Company Profile
Novel Solutions for Cartilage Repair
Leveraging Regenerative Medicine Innovation with
the Ultimate Goal of Improving Patient’s Lives
About Histogenics
Histogenics is a regenerative medicine company focused on developing
and commercializing products in the musculoskeletal segment of the
marketplace. Our regenerative medicine platform combines expertise in
cell processing, scaffolding, tissue engineering, bioadhesives and growth
factors to provide solutions that can be utilized individually or in concert to
treat musculoskeletal-related conditions. Our first product candidate,
NeoCart®, leverages our platform to provide an innovative treatment in the
orthopaedic space, specifically cartilage damage in the knee.
Company History
Platform & Products
Histogenics was incorporated in 2000 with an initial focus of
Our regenerative medicine platform is comprised of innovative
developing products that meaningfully improve the lives of
bioengineering, advanced proprietary materials sciences as
patients with defects in cartilage and joints. In May 2011, the
well as molecular and cellular biology technologies that can be
company acquired ProChon Biotech, Ltd. (ProChon), a
utilized individually or in a variety of combinations.
privately-owned biotechnology company based in Israel, which
enabled a synthesis of products, technology and materials
science by establishing a robust scientific and technology
platform targeting tissue repair solutions.
marketing
and
commercializing
products in the musculoskeletal segment of the marketplace.
The company is building its core technology platform and
plans to expand its clinical products’ therapeutic applications
to develop new and innovative solutions for musculoskeletal
conditions. Histogenics leverages a combination of the latest
advances in molecular biology and proprietary materials
sciences to create products designed to help improve patient
outcomes.
NeoCart, is an investigational cartilage implant produced using
trial were conducted in the United States. The Phase 2 clinical
Histogenics’ goal is to become a leading regenerative medicine
developing,
create a potential treatment for cartilage damage in the knee.
a patient's own healthy cartage cells. A Phase 1 and 2 clinical
Company Vision
company
Our first product candidate, NeoCart, leverages our platform to
trial compared NeoCart to the standard-of-care microfracture,
and met its objectives for safety and for improvement in pain
and function. NeoCart is currently enrolling a Phase 3 clinical
trial in the United States under an approved Special Protocol
Assessment. Information about the study is available on
http://www.clinicaltrials.gov (search term: ‘NeoCart’).
NeoCart is a registered trademark of Histogenics
Caution: New Biologic. NeoCart is limited by federal law to
investigational use only and is not available for sale.
For additional inquiries, please email us at
[email protected] or call us at 781.547.7900.
www.histogenics.com
Copyright © 2014 - Histogenics, Inc. - All rights reserved
Company Profile
Regenerative Medicine
such as general wear over time. Unlike other tissues in the body,
Regenerative medicine is a rapidly developing, interdisciplinary
joint cartilage has no innate ability to repair itself, making any
field that is transforming healthcare by translating fundamental
injury permanent. Left untreated, even a small chondral defect can
science into a variety of products and solutions aimed at repairing,
expand in size and progress to debilitating arthritis, ultimately
regenerating or replacing function loss caused by injury, disease
necessitating a joint replacement procedure.
or aging. Regenerative medicine technologies
Knee Cartilage Injury
encompass a variety of therapeutic
approaches, including tissue engineering,
We estimate that, based in part on
cell-based therapies, gene therapy,
historical growth rates reflected in
small molecules and biologics, stem
a 2011 article in The Journal of Bone
cells and biobanking. Any combination
and Joint Surgery, over 1 million knee
of these technologies may be used to
arthroscopies are performed on
harness or stimulate the body's innate
an annual basis in the U.S. in
healing ability in order to treat a wide
skeletally mature adults, and based
range of ailments, including musculoskeletal-related
conditions, cardio- and peripheral vascular diseases, neurological
disorders, stroke, non-healing wounds and ocular diseases.
on a 2007 article published in The
Knee,
more
than
60%
of
those
arthroscopies may reveal cartilage damage.
Cartilage damage is a leading cause of osteoarthritis, a chronic
Musculoskeletal Conditions
condition in which cartilage breaks down, and the condition most
Musculoskeletal conditions, comprised of injuries to or diseases of
responsible for the estimated 750,000 knee replacements
bones, cartilage, joints, ligaments, muscles, nerves, skin or
performed in the United States annually.
tendons, are the most common health problem in the United
States and are a leading cause of disability and healthcare
expenditure according to The Burden of Musculoskeletal Diseases in
the United States, a 2011 publication of a coalition of professional
organizations including the American Academy of Orthopaedic
Surgeons. Based on the commercial introduction of new products
and
expanded
applications
of
approved
products,
the
musculoskeletal and orthopedics/spine segment of the market
(which includes cartilage, bone, nerves, muscles,
tendons and ligaments), is projected to reach
approximately $13 billion worldwide by
2015 according to a 2011 report issued
Debridement and microfracture procedures are the most
frequently performed surgical procedures for treatment of
cartilage damage. Debridement does not repair cartilage damage,
as its only goal is to improve symptoms. Microfracture is
considered the current standard of care for severe chondral
defects due to its simplicity, symptom improvement in the
short-term for many patients, its safety profile and the lack of
other alternatives. However, microfracture has been unsuccessful
in reliably solving the underlying problem of cartilage damage
because the repair tissue formed by the procedure is incapable of
withstanding the normal shock and shear forces that joint
by MedMarket Diligence.
cartilage sustains. Microfracture is also associated with numerous
Cartilage Injury
long-term patient benefits and extended patient recovery.
Joint, or articular, cartilage covers the
Autologous Chondrocyte Implantation (ACI) and osteochondral
ends of bones and allows for joints to
grafting have drawbacks and limitations similar to those affecting
glide smoothly with minimal friction.
debridement and microfracture, and also are associated with
Cartilage damage, or chondral defects, can
be caused by acute trauma, such as a bad fall
or sports-related injury, or by repetitive trauma,
other drawbacks and limitations: modest efficacy, limited
technically demanding surgeries and negative safety profiles.
Caution: New Biologic. NeoCart is limited by federal law to
investigational use only and is not available for sale.
For additional inquiries, please email us at
[email protected] or call us at 781.547.7900.
www.histogenics.com
Copyright © 2014 - Histogenics, Inc. - All rights reserved