SBIR Phase I: Bioinert Viscoelastic Gels as Diseased Soft Tissue Lubricants

该SBIR I期项目旨在证明首个用于治疗骨关节炎的可注射凝胶的技术可行性。骨关节炎是一种身体关节疾病，影响着超过2700万美国人，拟议的活动将降低专有凝胶技术的风险，以保证继续开发治疗骨关节炎的医疗设备。该产品是一种生物启发的聚合物凝胶溶液，通过注射到关节中进行给药，它将润滑、缓冲和保护关节软骨免受磨损，从而减缓骨关节炎的进展。在成功完成该项目后，该公司的目标是完成所需的临床前和临床研究，以获得拟议活动产生的产品的监管批准。从这个项目中，将获得对身体-生物材料相互作用的更深入的基本理解，使工程师，临床医生和最终患者受益。该产品的预期商业成功将在产品开发完成之前和之后创造就业机会。由于关节疼痛是导致错过工作、残疾和生活质量普遍下降的主要原因之一，该项目的成功完成将为开发一种治疗骨关节炎的有效医疗器械奠定基础。该项目的技术创新在于获得专利的合成技术和组织成分-保护性凝胶溶液以治疗浓度保留在关节囊中的时间显著长于当前可注射凝胶的保留时间。在美国批准用于治疗骨关节炎的所有可注射粘弹性剂均由透明质酸组成，透明质酸是一种生物聚合物，在注射后迅速降解;相比之下，本项目中的产品使用合成的生物启发聚合物，其抗降解并保持有效的粘弹性四个月，而当前产品的粘弹性在一周后降解。该项目的第一个目标是通过放射性标记的生物分布研究，确定注射到啮齿动物膝盖后凝胶在整个身体中的分布，以证明100%清除出动物，并且在任何组织或器官中没有蓄积。该项目的第二个目标是开发材料加工技术和注射器灌装方案，用于将凝胶配制成最终产品形式，并确保符合产品性能和安全性质量标准。这些目标的完成将允许在FDA合规设计控制下生产产品，用于本项目后进行的关键大型动物研究，沿着完成正式的生物相容性试验，以提交给FDA，以寻求批准用于人类临床试验。该奖项反映了NSF的法定使命，并已被认为是值得通过评估使用基金会的智力价值和更广泛的支持。影响审查标准。

This SBIR Phase I project aims to demonstrate the technical feasibility of a first-of-its-kind injectable gel for treating osteoarthritis. Osteoarthritis, a disease of the body's joints, affects greater than 27 million Americans, and the proposed activity will de-risk the proprietary gel technology to warrant continued development of a medical device for treating osteoarthritis. The product is a bioinspired polymer gel solution, to be administered by injection into the joint, which will lubricate, cushion, and protect the joint's cartilage from wear, and thereby slow the progression of osteoarthritis. Upon successful completion of this project, the company aims to complete the preclinical and clinical studies required to gain regulatory approval for the product emanating from the proposed activity. From this project, a deeper fundamental understanding of body-biomaterial interactions will be gained, benefiting engineers, clinicians, and ultimately patients. The anticipated commercial success of this product will result in job creation both before and after completion of product development. As joint pain is one of the leading causes of missed work, disability, and general depreciation of quality of life, successful completion of the proposed high-technical-risk project will lay the foundation for development of an impactful medical device which will treat the highly prevalent disease osteoarthritis.The innovation of this project's technology lies in the patented synthetic techniques and composition of a tissue-protective gel solution that remains in the joint capsule at therapeutic concentrations for significantly longer than current injectable gels remain. All injectable viscoelastics approved in the United States for treating osteoarthritis are comprised of hyaluronic acid, a biopolymer which degrades rapidly upon injection; in contrast, the product in this project uses a synthetic, bioinspired polymer which resists degradation and maintains effective viscoelastic properties for four months, whereas current products' viscoelasticity is degraded after one week. The project's first objective will, through a radiolabeled biodistribution study, ascertain the gel's distribution throughout the body following injection into rodent knees, to demonstrate 100% clearance out of the animal and no accumulation within any tissues or organs. The project's second objective will develop the material processing techniques and syringe filling protocol for formulating the gel into its final product form and ensuring product performance and safety specifications are met. Completion of these objectives will allow product to be made under FDA-compliant Design Control for a pivotal large animal study to be conducted following this project, along with completion of formal biocompatibility testing for submission to FDA to seek approval for a First-in-Human clinical trial.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.