#Medtech #Stocks in
the News; Sigyn Therapeutics (OTC: $SIGY) Reports Results of Pilot Study to
Address Inflammatory CytoVesicles; @Sigyn_inc
SAN DIEGO CA, January 7, 2021 -- (Investorideas.com Newswire) Medical Therapeutic technology
stock news - Sigyn Therapeutics, Inc. (OTCMarkets: SIGY) , a medical technology company whose focus is the
treatment of life-threatening inflammatory conditions precipitated by Cytokine
Storm Syndrome (the Cytokine Storm), today announced the results of an in
vitro pilot study that successfully modeled the ability of Sigyn Therapy™
to address CytoVesicles that transport inflammatory cytokine cargos in the
bloodstream.
Read this news, featuring SIGY in full at https://www.investorideas.com/news/2021/biotech/01071Sigyn-Inflammatory-CytoVesicles.asp
Cytokine Storm Syndrome is an excessive
response of the immune system that is induced by infectious and non-infectious
conditions. A hallmark indicator of Cytokine Storm Syndrome is the excessive or
uncontrolled release of pro-inflammatory cytokines, which can lead to multiple
organ failure and cause death. The annual
market opportunity to address Cytokine Storm related indications exceeds $20
billion and includes sepsis, the most common cause of hospital deaths
worldwide. Virus-induced Cytokine Storm
Syndrome is a leading cause of death resulting from severe SARS-CoV-2
(COVID-19) infections.
Sigyn Therapy is a proprietary blood
purification technology designed to overcome the limitations of previous drug
and device candidates to treat acute inflammatory conditions. Incorporated within Sigyn Therapy is a
cocktail of adsorbent components with unique binding and capture
characteristics to optimize the broad-spectrum depletion of inflammatory
targets from the bloodstream. These targets include pro-inflammatory cytokines,
endotoxin and CytoVesicles (extracellular vesicles that transport inflammatory
cytokine cargos) that participate in concert with freely circulating cytokines
to further escalate the Cytokine Storm.
CytoVesicles are an important yet previously elusive target as they can
be 20-60 times larger than cytokines themselves.
In the in vitro pilot study, 104nm
liposomes were utilized as a model system to assess the ability of Sigyn
Therapy’s adsorbent components to deplete CytoVesicles from human blood
plasma. After a two-hour interaction
with Sigyn’s adsorbent components, liposome concentrations in human blood
plasma were reduced ~90%. Previously
published studies have validated liposomes as a model for the isolation of extracellular vesicles from blood based on
the similarity of their size and structural characteristics.
“When we designed Sigyn Therapy, we
envisioned a device that could be broadly deployed by the medical community,
yet also have expansive first-in-industry capabilities that offer to improve
patient outcomes,” stated Jim Joyce, Chairman and CEO of Sigyn Therapeutics.
“When considering our previous report that Sigyn Therapy™ clears both endotoxin
and inflammatory cytokines from human blood plasma, the observation from our
CytoVesicle pilot study further reinforces the potential for our vision to
become a therapeutic reality.”
Sigyn Therapy is a single-use device designed
for use on the established infrastructure of dialysis and CRRT machines already
located in hospitals and clinics worldwide. On
December 1, 2020, the Company reported the results of an in vitro study
that validated the ability of Sigyn Therapy to simultaneously reduce 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 from each of these studies
will be incorporated into an Investigational Device Exemption (IDE) that Sigyn
Therapeutics plans to submit to the United States Food and Drug Administration
(FDA) in 2021.
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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