Pressure BioSciences
Ultra Shear Technology Nanoemulsions Platform Targets Revolution
in
Effectiveness of Therapeutics via Improved Drug Delivery and Dosing
Safety
PBI Announces Collaboration
to Improve and Optimize SinuSys Corp's Lead Sinus
Health Product Candidate for
Commencement of Phase IIb Clinical Study
South
Easton, MA -- January 20, 2021 -- InvestorsHub NewsWire
-- Pressure
BioSciences, Inc. (OTCQB:
PBIO) ("PBI" or the "Company"), a leader in the development and
sale of broadly enabling, pressure-based instruments, consumables,
and platform technology services
to
the
worldwide
biotechnology,
biotherapeutics, and other
industries, today announced a collaboration
with SinuSys Corporation. The primary goal
of the collaboration is to evaluate the feasibility of PBI's
innovative Ultra Shear Technology™ ("UST™") platform to
improve the effectiveness
of
SinuSys Corp's lead product candidate Restora.
If successful,
SinuSys intends to license PBI's UST
platform for use in Restora on
its
continued
path
to FDA approval in
a
Phase IIb clinical
study
later in 2021.
SinuSys reports that chronic
sinusitis affects more than 31 million people in the United
States
and
that it
is more prevalent than heart disease
or
asthma and has a greater impact on patients' quality of life than
chronic back pain or congestive heart failure.
The majority of
patients with chronic sinusitis are treated with oral antibiotics
and/or nasal steroids, which can increase the risk of antibiotic
resistance and cause unwanted side effects such as nose bleeds,
nasal ulcers, and nasal and oral infections. The most
effective
sinusitis
treatment
is
Functional Endoscopic Sinus Surgery (FESS)
with rapid
balloon dilation at high pressures, which
is
known to cause significant patient discomfort and
is
conducted in a surgical suite under general anesthesia or IV
sedation.
Annually,
it is estimated that
$11 billion
is spent in the U.S. alone
on improving the health of patients with sinus
conditions.
SinuSys
Corporation,
a
medical device company focused on developing new therapies to
improve the sinus health of patients, is led by
co-founder and CEO Thomas A.
Schreck. Prior to
SinuSys, Mr. Schreck was
the founding Chairman and CEO of AcelRx, as well
as the founding CEO
and President, CFO, and Director of DURECT Corporation. He
has also held various investment banking positions in the San
Francisco Bay area and London and
has
raised over $300 million for medical device and biotechnology
companies throughout
his
career.
Mr.
Schreck explained:
"In
the post-FESS patient population, drug-eluting spacers or stents
are typically inserted into the surgically revised
sinus opening to deliver
steroids locally for reduction of inflammation, scarring and
adhesions. Traditional
spacers or stents
are designed to slowly degrade and be bio-absorbed in place, but
their polymer
scaffolds can degrade unevenly, causing
inflammation and
requiring
surgical removal
of remnants and damaged tissue. Our lead
product candidate
Restora infuses the desired steroid via a bio-inert and
non-inflammatory matrix material that is long-proven with exemplary
safety profiles in humans,
and that
is
simply
and painlessly inserted
and then
fully
removed by the physician after treatment."
Mr.
Schreck continued: "We believe that
PBI's patented
UST
platform
for
the preparation of nanoemulsions is a compelling
transformational technology
for
therapeutics.
Its
use is expected
to require loading
less of the
active
steroid into the Restora device, while optimizing controlled
dosing
delivery with minimized risk of overdose exposure
to
the
patient. We
are excited to work with PBI's outstanding team of scientists and
innovators on this opportunity to improve and
optimize our lead compound with their
next-generation, UST-based
nanoemulsion
technology, which we believe will
enhance the
probability for a
successful Restora
Phase
IIb trial later this
year."
Dr.
Alexander V. Lazarev, PBI's Chief Science Officer,
commented:
"Our patented UST
platform is
a unique breakthrough
for
nanoemulsification
processing
designed to
resolve multiple
substantive
problems
facing manufacturers
of therapeutic
drugs,
nutraceuticals,
and
other products
containing
hydrophobic
(water
repelling) active
ingredients that
are at best poorly
soluble in
water. Poor water
solubility results in
lower
absorption
rates
and
requires much higher loading of the
active
compounds
into products to achieve targeted dosing and
bioavailability of active ingredients
for
the patient.
Unfortunately, poor water
solubility also carries
overdosing risks in conventional
emulsions due to
oil
and water phases further separating and leading to
non-uniform drug distribution.
Scientific
publications have demonstrated that hydrophobic active ingredients
manufactured into high quality nanoemulsions with
droplet sizes of
less than 100 nanometers can facilitate increased
absorption and bioavailability while lowering
doses and improving controlled release.
This should
result
in
better
quality
products and treatment
experiences for the
patient,
with overall reduction in product costs."
In the
post-surgical nasal drug delivery markets, two companies that stand
out at present are
Intersect ENT and
Lyra Therapeutics.
