Osteoarthritis (OA) remains a significant source of significant pain and disability, affecting over 30 million adults with an economic burden of over $130 billion per year to the US. Joint replacement is a well-established procedure, but its finite life span makes this treatment unacceptable for younger or more active individuals, who often require additional revision surgeries as they age. Both complicated revision surgery and initial joint replacement carry progressively increasing morbidity and mortality as patient age increases, leaving few good cost-effective treatment options once the replacement wears out. Previous work at Cytex has focused on the development of a construct that addresses these concerns by using a 3D woven textile to create a high- performance, precisely engineered implant for treatment of large cartilage lesions. This 3D woven scaffold can function immediately after implantation, all while encouraging cell ingrowth, proliferation, and subsequent tissue development. Moreover, the implant replaces only the diseased portion of the joint surface, leaving native bone stock intact should future surgical interventions prove necessary. Commercialization of an efficacious cartilage resurfacing implant would have significant clinical impact for these patients with moderate to severe OA, providing a surgical repair option where none currently exist. We have made outstanding progress in pre-clinical large animal studies and showed that our approach using biomimetic scaffolds rapidly restores function to the joint and alleviates pain. Cytex?s cartilage resurfacing implants can be manufactured to match complex geometries and custom curvatures found in the hip and knee joints and are specifically designed for large arthritic lesions that are untreatable with current cartilage repair options. Because of the success we have seen when applying our technology in vivo in increasingly complex animal models, we are currently seeking investments to accelerate this technology to market while simultaneously pursuing follow-on funding through small business NIH mechanisms. To this end, the purpose of this proposal is to develop and validate manufacturing equipment and processes in compliance with cGMP standards to prepare for commercial production of our implant. As the design and establishment of manufacturing processes for novel technologies is a significant hurdle to win both third-party investment and regulatory approval, our goal is to use this Commercialization Readiness Pilot Program to address this impediment while completing our preclinical work. Successful completion of this work will position Cytex to accelerate its innovative technology towards a commercially available product line.
Patients in the 40-65 age range who suffer from activity limiting OA rarely choose to undergo joint replacement surgery due to the high risks associated with premature implant failure in young, active patients. The goal of this proposal is to develop the validated manufacturing processes needed to support the commercialization of Cytex?s novel cartilage-resurfacing implants, which can be used to replace diseased cartilage of the hip or knee, providing clinical solutions where none currently exist.
