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

这个SBIR一期项目旨在证明第一种治疗骨关节炎的注射凝胶的技术可行性。骨关节炎是一种人体关节疾病，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，以保证治疗骨关节炎的医疗设备的持续发展。该产品是一种生物激发的聚合物凝胶溶液，通过注射进入关节，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，公司的目标是完成临床前和临床研究，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层次的基本理解，这将使工程师、临床医生和最终的患者受益。该产品预期的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缺工、残疾和生活质量下降的主要原因之一，成功完成拟议的高技术风险项目将为开发一种有效的医疗设备奠定基础，该设备将治疗高度流行的骨关节炎疾病。该项目的技术创新在于专利合成技术和组织保护凝胶溶液的组成，该凝胶溶液在关节胶囊中以治疗浓度保留的时间比目前的注射凝胶保留的时间长得多。美国批准用于治疗骨关节炎的所有可注射粘弹性材料都由透明质酸组成，透明质酸是一种注射后迅速降解的生物聚合物；相比之下，该项目的产品使用了一种合成的生物激发聚合物，它可以抵抗降解，并保持有效的粘弹性长达四个月，而现有产品的粘弹性在一周后就会降解。该项目的第一个目标是通过放射性标记的生物分布研究，确定凝胶在注射到啮齿动物膝盖后在全身的分布，以证明100%清除动物并且在任何组织或器官内没有积累。该项目的第二个目标是开发材料加工技术和注射器填充方案，以使凝胶形成最终产品形式，并确保产品性能和安全规格得到满足。这些目标的完成将使产品符合FDA的设计控制，用于该项目之后进行的关键大型动物研究，同时完成正式的生物相容性测试，提交给FDA，寻求批准首次人体临床试验。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.