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Histogenics Announces Publication of Biomechanical and Structural Data From Human Engineered Cartilage Testing
– Data demonstrate Histogenics’ Tissue Engineered Cartilage Constructs Exhibit Mechanical Properties Approaching Native Human Cartilage as Early as Three Weeks in Culture and Prior to Implantation –
– First Study to Use Three Mechanical Tests to Examine and Understand the Performance of Repaired Cartilage in Accordance with FDA Guidance –
The objective of the study was to understand the complex mechanical behavior, function and changes that occur in human chondrocyte seeded collagen constructs during in vitro culture using multiple mechanical tests, which measure the compressive, frictional and shear properties of the constructs. This study was the first to examine the measurement of all three of these properties in human chondrocyte seeded constructs, and is intended to respond to
“We are excited to continue building our scientific understanding of the hyaline cartilage like properties of our tissue engineered product, NeoCart, and intend to use the data from these tests to support the Biologics License Application for NeoCart,” said
While all mechanical properties of human, tissue engineered, cartilage constructs nominally improved with time, frictional properties approached native values by three weeks and compressive properties approached native values by seven weeks. The results of the study suggest that in vitro cartilage constructs, or tissue implants, produced using a process that is designed to mimic that of NeoCart® exhibited mechanical properties prior to implantation approaching such properties of native cartilage. Specifically, the results of the study indicate that a combination of cells, scaffold and engineering play an important role in the development of tissue engineered-cartilage implants, such as NeoCart, and the maturation of such implants, leads to improved biological and mechanical properties. Together, these attributes may enable the early response and repair of focal cartilage lesions and the results of this study are consistent with data seen in patients in the Phase 1 and 2 clinical trials of NeoCart.
“Cartilage is a unique and difficult tissue to repair or regenerate. This challenge is evident from the many approaches to cartilage repair that include cells and scaffolds,” stated Dr.
The full peer-reviewed publication will be available in the Investor Relations section of the
NeoCart is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells. The patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to organize and function like cartilage cells. 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. NeoCart is currently in a Phase 3 clinical trial that 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.
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended
There can be no assurance that the actual results or developments anticipated by
All written and verbal forward-looking statements attributable to
Contact: Investor Relations Tel: +1 (781) 547-7909 InvestorRelations@histogenics.com