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

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.