#MedTech #Stocks in
the News: Sigyn Therapeutics (OTC: $SIGY) Reports Simultaneous Clearance of
Endotoxin and Inflammatory Cytokines From Human Blood Plasma; @Sigyn_inc
SAN DIEGO, CA,
December 2, 2020 / -(Investorideas.com newswire) Breaking Medical Tech/ therapeutic
technology stock news -- Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), a medical technology company focused on treating life-threatening
inflammatory conditions, today announced the completion of an in vitro study
that demonstrated the ability of Sigyn Therapy™ to clear both endotoxin and
inflammatory cytokines from human blood plasma.
Read this news featuring SIGY in full
at https://www.investorideas.com/news/2020/biotech/12021Sigyn-Therapeutics-Endotoxin-Cytokines.asp
Sigyn Therapy is a novel blood purification
technology designed to mitigate cytokine storm syndrome, which precipitates a
wide-range of life-threatening conditions, including sepsis, the most common
cause of hospital deaths. Virus induced
cytokine storm syndrome is associated with high mortality and currently is a
leading cause of SARS-CoV-2 (COVID-19) deaths.
Sigyn Therapy is a single-use device designed for use on the established
infrastructure of dialysis and CRRT machines located in hospitals and clinics
worldwide.
In the in vitro
study, Sigyn Therapy simultaneously reduced the presence of endotoxin and
relevant pro-inflammatory cytokines, which included Interleukin-1 Beta (IL-1B),
Interleukin-6 (IL-6) and Tumor Necrosis Factor alpha (TNF-a). Endotoxin
(lipopolysaccharide or LPS) is a potent mediator implicated in the pathogenesis
of sepsis and septic shock. The
dysregulated over-production of IL-1B, IL-6 and TNF-a can lead to organ failure
and cause death.
An objective of
the study was to rebalance elevated cytokine levels and optimize the
elimination of endotoxin from human blood plasma. The study was conducted in
triplicate over four-hour time periods with a pediatric version of Sigyn
Therapy. Average reduction of endotoxin
load peaked at 83% during the studies. The average reduction of IL-1B was 69%,
IL-6 reduction was 59% and TNF-a reduction was 57% during the four-hour
studies. The resulting data will be
incorporated into an Investigational Device Exemption (IDE) that Sigyn plans to
submit to the United States Food and Drug Administration (FDA) in 2021.
“The simultaneous
clearance of endotoxin and inflammatory cytokines is a significant milestone
that reinforces the potential of Sigyn Therapy to overcome the limitations of
industry pioneering devices that are currently deployed to treat
life-threatening inflammatory conditions,” stated Jim Joyce, Chairman and CEO
of Sigyn Therapeutics.
At present, the
CytoSorb device from CytoSorbents Corporation and the Toraymyxin device from
Toray Industries are market cleared and broadly administered to treat a
wide-range of life-threatening inflammatory conditions outside of the United
States. In regards to mechanism, the Toraymyxin device has a high specificity
to bind circulating endotoxin, but does not address inflammatory cytokines.
Conversely, the CytoSorb device depletes inflammatory cytokines from
circulation, but does not address endotoxin.
In addition to
reporting the dual clearance of endotoxin and inflammatory cytokines, the
Company further disclosed that it plans to evaluate the ability of Sigyn
Therapy to address other inflammatory targets, including CytoVesicles that
transport inflammatory cytokine cargos throughout the bloodstream. The Company believes that Sigyn Therapy is
the first therapeutic candidate to target circulating CytoVesicles.
About
Sigyn Therapeutics
Sigyn Therapeutics™ is a development-stage
therapeutic technology company headquartered in San Diego, California USA. Our
focus is directed toward a significant unmet need in global health; the
treatment of life-threatening inflammatory conditions that are precipitated by
Cytokine Storm Syndrome and not addressed with an approved therapy. Our mission
is to save lives.
Sigyn Therapy™ is a novel blood purification
technology designed to mitigate cytokine storm syndrome through the
broad-spectrum depletion of inflammatory targets from the bloodstream. Cytokine
storm syndrome is the hallmark of sepsis, which is the most common cause of
in-hospital deaths and claims more lives each year than all forms of cancer
combined. Virus induced cytokine storm (VICS) is associated with high mortality
and is a leading cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic opportunities
include, but are not limited to bacteria induced cytokine storm (BICS), acute
respiratory distress syndrome (ARDS) and acute forms of liver failure, such as
hepatic encephalopathy.
To
learn more, visit www.SigynTherapeutics.com or www.SigynTherapy.com
Cautionary
Note Regarding Forward-Looking Statements
This press release contains forward-looking
statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks
and uncertainties. All statements contained in this press release are
forward-looking statements within the meaning of The Private Securities
Litigation Reform Act of 1995. The words “could,” “will,” “plan,” “intend,”
“anticipate,” “approximate,” “expect,” “potential,” or the negative of these
terms or other similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among others,
statements about Sigyn’s future financial performance, the impact of management
changes, any proposed organizational restructuring, results of operations,
capital resources to fund operations; statements about Sigyn’s expectations regarding
the capitalization, resources and ownership structure of the combined company;
statements about the potential benefits of the transaction; the expected
completion and timing of the transaction and other information relating to the
transaction; and any other statements other than statements of historical fact.
Actual results or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that Sigyn makes due
to a number of important factors, including (i) the risk that the transaction
may not be completed in a timely manner or at all, which may adversely affect
Sigyn’s business and the price of the common stock of Sigyn, (ii) the failure
to satisfy of the conditions to the consummation of the transaction, (iii) the
occurrence of any event, change or other circumstance that could give rise to
the termination of the merger agreement, (iv) risks related to the ability to
realize the anticipated benefits of the transaction, including the risk that the
businesses will not be integrated successfully, (v) the effect of the
announcement or pendency of the transaction on Sigyn’s business relationships,
operating results and business generally, (vi) risks that the proposed
transaction disrupts current plans and operations, (vii) risks related to the
combined entity’s ability to up-list to a national securities exchange, (viii)
risks related to the combined entity’s access to existing capital and
fundraising prospects to fund its ongoing operations, (ix) risks related to
diverting management’s attention from Sigyn’s ongoing business operations, (x)
other business effects, including the effects of industry, market, economic,
political or regulatory conditions, future exchange and interest rates, and
changes in tax and other laws, regulations, rates and policies, and (xi) risks
related to an inability to manufacture Sigyn Therapy, risks related to the
clinical advancement of Sigyn Therapy with regulatory agencies, and no
assurance that Sigyn Therapy will be proven to be a safe and efficacious
treatment for any condition. The forward-looking statements in this press
release represent Sigyn’s views as of the date of this press release. Sigyn
anticipates that subsequent events and developments may cause its views to
change. However, while it may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any obligation to do so.
You should, therefore, not rely on these forward-looking statements as
representing Sigyn’s views as of any date subsequent to the date of this press
release.
Contact
Sigyn Therapeutics, Inc.
Jim Joyce
Chairman, CEO
(619) 368-2000
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