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

一种新型疝气网可改善锚点固定并防止疝气形成

基本信息

批准号：
9344908
负责人：
David Ruppert
金额：
$ 22.48万
依托单位：
DEEP BLUE MEDICAL ADVANCES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-15 至 2018-09-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9344908
关键词：
Adhesives Affect Area Autopsy Biotechnology Budgets Businesses Chairperson Clinic Clinical Trials Complication Coughing Data Development Development Plans Devices Doctor of Philosophy Engineering Equipment and Supplies Failure Family suidae Fascia Female Funding Goals Grant Health Healthcare Healthcare Industry Hernia Ileus Implant In Vitro Institutes Investments Ischemia Laparotomy Lateral Lawyers Legal patent Licensing Manuscripts Mechanical Stress Mechanics Medical Medical Device Morbid Obesity Motion Multi-Institutional Clinical Trial Muscle North Carolina Notification Obesity Patients Performance Perioperative Peripheral Phase Plant Roots Plasticizers Polypropylenes Population Positioning Attribute Preparation Privatization Publishing Randomized Recurrence Regulatory Affairs Risk Assessment Safety Secure Small Business Technology Transfer Research Sneezing Solvents Stress Surface Surgeon Surgical Mesh Surgical incisions Surgical sutures Technology Tendon structure Testing TimeLine Tissues Toxicology Trees United States Universities Ventral Hernia Vomiting Weight Work abdominal wall base biomaterial compatibility commercialization cooking cost design exhaustion high risk improved in vivo innovation interest intraperitoneal male meetings multidisciplinary novel operation preclinical development prevent product development prototype reconstruction repaired research and development safety study safety testing sample fixation scale up soft tissue standard of care symposium technology development tissue reconstruction

项目摘要

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.

摘要在美国每年进行200万种腹腔运动，腹侧疝气经常 10-30％的患者并发症。 2006年美国每个疝气操作的平均成本/患者是〜$ 15,899，每年约为3-9亿美元。十年的腹性疝复发率为32-63％。疝网中每年售出约1.3B美元。随着病态肥胖的增加人口，疝气形成也有望显着增加，使其成为主要的医疗保健负担。疝气用缝合线和网状修复，但由于机械张力而失败。有五种常见的机械故障模式：缝合线破裂，缝合结的拆开，缝合线撕裂网眼，网状撕裂，缝合线撕裂组织。 T线网格克服了所有五个故障模式。 PI项目，医学博士霍华德·莱文森（Howard Levinson），杜克大学塑料和重建外科医生发明了T线疝气网格在杜克大学，肯·加尔（Ken Gall）博士的机械工程主席的支持下，并以前北卡罗来纳州立大学（NC State University）乔恩·鲁斯特（Jon Rust）博士的无编织技术学院主席。 DBMA，Inc。已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 Tline疝气朝向商业化。通过我们的多学科工作律师，监管事务专家，CMO SCANT医疗/Sanavita，CRO NAMSA，医疗设备高管，工程师和外科医生，我们创建了一个全面的技术开发时间表和一家纺纱公司Deep Blue Medical Advances（DBMA，Inc。），以实现我们的目标。 DBMA，Inc。拥有在产品开发中实现了关键的里程碑，包括已发表的专利，关键意见负责人在体外的支持，概念证明和安全研究（手稿提交给疝气）和体内，并介绍了DBMA，Inc。在主要国家会议，PSRC，ASRM和Georgetown AWR上工作座谈会。 I阶段I应用的目的是完成我们的下两个关键特定目标发展计划：特定目的1。使用NAMSA和特定目标进行生物相容性测试。杜克大学的猪研究以建立安全性和性能。 DBMA，Inc。完成此提案的努力将为我们II类设备获得510（k）间隙的必要工作的2/3。这两个任务都是以前，通过2015年7月向FDA提出前往FDA的FDA同意，是可行的，并且在预算之内。完成这些任务后，DBMA，Inc。将提交II期STTR申请以进一步开发DBMA作为业务实体并执行其他开发工作。 DBMA，Inc。也将在强大的立场可以从任何一个大天使（例如杜克天使网络）等大天使那里获得私人投资霍金斯（Hawkins）是Medtronic的前董事长，或Bard，Cardinal Health，Johnson＆等战略合作伙伴约翰逊，库克医学，艾克尔蒂，埃蒂康和麦德里奇，所有这些人都对这项技术感兴趣， NDA，并积极讨论与DBMA的潜在关系。