– Findings Augment Growing Body of Information to Support the Manufacture of Current and Next-Generation NeoCart ® Implants – – 3-D Bioprinting May Enable More Efficient Production of Next Generation NeoCart Implants –
WALTHAM, Mass., July 11, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq: HSGX ), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced the online publication in the Journal Biofabrication of a peer-reviewed publication entitled Correlating Rheological Properties and Printability of Collagen Bioinks: the Effects of Riboflavin Photocrosslinking and pH . The publication analyzes the effects of variables on type I collagen bioinks both with and without chondrocytes, or cartilage cells, including riboflavin crosslinking and pH before, during and after gelation and directly correlated these findings to printability. The work was done as part of a sponsored research agreement between Histogenics and Dr. Lawrence Bonassar, Professor at Cornell University (Cornell) in the Meinig School of Biomedical Engineering and the Sibley School of Mechanical and Aerospace Engineering. The lead author is Nicole Diamantides of Cornell with support from Louis Wang and Dr. Bonassar of Cornell, Tylar Pruiksma of the University of Utah, and Caroline Dugopolski, Stephen Kennedy, Sonya Shortkroff and Joseph Siemiatkoski of Histogenics. The objectives of the study were to determine how crosslinking and pH variations affect the cell viability of chondrocytes and the mechanics, gelation kinetics and printability of collagen bioinks and to determine the extent to which collagen rheological properties can be used to predict the printability of collagen bioinks with and without chondrocytes.
“Our collaboration with Cornell is an important element of our overall research and development strategy to further characterize the raw materials and cellular therapy platform underlying NeoCart. As a result of the valuable work done under the collaboration, we continue to generate novel, exciting data that we can use to support the optimization of the process used to produce NeoCart, as well as for future development of other product candidates in the NeoCart platform,” said Stephen Kennedy, Chief Technology Officer of Histogenics. “The data generated in this study provide us with valuable information related to the properties of collagen, a key element of the current generation of NeoCart implants,” continued Mr. Kennedy.
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 Histogenics on this project,” stated Dr. Bonassar. “The data from this work demonstrate how we can optimize bioink formulations and use photocrosslinkers to achieve better print resolution while maintaining high cell viability. These are important steps towards producing functional cartilage by tissue printing,” continued Dr. Bonassar.
About NeoCart
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. Histogenics is conducting the trial under a SPA the FDA and expects to report topline data in the third quarter of 2018. NeoCart is not approved for sale in any jurisdiction. For more information, please visit www.neocartimplant.com .
About Histogenics Corporation
Histogenics is a leading regenerative medicine company developing and commercializing novel tissue therapies that may offer more rapid and durable recoveries for patients with pain and loss of function due to musculoskeletal conditions. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering and bioadhesives to create tissue ex-vivo . Histogenics’ first investigational product candidate, NeoCart is designed to treat cartilage defects in the knee and is currently in Phase 3 clinical development. 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. 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. There are more than 500,000 or more knee cartilage procedures in the United States each year, with many healthy active adults avoiding treatment as they seek other alternatives. Left untreated, even a small cartilage defect can expand in size and progress to debilitating osteoarthritis, ultimately necessitating a joint replacement procedure. Osteoarthritis is more common in adults over the age of 50, but the condition and precursors of the condition can be observed much earlier, and cartilage damage is believed to be one of the leading contributors of this disease. For more information, please visit www.histogenics.com .
Forward-Looking Statements
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 December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov . In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.
There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
