SPARTA BIOMEDICAL INC
Approximately 900,000 people annually in the United States suffer from damage to the articular cartilage and subchondral bone, with the knee being the most commonly affected. Articular cartilage lesions have a limited intrinsic ability to heal and often result in osteoarthritis (OA). Progression to OA poses significant economic burden for the United States, totaling over $300 billion annually, and negatively impacting 54.4 million adults (23% of the population). Current strategies for cartilage restoration include bone marrow stimulation (microfracture) and autologous chondrocyte implantation (ACI). These methods have high failure rates (25-50% at 10 years), prolonged rehabilitation times (> 12 months), and show decreasing efficacy in patients older than 40-50 years of age.
Sparta Biomedical is developing the first-of-its kind osteochondral repair technology (SBM-01) for support the restoration of the cartilage-bone unit. This purpose-built technology is comprised of a novel biomimetic material possesses cartilage-like properties-- tension, compression, tribology, and fatigue. The patent-pending surface is combined with a uniquely designed base to promote efficient osseous attachment and stable fixation over the long-term. Sparta’s technology will be a significant advancement in the current surgical standard of care. It will result in substantial pain reduction, immediate weight bearing post-operatively, and full range ambulation.
Sparta has assembled a nationally recognized team of scientists, clinicians, orthopedic regulatory experts to develop SBM-01 rapidly and cost effectively. SBM-01's risk profile enables an efficient regulatory path. Furthermore, it is well positioned to obtain Breakthrough Device Designation from the US FDA.