Commercialization of an Improved Treatment of Extremity Fractures Using a Regenerative Bone Adhesive to Accelerate Bone Healing in Aging Patients

使用再生骨粘合剂加速老年患者骨愈合的四肢骨折改进治疗方法的商业化

基本信息

批准号：
10822079
负责人：
Brian Hess
金额：
$ 174.67万
依托单位：
REVBIO, INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-30 至 2026-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10822079
关键词：
Acceleration Address Adhesives Adverse event Age Aging Anesthesia procedures Animals Award Biological Cadaver Carpal Tunnel Syndrome Clinical Investigator Clinical Research Clinical Trials Complex Regional Pain Syndromes Complication Defect Development Distal Elderly Electroplating Enrollment Equation Event Failure Fatigue Filler Formulation Fracture Fracture Fixation Funding Goals Good Clinical Practice Grant Guidelines Human Incidence Infection Injury Institution Intervention Life Limb structure Lower Extremity Market Research Metals Methods Mission Modeling Multi-Institutional Clinical Trial National Institute on Aging Operative Surgical Procedures Orthopedics Oryctolagus cuniculus Outcome Study Patients Performance Periodicity Persons Phase Population Process Quality of life Radius Fractures Recurrence Regional Anatomy Reporting Research Risk Rupture Safety Sampling Second Look Surgery Sheep Site Small Business Innovation Research Grant Specific qualifier value Sterility Sterilization Surgeon Syndrome System Techniques Tendon structure Testing Training Trauma Upper Extremity Validation Work biomaterial compatibility bone bone fracture repair bone healing clinical research site commercialization cost design verification experience falls first-in-human fragility fracture healing image guided implant design improved irritation mortality novel patient population pre-clinical research preclinical development preclinical study prevent primary endpoint product development programs radiological imaging regenerative safety study sample fixation standard of care standing height usability validation studies

Acceleration Address Adhesives Adverse event Age Aging Anesthesia procedures Animals Award Biological Cadaver Carpal Tunnel Syndrome Clinical Investigator Clinical Research Clinical Trials Complex Regional Pain Syndromes Complication Defect Development Distal Elderly Electroplating Enrollment Equation Event Failure Fatigue Filler Formulation Fracture Fracture Fixation Funding Goals Good Clinical Practice Grant Guidelines Human Incidence Infection Injury Institution Intervention Life Limb structure Lower Extremity Market Research Metals Methods Mission Modeling Multi-Institutional Clinical Trial National Institute on Aging Operative Surgical Procedures Orthopedics Oryctolagus cuniculus Outcome Study Patients Performance Periodicity Persons Phase Population Process Quality of life Radius Fractures Recurrence Regional Anatomy Reporting Research Risk Rupture Safety Sampling Second Look Surgery Sheep Site Small Business Innovation Research Grant Specific qualifier value Sterility Sterilization Surgeon Syndrome System Techniques Tendon structure Testing Training Trauma Upper Extremity Validation Work biomaterial compatibility bone bone fracture repair bone healing clinical research site commercialization cost design verification experience falls first-in-human fragility fracture healing image guided implant design improved irritation mortality novel patient population pre-clinical research preclinical development preclinical study prevent primary endpoint product development programs radiological imaging regenerative safety study sample fixation standard of care standing height usability validation studies