Intersect is a
medical technology company with existing
products on the
market, including mini
drug-releasing
implants for patients
undergoing sinus surgery to treat chronic
sinusitis. Lyra is a
clinical-stage company developing drugs and new treatment options
targeting ears, nose, and
throat ("ENT")
conditions.
Mr.
Richard
T. Schumacher, President
& CEO of PBI,
provided context on these opportunities: "We
believe the therapeutics applications for our uniquely
enabling
UST nanoemulsions
technology
platform
will
be transformational across a wide swath of pharmaceutical,
biopharmaceutical, nutraceutical, cosmeceutical, dermatological,
medical device,
and
many other applications and markets. We are at
an
exciting
moment in PBI's
development when our
new,
proprietary UST
technology
platform
is
soon
to be commercially released (mid to late
2021)
and
initial collaborations are being both
announced
and
commenced.
We
have recently
been
approached
by several
other
companies
with
therapeutics applications.
We
anticipate
multiple additional collaboration and licensing
announcements soon,
all of which we believe could add significantly to
our
revenue in
2021,
and
beyond."
About
Pressure
BioSciences,
Inc.
Pressure
BioSciences,
Inc.
(OTCQB:
PBIO)
is
a
leader
in
the
development
and
sale
of
innovative,
broadly
enabling,
pressure-based
solutions
for
the
worldwide
life
sciences
and
other
industries.
Our
products
are
based
on
the
unique
properties
of
both
constant
(i.e.,
static)
and
alternating
(i.e.,
pressure
cycling
technology,
or
PCT)
hydrostatic
pressure.
PCT
is a
patented
enabling
technology
platform
that
uses
alternating
cycles
of hydrostatic
pressure
between
ambient
and
ultra-high
levels
to
control
bio-molecular
interactions
safely
and
reproducibly
(e.g.,
cell
lysis,
biomolecule
extraction).
Our
primary
focus
is
the
development
of
PCT-based
products
for
biomarker
and
target
discovery,
drug
design
and
development,
biotherapeutics
characterization
and
quality
control,
soil
&
plant
biology,
forensics,
and
counter-bioterror
applications.
Additionally,
major
new
market
opportunities
have
emerged
in
the
use
of
our
pressure-based
technologies
in
the
following
areas:
(1)
the
use
of
our
recently
acquired,
patented
technology
from
BaroFold,
Inc.
(the
"BaroFold"
technology)
to
allow
entry
into
the
bio-pharma
contract
services
sector,
and
(2)
the
use
of
our
recently-patented,
scalable,
high-efficiency,
pressure-based
Ultra
Shear
Technology
("UST")
platform
to
(i)
create
stable
nanoemulsions
of
otherwise
immiscible
fluids
(e.g.,
oils
and
water)
and
to
(ii)
prepare
higher
quality,
homogenized,
extended
shelf-life
or
room
temperature
stable
low-acid
liquid
foods
that
cannot
be
effectively
preserved
using
existing
non-thermal
technologies.
Forward
Looking
Statements
This
press
release
contains
forward-looking
statements.
These
statements
relate
to
future
events
or
our
future
financial
performance
and
involve
known
and
unknown
risks,
uncertainties
and
other
factors
that
may
cause
our
or
our
industry's
actual
results,
levels
of
activity,
performance,
or
achievements
to
be
materially
different
from
any
future
results,
levels
of activity,
performance
or
achievements
expressed,
implied,
or
inferred
by
these
forward-looking
statements.
In
some
cases,
you can
identify
forward-looking
statements
by
terminology
such
as
"may,"
"will,"
"should,"
"could,"
"would,"
"expects,"
"plans,"
"intends,"
"anticipates,"
"believes,"
estimates,"
"predicts,"
"projects,"
"potential"
or
"continue"
or
the
negative
of
such
terms
and
other
comparable
terminology.
These
statements
are
only
predictions
based
on
our
current
expectations
and projections
about
future
events.
You
should
not
place
undue
reliance
on
these
statements.
In
evaluating
these
statements,
you
should
specifically
consider
various
factors.
Actual
events
or
results
may
differ
materially.
These
and
other
factors
may cause
our actual
results
to
differ
materially
from
any
forward-looking
statement.
These
risks,
uncertainties,
and
other
factors
include,
but
are
not
limited
to,
the
risks
and
uncertainties
discussed
under
the
heading
"Risk
Factors"
in
the
Company's
Annual
Report
on
Form
10-K
for
the
year
ended
December
31,
2019,
and
other
reports
filed
by
the
Company
from
time
to
time
with
the
SEC.
The
Company
undertakes
no
obligation
to
update
any
of
the
information
included
in this
release,
except
as
otherwise
required
by law.
Contacts:
Richard
T. Schumacher, President & CEO,
PBI
(508) 230-1828 (T)
Jeffrey N. Peterson, Chairman,
PBI
(650) 812-8121 (T)
Thomas A. Schreck,
CEO, SinuSys Corp.
(650) 714-0445 (T)
For
more
information
about
PBI
and
this
press
release,
please
click
on the
following
website
link:
http://www.pressurebiosciences.com
Please
visit
us
on
Facebook,
LinkedIn,
and
Twitter.
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