San Diego, California - 
(NewMediaWire) - July 13, 2021 - 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 an invitro blood
purification study that validated the ability of Sigyn Therapy™ to eliminate
bloodstream toxins 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 a broad-spectrum of
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.
The goal of the hepatic toxin
study was to collect supporting data that would expand the potential use of
Sigyn Therapy to include chronic liver disease and acute liver failure
indications, including HE.
In previously conducted
studies, Sigyn Therapy was reported to deplete circulating pathogens,
toxins and inflammatory cytokines that play a prominent role in acute
life-threatening inflammatory conditions that underlie a $20 billion annual
market opportunity.
In the hepatic toxin study,
clinically relevant levels of ammonia, bilirubin and bile acids were
spiked into 1000ml of human blood plasma and then circulated at through an
adult version of Sigyn Therapy at normal treatment blood-flow
rates. The study was conducted in triplicate over four-hour time
periods.
In this disclosure, the Company
is reporting on the in vitro removal
of bilirubin by Sigyn Therapy. The depletion of bilirubin
from human blood plasma was rapid, with an average reduction of 55% in one hour
and 69.5% in four hours of treatment, with high levels of consistency among the
triplicate studies. Data related to Ammonia and bile acid removal
will be reported in a forthcoming disclosure.
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 data resulting 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) 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 is
also conducting studies to evaluate the potential use of Sigyn Therapy to treat
acute forms of liver failure, including 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
