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HSTO - Histogen Inc News Story

$0.793 -0.0  -2.1%

Last Trade - 24/09/21

Sector
Healthcare
Size
Micro Cap
Market Cap £24.2m
Enterprise Value £6.56m
Revenue £1.03m
Position in Universe 6262nd / 7172

Histogen Announces Initiation of HST 003 Phase 1/2 Trial for Knee Cartilage Regeneration

Wed 30th June, 2021 1:00pm
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SAN DIEGO, June 30, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO),
today announced the initiation of its Phase 1/2 clinical trial of HST 003 to
evaluate the safety and efficacy of human extracellular matrix (hECM:HST 003)
implanted within microfracture interstices and the cartilage defect in the
knee to regenerate hyaline cartilage in combination with a microfracture
procedure. Clinical sites participating in the trial include: OasisMD in San
Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in
Bethesda, MD.

“The initiation of the HST 003 clinical trial as a treatment for
regeneration of knee cartilage marks a major milestone for Histogen as we
focus on developing best in class orthopedic therapeutics with our novel
regenerative medicine platform technology,” said Richard W. Pascoe,
Histogen’s President and CEO.

About the HST 003 Trial 
This double-blind placebo-controlled trial is designed to evaluate the safety
and efficacy of hECM implanted within microfracture interstices and the
cartilage defect in the knee to regenerate hyaline cartilage in combination
with a microfracture procedure. Primary and secondary endpoints will include
safety assessments, MRI to evaluate cartilage regeneration, and Knee Injury
and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation
Committee (IKDC) scores to evaluate pain and joint function.

About HST 003
Histogen’s human extracellular matrix, or hECM, is intended for regenerating
hyaline cartilage for the treatment of articular cartilage defects with a
novel malleable scaffold that stimulates the body’s own stem cells. In
multiple preclinical models, HST 003 has been shown to regenerate mature
cartilage and well vascularized bone, indicating great therapeutic potential
in the sports medicine, spinal disc repair, orthopedic, and dental areas.
Studies conducted by outside experts have demonstrated that HST 003 is
anti-inflammatory, angiogenic, and can stimulate the growth of stem cells in
damaged areas to induce tissue regeneration. The most extensive in vivo work
in animals has focused on the regeneration of new hyaline cartilage and bone
in full thickness knee injuries.

About Histogen
Histogen Inc. is a clinical-stage therapeutics company focused on developing
potential first-in-class restorative therapeutics that ignite the body’s
natural process to repair and maintain healthy biological function.
Histogen’s innovative technology platform utilizes cell conditioned media
and extracellular matrix materials produced by hypoxia-induced multipotent
cells. Histogen’s proprietary, reproducible manufacturing process provides
targeted solutions across a broad range of therapeutic indications including
joint cartilage regeneration, spinal disk repair, dermal rejuvenation and hair
growth. For more information, please visit www.histogen.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
the “safe harbor” provisions of the Private Securities Litigation Reform
Act of 1995 and other Federal securities laws. For example, we are using
forward-looking statements when we discuss Histogen’s future operations and
its ability to successfully initiate and complete clinical trials, obtain
clinical trial data and achieve regulatory milestones and related timing,
including those related to enrollment of the Phase 1/2 clinical trial of HST
003 for regeneration of cartilage in the knee; the nature, strategy and focus
of Histogen’s business; and the development and commercial potential and
potential benefits of any of Histogen’s product candidates, including HST
003. Histogen may not actually achieve the plans, carry out the intentions or
meet the expectations or projections disclosed in the forward-looking
statements and you should not place undue reliance on these forward-looking
statements. Because such statements deal with future events and are based on
Histogen’s current expectations, they are subject to various risks and
uncertainties and actual results, performance or achievements of Histogen that
could differ materially from those described in or implied by the statements
in this press release, including: the uncertainties associated with the
clinical development and regulatory approval of Histogen’s product
candidates, including potential delays in the commencement, enrollment and
completion of clinical trials, such as the enrollment of the Phase 1/2
clinical trial of HST 003 for regeneration of cartilage in the knee; the
potential that earlier clinical trials and studies of Histogen’s product
candidates may not be predictive of future results; risks related to business
interruptions, including the outbreak of COVID-19 coronavirus, which could
seriously harm Histogen’s financial condition and increase its costs and
expenses; and the requirement for additional capital to continue to advance
these product candidates, which may not be available on favorable terms or at
all. The foregoing review of important factors that could cause actual events
to differ from expectations should not be construed as exhaustive and should
be read in conjunction with statements that are included herein and elsewhere,
including those risks discussed in Histogen’s filings with the Securities
and Exchange Commission. Except as otherwise required by law, Histogen
disclaims any intention or obligation to update or revise any forward-looking
statements, which speak only as of the date hereof, whether as a result of new
information, future events, or circumstances or otherwise.

CONTACT:

Susan A. Knudson
Executive Vice President & CFO 
Histogen Inc. 
ir@histogen.com


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