SAN DIEGO, CA -- July 15, 2021 -- InvestorsHub NewsWire -- Sigyn
Therapeutics, Inc. (OTCMarkets:
SIGY), a medical technology company focused on the treatment of
sepsis and other life-threatening inflammatory conditions, today
announced the completion of a study that demonstrated the
broad-spectrum ability of Sigyn Therapy™ to eliminate hepatic
toxins from human blood plasma.
In the study, Sigyn Therapy depleted the circulating presence of
bile acid, bilirubin and ammonia, which are toxins commonly
associated with Hepatic Encephalopathy, a neurological disorder
that occurs in individuals suffering from chronic forms of liver
(hepatic) disease and acute liver failure. Sigyn Therapy is a
proprietary blood purification technology designed to deplete
pathogens, toxins and inflammatory targets from the bloodstream of
treated patients.
Hepatic Encephalopathy (HE) is induced when toxins (normally
removed by a healthy liver) accumulate in the bloodstream and then
cross through the blood brain barrier. Severe cases of HE (grade 3
and 4) can cause serious, life-threatening complications that range
from decreased consciousness to coma. 30-day mortality rates
of 38% have been reported in cirrhotic patients suffering from
grade 3 and 4 Hepatic Encephalopathy.
In the study, clinically relevant levels of bile acid, bilirubin
and ammonia were spiked into 1000ml of human blood plasma, which
was then circulated through an adult version of Sigyn Therapy at
normal treatment blood-flow rates. The study was conducted in
triplicate over four-hour time periods.
The in vitro clearance of bile acid from human blood plasma was
rapid, with an average reduction of 80.6% in one hour and 99% at
the completion of the four-hour study. Average bilirubin reduction
at one hour was 55% and 69.5% at four hours. 32% of ammonia
was eliminated from human blood plasma in one hour and an average
elimination of 37% was reported at four hours.
“We created Sigyn Therapy to overcome the limitations of
previous blood purification technologies,” stated Jim Joyce,
Chairman and CEO of Sigyn Therapeutics. “The broad-spectrum
clearance of hepatic toxins reinforces our therapeutic vision and
expands the potential use of Sigyn Therapy to include acute and
chronic liver indications.”
Beyond the accumulation of hepatic toxins in the bloodstream,
excessive inflammatory cytokine and endotoxin production contribute
to increase the permeability of the blood brain barrier in those
suffering from HE. Thus, enabling the direct interaction of
hepatic toxins with brain tissue. Among the most prominent HE
related cytokines are tumor necrosis factor-α (TNF-α), interleukin
6 (IL-6) and interleukin 1 beta (IL-1b). In previous studies,
Sigyn Therapy demonstrated the simultaneous depletion of endotoxin,
TNF-a, IL-6 and IL-1b from human blood plasma.
The resulting data from 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) prior to year-end 2021.
About Sigyn Therapeutics
Sigyn Therapeutics™ is focused on significant unmet need in
global health; the treatment of life-threatening inflammatory
conditions that are precipitated by Cytokine Storm Syndrome. The
annual market opportunity exceeds $20 billion.
Sigyn Therapy™ is a multifunctional blood purification
technology designed to mitigate the Cytokine Storm that underlies
Sepsis (the #1 cause of in-hospital deaths) and other
high-mortality inflammatory disorders commonly induced by bacterial
and viral pathogens. To overcome the limitations of previous
therapies, Sigyn Therapy addresses the source of inflammation
(viral pathogens, bacterial toxins) in concert with the
broad-spectrum depletion of inflammatory cytokines from the
bloodstream. Additionally, the device establishes a
therapeutic strategy to target CytoVesicles that transport
inflammatory cargos throughout the circulatory system.
Sigyn Therapy incorporates a formulation of adsorbent components
that optimize the broad-spectrum elimination of therapeutic targets
from the bloodstream without the risk of direct blood-cell
interactions. To support widespread implementation, Sigyn Therapy
is a single-use disposable device designed for use on the
established infrastructure of hemodialysis and continuous renal
replacement therapy (CRRT) machines already located in hospitals
and clinics worldwide. The Company has also completed studies that
reinforce the potential use of Sigyn Therapy to address acute and
chronic liver indications, with an initial focus directed toward
hepatic encephalopathy.
To learn more, visit www.SigynTherapeutics.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.
Media Contacts:
Russo Partners, LLC
David Schull
(212) 845-4271
David.Schull@russopartnersllc.com
Nic Johnson
(212) 845-4242
Nic.Johnson@russopartnersllc.com
Corporate Contact:
Jim Joyce
Chairman, CEO
619.353.0800 x301
jj@sigyntherapeutics.com
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