SBIR Phase I: A Biosynthetic Composite Implant for Joint Resurfacing

This Small Business Innovation Research (SBIR) Phase I project purposes to develop a new treatment for osteoarthritis, a debilitating joint disease characterized by significant tissue degeneration within the joint, significant pain, and loss of function. At the end stage of this disease, the only option is a total joint replacement using artificial materials, which is not appropriate for younger patients. The overall goal of this work is to utilize principles of regenerative medicine and engineering to develop a joint resurfacing implant to replace and regenerate the entire damaged articulating joint surfaces. Particularly, this project will study the infusion of an ultra-tough gel into an anatomically shaped, high-performance, three-dimensionally woven implant. The potential benefit of this technology is that it avoids costly and extensive culture time by improving the immediate properties of the scaffold to mimic the properties of native tissues. The research objectives are to develop these composite implants to match that of the native tissue using a variety of formulations and then examine their ability to integrate into living tissues over long-term culture. The broader impact/commercial potential of this project addresses the estimated $65B cost to the economy imparted each year by hip arthritis. After a patient fails conservative treatment, the standard surgical treatment is a total joint replacement, where the joint is replaced by artificial materials. Unfortunately, artificial joints have a lifespan of only 15-20 years and then typically require a revision surgery, which is complicated by high failure rates, making them a poor option for young patients with end-stage osteoarthritis. There are currently approximately 1 million patients younger than 65 with activity limiting hip osteoarthritis with no effective surgical therapies to treat them. Therefore, even conservative estimates of the addressable market size for the proposed product are calculated at $164 million today. This is expected to increase to at least $563 million in 2018 due to projected growth of the target demographic, market penetration, and an increase in the price of hip prostheses. If efficacy is demonstrated, it stands to reason that this technology, which satisfies an unmet clinical need, would be rapidly adopted and would therefore have tremendous clinical and economic impact in the US as well as enriching understanding of joint resurfacing technology in the scientific community.