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|Histogenics Announces Publication of Data From Collagen and Chondrocyte 3-D Bioprinting Study|
– Findings Augment Growing Body of Information to Support the Manufacture of Current and Next-Generation NeoCart® Implants –
“Our collaboration with
The results from the work have augmented Histogenics’ overall characterization of the gelation properties of collagen. In addition, findings from the studies are supportive of previous work demonstrating that: (i) collagen hydrogels containing riboflavin have increased mechanics compared to collagen hydrogels without riboflavin; (ii) the kinetics of collagen gelation and gel mechanics are pH dependent; and (iii) printability improves with increased levels of collagen concentration. Additionally, when measuring cell viability of chondrocytes, intermediate riboflavin concentration may be preferred for cell viability while pH variations did not have an effect on chondrocyte viability.
“The development of collagen-based bioinks for printing is an important frontier in cartilage tissue engineering and we are excited have collaborated with
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. 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. NeoCart is the only product in development or on the market with this unique one-year primary superiority endpoint.
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