- Company Adds Additional Leader in Tissue
Engineering and Biomechanics -- Additional NeoCart® Biomechanical
Data Presented in Conjunction with Cornell University -
Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative
medicine company focused on developing and commercializing products
in the musculoskeletal space, announced today the addition of
Professor Lawrence Bonassar to its Scientific Advisory Board
(SAB). The SAB's mission is to provide strategic scientific
and technical oversight as Histogenics brings NeoCart through its
ongoing Phase 3 clinical trial, and seeks to expand its pipeline
with additional indications and next generation cartilage therapies
by leveraging its biomaterials manufacturing experience and cell
therapy technology platform.
Dr. Bonassar is a Professor at Cornell
University in the Meinig School of Biomedical Engineering and the
Sibley School of Mechanical and Aerospace Engineering. His
research focuses on cartilage biomechanics and tissue engineering,
with a goal of understanding structure-property relationships in
cartilage to elucidate mechanisms of disease and inform design of
tissue replacements. He has authored more than 160 peer reviewed
manuscripts, is an inventor on 11 patents and won several national
and international awards including the Hansjorg Wyss Research Award
at the World Forum for Spine Research. Prior to joining the faculty
at Cornell, Dr. Bonassar was an Assistant Professor in the Center
for Tissue Engineering at the University of Massachusetts Medical
School. He received his bachelor’s degree from the Departments of
Biomedical Engineering and Materials Science and Engineering from
the Johns Hopkins University and received both his masters and
doctoral degrees from the Department of Materials Science and
Engineering at MIT. Dr. Bonassar also completed postdoctoral
training in the Department of Orthopaedic Surgery at Massachusetts
General Hospital.
“We are pleased to have Dr. Bonassar join our
distinguished team of scientific advisors. Our Sponsored Research
Agreement with his lab at Cornell has been highly successful in
demonstrating the biomechanical competence of cartilage tissue
engineered using our NeoCart manufacturing technology. The
work we have done together has resulted in two presentations to
date, the first at the Orthopedic Research Society annual meeting
in March 2016 and a more recent presentation at the Biomedical
Engineering Society Annual Meeting in October 2016,” stated Stephen
Kennedy, Chief Technology Officer of Histogenics. “Dr.
Bonassar’s expertise in biomechanics and tissue engineering will be
invaluable to Histogenics as we advance NeoCart through our ongoing
Phase 3 clinical trial and prepare to file a biologics license
application with the FDA,” continued Mr. Kennedy.
Dr. Bonassar joins current SAB members
Dr. Kyriacos A. Athanasiou, PhD, Professor of
Biomedical Engineering and Orthopaedic Surgery, University of
California Davis; Dr. Charles Cooney, PhD,
Professor Emeritus, Massachusetts Institute of Technology;
Dr. Jennifer Elisseeff, PhD, Professor Biomedical
Engineering, Johns Hopkins University; Dr. Shuichi
Mizuno, PhD, Assistant Professor, Orthopedic Surgery,
Harvard Medical School and co-founder of Histogenics; Dr.
Lonnie Shea, PhD, Professor Biomedical Engineering,
University of Michigan; and Dr. R. Lane Smith,
PhD, Professor of Orthopedic Surgery, Stanford University School of
Medicine.
About NeoCart
NeoCart is a cartilage-like, tissue-engineered
implant created from a patient’s own cartilage cells that is
currently in Phase 3 clinical development. The ongoing 245
patient clinical trial 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. Histogenics is conducting the trial under a
Special Protocol Assessment with the U.S. Food and Drug
Administration and expects enrollment to be between 190 and 200
patients at the end of 2016 and to be complete by the end of the
second quarter of 2017. Histogenics designed and manufactures
NeoCart using a proprietary, ex vivo bioengineering process so that
each NeoCart implant is primed to begin functioning like healthy
cartilage upon implantation in the knee. Histogenics believes
that these attributes may offer patients a more rapid recovery and
a more durable treatment option, if approved, than other products
and procedures, either on the market or in development.
About Histogenics
Corporation
Histogenics is a leading regenerative medicine
company developing and commercializing products in the
musculoskeletal segment of the marketplace. Histogenics’
regenerative medicine platform combines expertise in cell
processing, scaffolding, tissue engineering, bioadhesives and
growth factors to provide solutions to treat
musculoskeletal-related conditions. Histogenics’ first
investigational product candidate, NeoCart®, is currently in Phase
3 clinical development. NeoCart is an autologous cell therapy
designed to treat cartilage defects in the knee using the patient’s
own cells. Knee cartilage defects represent a significant
opportunity in the United States, with an estimated 500,000 or more
applicable procedures each year. 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, characteristics not exhibited in
other current treatment options. 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; the sufficiency of Histogenics’ cash resources and the
availability of additional financing on commercially reasonable
terms; Histogenics’ ability to attract or retain key personnel; the
early stage of development of the technologies on which
Histogenics’ channel partnering agreement with Intrexon is based;
the additional expenses that Histogenics will incur in connection
with its exclusive channel collaboration agreement with Intrexon
Corporation 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, 2015 and
Quarterly Reports on Form 10-Q for the quarters ended March 31,
2016 and June 30, 2016, which are on file with the SEC and
available on the SEC’s website at www.sec.gov. Additional
factors may be set forth in those sections of Histogenics’
Quarterly Report on Form 10-Q for the quarter ending September 30,
2016, to be filed with the SEC in the fourth quarter of 2016.
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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