A Novel Bioresorbable Bone Adhesive Used to Fixate Cranial Flaps and Reduce Infection Rates

一种新型生物可吸收骨粘合剂，​​用于固定颅骨瓣并降低感染率

• 批准号: 10010631
• 负责人: Brian Hess
• 金额: $ 132.55万
• 依托单位: REVBIO, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010631
• 关键词: Acute; Address; Adhesives; Advanced Development; Anatomy; Animal Experimentation; Animal Model; Animals; Antibiotics; Biocompatible Materials; Brain; Cadaver; Calcium; Canis familiaris; Cephalic; Cerebral Abscesses; Cerebrospinal Fluid; Clinic; Clinical Research; Clinical Trials; Clip; Control Groups; Cosmetics; Coupled; Craniotomy; Data; Debridement; Development; Devices; Dura Mater; Effectiveness; Evaluation; Excision; Extravasation; Funding; Goals; Government; Head; Health Care Costs; Healthcare Systems; Human; Infection; Injectable; Lead; Literature; Manufacturer Name; Measures; Medical; Medical Device; Meningitis; Metals; Modeling; Morbidity - disease rate; Neurosurgeon; Operative Surgical Procedures; Pain; Patient-Focused Outcomes; Patients; Persons; Phase; Positioning Attribute; Postoperative Period; Procedures; Production; Repeat Surgery; Reporting; Risk Factors; Secure; Serious Adverse Event; Sheep; Small Business Innovation Research Grant; Spinal; Steroids; Subdural Empyema; Surgeon; Surgical Flaps; System; Time; Titanium; Water; base; biomaterial compatibility; bone; bone healing; clinical translation; clinically relevant; cohesion; cost; cranium; design; effectiveness evaluation; improved; infection rate; infection risk; innovation; instrument; novel; operation; pressure; prevent; prototype; sample fixation; seal; skull base; standard of care; success; tool; wound

Project Abstract LaunchPad Medical (“LPM”) is a medical device company that was established to commercialize the novel Tetranite® (“TN”) wet-field bone adhesive product. TN is a synthetic, injectable, adhesive, cohesive, self-setting, and bioresorbable calcium-based biomaterial for cranial use. The current state of the art materials for cranial flap fixation are titanium screws and plates or clips; however, hardware fixation results in many complications that often necessitate reoperation. These complications include hardware loosening over time, skull disfiguration, cerebrospinal fluid (“CSF”) leaks, and infections. The instruments used to remove the bone flap and access the brain during craniotomy inevitably create a gap (“kerf”) between the bone flap and the surrounding cranial bone. Titanium fixation does not fill this gap. The result is an open channel for CSF leaks, treatment for which almost doubles the cost of the original operation. CSF leaks are also associated with an increased infection risk of 13x. TN can fill the kerf to provide a water-tight seal to block CSF leakage, create a better cosmetic contour, and fixate the bone flap, alleviating the need for metal in the cranium. There is currently no material in the medical device market that addresses all of this issues simultaneously. Results from a 2-year pivotal animal study have demonstrated TN’s effectiveness in fixating the flap and providing better bone healing than conventional hardware fixation. Consequently, the use of this innovative biomaterial has the potential to improve patient outcomes and reduce the overall cost of healthcare. The goal of the Direct-to-Phase II SBIR project is to develop a novel delivery kit for TN that will allow for its eventual introduction to the clinic as well as to demonstrate that CSF leak after craniotomy can be addressed by TN. Funding will be used to (1) design and develop production-ready prototypes of a cranial flap fixation kit that comprises a cranial flap positioning tool and a semi-automated mixing and delivery system, (2) validate with surgeons in a mock surgical cadaver trial the effective use of the cranial flap fixation kit, and (3) conduct an acute animal study using the delivery system to prove that TN provides a seal that prevents CSF leakage and withstands bacterial colonization in the relevant clinical time window. Building on successful animal studies already conducted, this Direct-to-Phase II project will enable a complete adhesive-based cranial flap solution to advance into human clinical trials via the submission of an IDE to FDA. Clinical study evidence will allow market entry of a single product for cranial flap fixation that has the potential to significantly reduce CSF leaks and infection rates for the 210,000 patients annually undergoing craniotomy. LaunchPad Medical Abstract 1 of 1

项目摘要 LaunchPad Medical（“LPM”）是一家医疗器械公司，其成立目的是将新型药物商业化 Tetranite® (“TN”) 湿场骨粘合剂产品是一种合成、可注射、粘合、内聚、自固化、 和用于颅骨的可生物吸收的钙基生物材料当前最先进的颅骨瓣材料。 固定是钛螺钉和板或夹子；然而，硬件固定会导致许多并发症 这些并发症通常需要再次手术，包括随着时间的推移硬件松动、颅骨变形、 脑脊液（“CSF”）渗漏和感染 用于移除骨瓣并进入脑脊液的器械。 开颅手术期间，大脑不可避免地会在骨瓣和周围颅骨之间产生间隙（“切口”）。 钛固定不能填补这一空白，其结果是导致脑脊液泄漏的开放通道，几乎无法进行治疗。 脑脊液漏出的成本增加了一倍，同时感染风险增加了 13 倍。 TN 可以填充切口，提供防水密封，阻止脑脊液渗漏，打造更好的外观轮廓，并且 固定骨瓣，减轻颅骨内金属的需要，目前医学上还没有这种材料。 一项可同时解决所有这些问题的市场设备已获得为期 2 年的关键动物研究结果。 TN 在固定皮瓣方面的有效性已得到证实，并且比传统方法提供更好的骨愈合 经过检查，这种创新生物材料的使用有可能改善患者的情况。 结果并降低医疗保健的总体成本。 Direct-to Phase II SBIR 项目的目标是开发一种新型的 TN 交付套件，使其能够 最终引入临床并证明开颅手术后脑脊液漏可以通过以下方法解决 TN. 资金将用于 (1) 设计和开发可立即投入生产的颅骨瓣固定套件原型。 包括颅瓣定位工具和半自动混合和输送系统，(2) 验证 外科医生在模拟手术尸体试验中有效使用颅瓣固定套件，以及 (3) 进行急性手术 使用该输送系统进行的动物研究证明 TN 提供的密封可防止脑脊液渗漏 在相关的临床时间窗口内抵抗细菌定植。 在已经进行的成功动物研究的基础上，这个直接进入第二阶段的项目将能够实现完整的 基于粘合剂的颅骨瓣解决方案通过向 FDA 提交 IDE 进入人体临床试验。 临床研究证据将允许用于颅瓣固定的单一产品进入市场，该产品有潜力 显着降低每年 210,000 名接受开颅手术的患者的脑脊液漏和感染率。 LaunchPad 医学摘要第 1 篇（共 1 篇）