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

这个SBIR第一阶段项目旨在证明第一种用于治疗骨关节炎的可注射凝胶的技术可行性。骨关节炎是一种人体关节疾病，影响着2700多万美国人，拟议中的活动将降低专利凝胶技术的风险，以保证继续开发一种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，将润滑、缓冲和保护关节的软骨免受磨损，从而减缓骨关节炎的进展。在这个项目成功完成后，该公司的目标是完成所需的临床前和临床研究，以获得监管机构对拟议活动产生的产品的批准。从这个项目中，将获得对人体-生物材料相互作用的更深层次的基本理解，使工程师、临床医生和最终患者受益。这种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误工、残疾和生活质量普遍下降的主要原因之一，拟议的高技术风险项目的成功完成将为开发一种治疗这种高度流行的疾病骨关节炎的有效医疗设备奠定基础。该项目技术的创新在于专利合成技术和组织保护凝胶溶液的组合物，该凝胶溶液在治疗浓度下在关节胶囊中保留的时间远远长于目前的可注射凝胶。在美国被批准用于治疗骨关节炎的所有可注射粘弹性材料都含有透明质酸，这是一种注射后会迅速降解的生物聚合物；相比之下，该项目中的产品使用了一种人工合成的生物灵感聚合物，这种聚合物可以抵抗降解并在四个月内保持有效的粘弹性性能，而目前产品的粘弹性在一周后就会退化。该项目的第一个目标将通过放射性标记的生物分布研究，确定凝胶注射到啮齿动物膝盖后在全身的分布，以证明100%从动物体内清除，并且没有在任何组织或器官内蓄积。该项目的第二个目标将开发材料加工技术和注射器灌装方案，以将凝胶配制成最终产品形式，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能够在FDA合规的设计控制下制造，以便在该项目之后进行关键的大型动物研究，同时完成正式的生物兼容性测试，以提交给FDA，以寻求对首个人类临床试验的批准。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.