Meniscal injuries represent one of the most common intra-articular knee injuries, resulting in over 750,000 surgical procedures in the United States annually. Removal of the torn tissue, known as meniscectomy, typicallyprovides short-term relief from pain, discomfort, and instability, but alters the joint's mechanics, leaving theunderlying cartilage susceptible to long-term osteoarthritis. There is currently no FDA-approved implant for totalmeniscus replacement. Our approach is to replace torn or degenerated menisci with a mechanically functionalreplacement implant, MeniscoFixTM, capable of being slowly absorbed while remodeling into functional,chondroprotective neo-meniscal tissue.The goal of this Phase I SBIR project is to optimize the design of the MeniscoFix⢠implant technology for clinicaluse in both the medial and lateral meniscus, addressing anatomical, biomechanical, and functional requirements.Aim #1: Optimization of MeniscoFixTM designs for use in both the medial and lateral meniscus.SolidWorks with finite element analysis (FEA) will be used to design and screen fiber reinforcement patterns formedial meniscus and lateral meniscus implants, which differ in anatomy, size, shape, and root attachment sites.Based on FEA simulations, designs which optimally satisfy anatomical and biomechanical design requirementswill be selected for subsequent manufacturing and preliminary design verification including tensile, compressive,viscoelastic, and cyclic testing per ASTM F3223-17.Aim #2: Addition of radial fibers to reduce risk of implant extrusion. Prototypes are currently made bystacking multiple 2-dimensional (X-Y) fiber reinforcement patterns using a CNC machine. We will now evaluatevarious fiber reinforcement patterns in the radial or "Z-direction' to potentially improve biomechanical propertiesand reduce the risk of implant extrusion after implantation.Aim #3: Mechanical reinforcement of the implant "tail region' required for surgical fixation. The design ofthe tail region of the implant will be improved to provide for rigid intra-osseous surgical fixation while maintainingimplant integrity, reducing risks of loosening or breakage at the tibial attachment sites.Preliminary design validation studies will also be performed to ensure MeniscoFix⢠satisfies the needs of theend user. Key Opinion Leaders in Orthopaedic Surgery will evaluate usability characteristics of MeniscoFixTMby performing arthroscopically-assisted meniscus replacement procedures in human cadaver knees.Successful achievement of these SBIR project milestones will further de-risk the technology and improveopportunities to partner with established Orthopaedic medical device manufacturers. The ultimate goal is toprovide Orthopaedic surgeons with a novel, safe, and effective treatment option to restore and maintain qualityof life in patients suffering from irreparable meniscal injuries or post-meniscectomy syndrome.
Public Health Relevance Statement: NovoPedics is continuing the pre-clinical optimization of MeniscoFix, a novel total meniscus replacement implant,
to fill an unmet need in the clinical treatments for the severely injured meniscus of the knee. The implant has
the potential to relieve pain, restore mobility, and delay or prevent development of post-traumatic osteoarthritis.
The feasibility of MeniscoFix has been established in previous pre-clinical studies; in the present project, we will
optimize implant design and manufacturing processes, as well as perform preliminary verification/validation
studies, towards commercialization of a full product line of MeniscoFix implants for replacement of either the
medial or lateral meniscus of the knee.
Project Terms: <2-dimensional>