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项目摘要

Project Abstract/Summary In the U.S., about 2.1 million people experience a fragility fracture each year. This number is expected to double or triple by 2040 as the population ages. Injuries in the upper and lower extremities equate to more than 40% of fragility fractures, and experiencing a prior fracture is associated with an 86% increased risk of recurrence. Falls from standing height and other low-energy trauma account for 87% of all orthopedic fractures among the elderly. External fixation, percutaneous pinning, and open reduction internal fixation with locking plates are interventions that are currently being used to treat extremity fractures. Despite advances in surgical technique and implant design, nonunion, malunion, and hardware failure continue to remain a significant cause of revision surgery in the elderly. Complication rates as high as 36% have been reported and involve onset of carpal tunnel syndrome, complex regional pain syndrome, tendon irritation and rupture, and deep infection. To address this problem, RevBio developed Tetranite® (TN), a novel bone adhesive that can fill gaps in bone, fixate bone fragments, and accelerate healing through its osteoconductive effects. TN can be used as an adjunct to traditional hardware fixation to provide immediate load sharing between the metal plate and screw systems, and bone. It provides additional stability by enhancing fracture stabilization to achieve better healing and prevents hardware failure. It can also be injected percutaneously a standalone method of fixation providing an option to surgically treat fractures without the need for open reduction, metal hardware, or anesthesia. Proposed work to treat extremity fractures in the elderly will bridge off existing late-stage development of TN supported by a SBIR Phase II award from the National Institutes of Aging entitled, “Improved Treatment of Distal Radius Fractures Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive” (R44 AG060881- 02). This grant enabled formulation optimization and conduction of user validation studies with surgeons (Aim 1) and a pivotal animal study in sheep (Aim 2) to demonstrate safety and efficacy of TN. This project is focused on a specific indication to treat distal radius fractures; however, based on discussions with FDA and surgeons, the impact and value of the material could be expanded to a wider set of indications across all metaphyseal fractures in the upper and lower extremities for this same patient population. Therefore, this grant would provide additional funding to conduct market research and supplemental pre-clinical development costs to expand its use to these additional anatomic regions. This funding would also enable completion of biocompatibility, sterilization, packaging, and shelf-life validations to finish late-stage development, enabling RevBio to file an IDE, and execute a clinical study with TN as an adjunct to hardware. The overarching goal of this program is to build off successful Phase II research and to execute Aim 1 and Aim 2 to lead to product regulatory approval for commercialization. Long term, RevBio’s mission is to commercialize TN in order to provide surgeons with a novel product that will enhance fixation, accelerate healing, and reduce complications associated with extremity fractures in the elderly.

项目摘要/摘要在美国，每年约有210万人遭受脆弱性骨折。这个数字有望翻倍或到2040年的人口年龄三倍。上肢和下肢的伤害等于40％以上脆性骨折和先前的骨折与复发风险增加86％有关。瀑布从站立高度和其他低能创伤中占所有骨科骨折的87％。外部固定，经皮钉和用锁定板的开放还原内固定是干预措施目前正在用于治疗肢体骨折。尽管进步了手术技术和植入物设计，非工会，Malunion和硬件故障继续仍然是重大的修订手术原因较早的。报告的并发症发生率高达36％，涉及腕管综合征的发作，复杂的区域疼痛综合征，肌腱刺激和破裂以及深层感染。为了解决这个问题，Revbio开发了Tetranite®（TN），这是一种新型的骨粘合剂，可以填补骨骼的间隙，固定骨骼碎片，并通过其骨导电效应加速愈合。 TN可以用作辅助传统硬件固定，以在金属板和螺丝系统之间提供立即负载共享，和骨头。它通过增强断裂稳定以实现更好的治愈和防止硬件故障。它也可以经常注入一种独立的固定方法可以手术治疗骨折的选择，而无需开放式减少，金属硬件或麻醉。拟议的工作以治疗四肢分数，将弥合现有的TN后期发展由美国国家老化研究所的SBIR II阶段奖的支持，标题为“改进了远端的治疗使用图像引导的，经皮递送的新骨粘合剂的半径骨折”（R44 AG060881- 02）。这项赠款使公式优化和使用外科医生对用户验证研究进行了传导（AIM 1）以及一项绵羊的关键动物研究（AIM 2），以证明TN的安全性和效率。该项目的重点是治疗远端半径骨折的特定指示；但是，根据与FDA和外科医生的讨论材料的影响和价值可以扩展到所有形而上学骨折的广泛适应症在同一患者人群的上肢和下肢中。因此，这笔赠款将提供额外的资金以进行市场研究和补充临床前开发成本，以扩大其用途其他解剖区域。这笔资金还将使生物相容性，灭菌，包装和保质期验证以完成后期开发，使Revbio提交IDE并执行与TN作为硬件辅助的临床研究。该计划的总体目标是成功建立第二阶段的研究并执行AIM 1和AIM 2，以导致商业化的产品监管批准。从长远来看，Revbio的使命是将TN商业化，以便为外科医生提供一种新颖的产品增强固定，加速愈合并减少与肢体肢体分数相关的并发症。