SAN DIEGO, CA -- August 10, 2021 -- InvestorsHub NewsWire --
Sigyn Therapeutics, Inc. (OTC
Markets: SIGY), a medical technology
company focused on the treatment of sepsis and other
life-threatening inflammatory conditions, today released the
following note authored by its Chairman and CEO, Jim Joyce.
Sigyn Therapeutics was founded on the belief that a properly
designed medical device could address sepsis and other
life-threatening inflammatory conditions that remain beyond the
reach of drug therapies.
This belief is reflected through our development of Sigyn
Therapy. Since December 2020, we reported results from a series of
studies that have demonstrated first-in-industry capabilities of
Sigyn Therapy to address pathogen sources of inflammation, deadly
toxins and relevant inflammatory mediators.
Among the therapeutic targets validated were viral pathogens
(including COVID-19), bacterial endotoxin, relevant inflammatory
cytokines (IL-6, IL-1b, TNF-a) and hepatic toxins (ammonia,
bilirubin, and bile acid). We also completed a study that
modeled our ability to capture CytoVesicles that transport
inflammatory cargos throughout the bloodstream.
Contributing to these expansive capabilities is a formulation of
adsorbent components that are incorporated within Sigyn
Therapy. Our adsorbent formulation provides more than 170,000
square meters of surface area on which to adsorb and remove
bloodstream targets. This equates to more than 40 acres of surface
adsorption area in each adult version of Sigyn Therapy.
Conversely, consider that the ~$340 million market value of our
closest public comparable is driven by an adsorption device (market
cleared to treat life-threatening inflammatory conditions outside
the U.S.) with approximately one-fourth of our surface area
capacity and based on an adsorbent bead component whose maximum
pore size to eliminate inflammatory targets is reported to be 5
nanometers. Sigyn Therapy has been demonstrated to address
inflammatory targets as well as pathogen sources of inflammation
whose molecular size can exceed 100 nanometers in
size.
Beyond our broad-spectrum capacity to remove bloodstream
targets, we disclosed on July 29th, the completion of our
first-in-mammal pilot study that demonstrated the safe
administration of Sigyn Therapy during six-hour treatment
exposures. In the coming months, we will continue to collect
animal safety data, which will be included in an Investigational
Device Exemption (IDE) that we are drafting for submission to The
United States Food and Drug Administration (FDA) to support the
initiation of human clinical studies.
Sincerely, Jim
About Sigyn Therapeutics
Sigyn Therapeutics™ is focused on a 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
Sigyn Therapeutics (QB) (USOTC:SIGY)
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