– 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 –
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.
Contact:
Investor Relations
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com
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