Lexington,
MA,
October
14,
2025
–(PR.com)– Hemanext
Inc.,
a
leading
innovator
in
blood
processing,
storage,
and
transfusion
technology,
has
been
awarded
a
three-year
Small
Business
Innovation
Research
Grant
(SBIR)
Phase
II
for
a
project
titled,
“Efficacy
of
Hypoxic
Red
Blood
Cells
Processed
with
the
Hemanext
ONE®
System
in
Patients
with
Sickle
Cell
Anemia,”
to
support
and
strengthen
the
clinical
efforts
of
hypoxically
stored
red
blood
cells
(HRBC)
in
the
United
States
(NIH
RePORTER
link).
The
NIH
SBIR
program
provides
competitive
funding
to
small
businesses
with
high-impact
ideas
that
have
a
strong
potential
for
public
health
benefit.
Despite
several
new
therapies
that
have
been
developed
over
the
past
few
years,
including
pharmacologic
and
gene
therapy,
they
are
not
available
or
tolerable
to
all
sickle
cell
disease
(SCD)
patients.
These
anemic
patients
continue
to
require
RBC
transfusions.
Chronically
transfused
sickle
cell
anemia
(SCA)
patients
are
a
highly
vulnerable
population
because
they
are
entirely
dependent
upon
frequent
transfusions
of
conventional
RBCs
to
remain
healthy.
For
these
patients,
blood
transfusion
therapy
is
the
only
viable
option
for
survival.
HRBC
transfusions
have
emerged
as
a
promising
approach
to
provide
a
high-quality
blood
product
to
potentially
improve
treatment
outcomes
in
SCA
patients.
The
awarded
clinical
trial
will
be
a
multi-center,
randomized,
controlled
study
with
a
cross-over
design
and
will
include
patients
seven
years
old
and
older.
The
primary
objective
will
evaluate
the
efficacy
of
HRBC
by
measuring
the
rate
of
decline
in
%Hemoglobin
A
and
assessing
HRBC’s
impact
on
reducing
the
patients’
transfusion
burden.
Furthermore,
the
study
will
evaluate
transfusion-related
outcomes,
including
a
comprehensive
array
of
clinical
and
laboratory
parameters
and
quality
of
life
assessments.
Dr.
Laurel
Omert
will
be
the
contact
Principal
Investigator
(PI)
with
Dr.
Biree
Andemariam
and
Dr.
Enrico
Novelli
as
co-PIs.
“I
am
delighted
to
be
able
to
work
with
a
group
of
such
distinguished
investigators
in
the
field
of
sickle
cell
anemia
to
study
the
effect
of
large
volume
red
blood
cell
exchange
transfusions
of
HRBC
in
this
underserved
population,”
said
Laurel
Omert,
MD,
Chief
Medical
Officer
of
Hemanext.
Andrew
Dunham,
CEO
of
Hemanext
stated,
“This
award
marks
a
significant
milestone
for
our
team
and
validates
the
promise
of
our
approach
to
transform
transfusion
medicine.
We
are
honored
and
excited
to
receive
this
NIH
SBIR
grant,
which
underscores
the
significance
of
our
work
and
its
potential
to
address
unmet
clinical
needs.”
HEMANEXT
ONE®
received
marketing
authorization
for
commercial
distribution
via
the
De
Novo
process
by
the
U.S.
Food
&
Drug
Administration
in
2023
and
has
been
CE
marked
since
2021.
Funding
Acknowledgment
This
project
is
supported
by
the
National
Heart,
Lung,
And
Blood
Institute
of
the
National
Institutes
of
Health
under
Award
Number
R44HL178006.
The
content
of
this
announcement
is
solely
the
responsibility
of
the
authors
and
does
not
necessarily
represent
the
official
views
of
the
National
Institutes
of
Health.
About
Hemanext
Hemanext
is
a
privately
held
medical
technology
company
based
in
Lexington,
MA
that
is
dedicated
to
improving
the
quality,
safety,
efficacy,
and
cost
of
transfusion
therapy.
The
company’s
research
and
development
efforts
focus
on
the
study
of
hypoxically
stored
red
blood
cells.
The
company’s
aim
is
to
significantly
improve
the
quality
of
stored
RBCs
worldwide.
About
Hemanext
ONE
HEMANEXT
ONE
is
a
first
in
class
device
to
improve
the
quality
of
RBCs
for
transfusion
dependent
patients.
HEMANEXT
ONE
has
been
granted
marketing
authorization
for
commercial
distribution
via
the
De
Novo
process
by
the
U.S.
Food
&
Drug
Administration
further
exhibiting
the
product’s
innovation
and
commercial
impact.
In
Europe,
HEMANEXT
ONE
is
CE
marked,
allowing
commercial
distribution
within
the
market
of
the
European
Economic
Area.
Visit
Hemanext.com
to
learn
more
about
the
Company
and
its
flagship
product
HEMANEXT
ONE.