Histogenics is regenerative medicine company focused on developing products in the musculoskeletal segment of the marketplace. NeoCart, the primary candidate, utilizes various aspects of the company’s regenerative medicine platform to develop tissue implants intended to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee. Histogenics has no other products that are approved for sale in the United States. It is currently in Phase 3, studying cartilage defects in the knees of 245 patients under a Special Protocol Assessment with the FDA.
Based on recent publications, there is an estimated 1,000,000 knee arthroscopies performed each year in the United States, and cartilage damage is likely to be identified in over 60% of those knee arthroscopies. Also there is an estimated 750,000 knee replacements performed in the U.S. annually.
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The goal of the regenerative medicine platform is to develop a strong pipeline. Histogenics hopes the positive clinical data seen in treating cartilage damage of the knee with NeoCart will be applicable to other joints such as the ankle, hip and shoulder.
Histogenics is financing the Phase 3 clinical trial with funds raised from private financing activities. It intends to use the proceeds from this offering to finance the trial through the expected completion of enrollment in the first half of 2016.
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