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|Histogenics Announces Publication of Additional Biomechanical Data From Human Engineered Cartilage Testing|
– Data Demonstrate the Importance of Generating Extracellular Matrix During Ex-Vivo Manufacturing of Cartilage Cell Therapy –
– Ex-vivo Production of Extracellular Matrix is Critical to Biomechanical Competence and May Enable Earlier Return to Function After Treatment –
– Presence of Extracellular Matrix at Time of Implantation Improves Biomechanical Competence of Cartilage Cell Therapy Compared to Therapies with Only Cells and Scaffold –
The goal of the study was to understand how the deposition of glycosaminoglycans (GAG), a component of the extracellular matrix (ECM), influences the microscale compressive properties of tissue engineered cartilage that was produced using a lab-scale process designed to mimic that of NeoCart®. The compressive properties were specifically analyzed by looking at localized scaffold buckling.
“Our collaboration with
The compressive properties of the tissue implants improve with increased processing time, as ECM is deposited in the scaffold pores and are highly correlated to the GAG content of the constructs. Scaffolds seeded with chondrocyte cells absent significant extracellular matrix and GAG deposition have a strong tendency to buckle or collapse, resulting in sub-optimal biomechanical properties of such cartilage tissue implants. The reported results are consistent with earlier work demonstrating that in vitro cartilage constructs, or tissue implants, produced using a process that is designed to mimic that of NeoCart exhibit mechanical properties prior to implantation approaching such properties of native cartilage. Together, these attributes may enable the early response and repair of focal cartilage lesions and these findings are consistent with data seen in patients in the Phase 1 and 2 clinical trials of NeoCart.
“Developing cartilage tissue implants with appropriate mechanical properties has been a challenge for many years. It is clear that deposition of ECM improves mechanical performance, but the mechanism behind this improvement has not been clear,” 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. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage. 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. As a result, NeoCart is the only product in development or on the market with a one-year primary superiority endpoint as compared to the standard of care. 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 at one year post implantation 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 generating the data from the 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