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Histogenics (HSGX), ups enrollment numbers

October 24, 2016 10:02am

HSGX had enrolled 183, of the 245 patients required to complete enrollment of its ongoing NeoCart P3 clinical trial. HSGX is DOWN -$0.06 to $2.71 – BUY on weakness

This trial is being conducted under a Special Protocol Assessment (SPA) with the FDA. The enrollment strategies continue to result in increased patient enrollment in our ongoing NeoCart P3 clinical trial.

The Bottom Line: With enrollment approximately 75% complete and tracking ahead of expectations, HSGX are now counting down the number of patients required to complete enrollment having recently completed a financing aimed at funding HSGX through its top-line data read-out in mid-2018.

HSGX is DOWN in the morning session -$0.06 to $2.71 – BUY on weakness

The P3 clinical trial is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults ages 18 to 59 and to show superiority of NeoCart against the current standard of care, microfracture.

· NeoCart is a tissue-engineered cartilage implant created from a patient’s own cells. The patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to function like native cartilage.

· Before NeoCart is shipped to the surgeon for implantation, the cell and scaffold construct undergoes a bioengineering process that is designed to mimic a joint so that the implant, upon placement in the knee with a proprietary bioadhesive, is primed to begin functioning like healthy cartilage. Histogenics believes that these attributes may offer patients a more rapid recovery and a more durable treatment option, if approved, than other products and procedures, either on the market or in development.

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