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

• 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
• 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

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/总结