或巴德，红衣主教健康，强生等战略合作伙伴 Johnson、Cook Medical、Acellity、ethicon和Medtronic，他们都对这项技术感兴趣， NDA，并积极与DBMA讨论潜在的关系。

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.