Joint repair continues to be a significant challenge that demands the use of innovative materials that can provide both mechanical and biological function. The I-Corps team is developing an electroactive scaffold that mimics both structural and electrical properties of the native extracellular matrix present during early cartilage development to repair articular cartilage defects. This biomaterial represents a different, cost-effective and simple approach to tapping into a biological mechanism for repairing damaged articular cartilage. The joint environment appears to be rich in mesenchymal progenitor cells, which have been isolated from the bone marrow, periosteum, synovial membrane and fluid, and from the articular cartilage itself. A regenerative approach for joint tissue repair could be the recruitment of resident endogenous stem cells to the site of damage and activation of the repair process. The electroactive scaffold is a synthetic material, piezoelectric polyvinylidine fluoride copolymer (FDA-approved material for suture applications), that is processed into a fibrous form. Fibrous scaffolds have a beneficial structural feature for cell adhesion and growth due to their large surface-to-volume and high aspect ratios resulting from the smallness of the diameter. The piezoelectric scaffold will actively restore function by recruiting endogenous stem cells to the site of damage, and provide the appropriate electromechanical cues to promote their growth and transformation into cartilage cells.
A significant number of Americans suffer from cartilage damage resulting from injury, or wear and tear. These lesions can significantly affect a person's quality of life and can progress to osteoarthritis (OA) that is disabling. Cartilage damage and related OA conditions are extremely costly. Surgical procedures to restore articular cartilage have not been able to restore a normal cartilaginous surface and have suffered from poor integration with the surrounding normal articular cartilage. Consequently, a growing unmet need exists for early reconstruction of cartilage damage with a reliable treatment method that facilitates the preservation of function as well as reduces the need for future reconstruction or total joint replacements. The piezeoelectric material will be developed into a medical device for use in large cartilage defects. The commercialization potential is strong as it does not require the sale and delivery of cells as part of the device and cost effective relative to other devices in development by industry.
Cartilage damage in joints, like the knee, is common as a result of injury or age. An estimated 49 million Americans suffer from cartilage damage resulting from injury, or wear and tear. Cartilage damage and related OA conditions cost the US $128 billion per year with an estimated $81 billion per year in direct medical costs and $47 billion per year in indirect costs from loss of wages and productivity. Surgical procedures to restore articular cartilage are costly, invasive, are not able to restore normal cartilaginous surface and have suffered from poor integration with the surrounding normal articular cartilage. Through the NSF I-Corps grant we conducted more than 100 customer discovery interviews with experts and stakeholders in the cartilage repair market to validate the hypotheses that (1) a growing unmet need exists for early reconstruction of cartilage damage, and (2) no reliable treatment method exists to facilitate the preservation of function as well as reduce the need for future reconstruction or total joint replacements. The customer discovery interviews with individuals in the cartilage repair market helped us validate the above hypotheses. Customers are in need of a simple, less demanding procedure, regrowth of normal hyaline cartilage, complete filling of the defect, and patient results that include complete pain relief, normal joint functionality for return to pre-injury activities, joint durability and longevity of repair. The NSF ICORPS program helped our team devise a business model for the commercialization of our technology. Presently, the startup company, BioRegenics,is partnering with New Jersey Institute of Technology (NJIT) in developing ElectroActive Scaffold (EAS), a synthetic surgical implant that mimics both the structural and electrical properties of the native extracellular matrix present during early cartilage development, to facilitate a natural repair process for articular cartilage defects with normal, functional hyaline cartilage. This technology represents a novel, cost-effective and simple approach for tapping into an existing biological process for repairing damaged articular cartilage. EAS has strong commercialization potential, as a medical device, for use in large cartilage defects, requires no cellular components and will be cost effective compared to other devices in development.
