Recent US health statistics indicate that approximately 840,000 patients in the 40-65 age range suffer from activity limiting hip OA, but only about 15% of this group choose to undergo hip replacement surgery. This low percentage is attributed to the shortened projected lifetime of hip implants for active patients and the subsequent need for revision surgeries and overall decreased effectiveness. Left without viable surgical alternatives, these young, active patients are left to manage their pain through pharmaceuticals or nutraceuticals. To address the need of this young active patient population, Cytex Therapeutics, Inc. is developing an implant that can be used to replace the diseased cartilage of the femoral head. The goal is to stave off a traditional total hip arthroplasty procedure, provide pain relief, and restore an active lifestyle, which would solve a clinical problem for which no good solutions currently exist. We have made outstanding progress in our pre-clinical research and showed that our approach using biomimetic scaffolds produce implants with excellent functional properties similar to those of native cartilage. Our unique, bilayered implant replicates the load-bearing properties of the respective tissues and spatially controls tissue development, resulting in an implant that immediately restores function while promoting long-term tissue regeneration. Eventually, the native tissues re-form and the implant degrades, leaving the patient with a living, biologic tissue replacement. The core technology of the cartilage resurfacing implant employees a 3D microwoven textile bonded to a porous osteoconductive substrate to create a high-performance, precisely engineered implant. The implant can be manufactured to match complex geometries and custom curvatures found in the hip joint and is 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 two-fold: 1) to address manufacturing and scale up issues with our technology and establish a manufacturing plan, and 2) to develop a regulatory plan for our implant technology. As the development of both manufacturing and regulatory plans are significant impediments to commercialization, our goal is to use this Commercialization Readiness Pilot Program to start to address these hurdles while completing our preclinical work. The development of these plans will be beneficial for our commercialization plans but also valuable to potential investors as we will have responded to many significant regulatory and manufacturing issues by the completion of these aims.
Patients in the 40-65 age range suffering from activity limiting hip arthritis rarely choose to undergo hip replacement surgery because of the high risks associated with premature implant failure due to an active lifestyle. Cytex Therapeutics, Inc. has developed a high-performance, precisely engineered implant for this patient population, and the goal of this proposal is to produce strategic regulatory and manufacturing plans to support the commercialization of this novel cartilage-resurfacing hip implant, providing a clinical solution where none currently exists.