BOSTON, April 29, 2021 /PRNewswire/ -- Haemonetics
Corporation (NYSE: HAE), a global medical technology company
focused on delivering innovative medical solutions to drive better
patient outcomes, announced that the full peer-reviewed results of
the IMproving PlasmA CollecTion (IMPACT) trial have been published
in TRANSFUSION, the prime journal for transfusion medicine related
research. The publication expands upon the IMPACT trial data
presented in October 2020 in a
plenary session at the AABB conference. IMPACT, a multicenter,
prospective and double-blinded study, is one of the largest
randomized controlled trials of plasmapheresis. The trial involved
3,443 donors who underwent 23,137 plasma donations.
IMPACT compared plasma collection using NexSys
PCS® with YES® Technology, which
collects plasma based on a donor's weight per the current industry
standard nomogram, to collection with NexSys
PCS® with Persona® Technology which uses
a novel, personalized Percent Plasma Nomogram (PPN) based on body
mass index (BMI) and hematocrit, to enable a more tailored
collection target. The trial found that the personalized donation
method has a non-inferior safety profile, and demonstrated a yield
increase of +8.2% more plasma per collection on average as compared
to the control, based on the donor population in the trial. Based
on the results of the IMPACT trial, Haemonetics' NexSys
PCS® system with
Persona® Technology received U.S. Food and Drug
Administration (FDA) 510(k) clearance in 2020.
"Plasma is a critical ingredient for important medicines that
can have a life-changing impact on
patients suffering from hundreds of conditions including primary immunodeficiency, hemophilia,
trauma and more," said Jan Hartmann,
Haemonetics' Vice President, Medical Affairs, Clinical Development
and Medical Safety. "We are committed to innovation and using the
best available science to change the paradigm for plasma collection
with our proprietary technology." 1,2
According to the Plasma Protein Therapeutics Association (PPTA),
approximately 750,000 people across Europe and North
America rely on plasma for life-saving therapies3
and it can take hundreds of plasma donations to treat a single
patient4.
The full publication, "Personalized collection of plasma from
healthy donors: A randomized controlled trial of a novel
technology-enabled nomogram," can be accessed in the TRANSFUSION
Journal here.
About NexSys PCS® with
Persona® Technology
The NexSys PCS® plasma collection system with
Persona® Technology is intended for use as an
automated cell separator system and blood component collector in
conjunction with single-use sterile disposable sets, with or
without saline compensation. Products that can be collected using
the NexSys PCS® system include source plasma and
plasma for transfusion. The Persona® Technology
builds on NexSys PCS® with
YES® Technology, which received FDA 510(k)
clearance in 2018 and has been used to perform millions of
collections to date and has been in extensive clinical use ever
since. The NexSys PCS® system with
Persona® Technology includes disposables and the
ability to integrate with NexLynk DMS® donor
management system. Visit www.nexsyspcs.com to learn
more.
About Haemonetics
Haemonetics (NYSE: HAE) is
a global healthcare company dedicated to providing a suite of
innovative medical products and solutions for customers, to help
them improve patient care and reduce the cost of healthcare. Our
technology addresses important medical markets: blood and plasma
component collection, the surgical suite and hospital transfusion
services. To learn more about Haemonetics,
visit www.haemonetics.com.
Cautionary Statement Regarding Forward-Looking
Information
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements. Forward-looking statements in this
press release may include, without limitation, statements regarding
plans and objectives of management for the operation of
Haemonetics, including statements regarding potential benefits
associated with the NexSys PCS® system with
Persona® Technology, and Haemonetics' plans or
objectives related to the development and commercialization of this
product. Such forward-looking statements are not meant to predict
or guarantee actual results, performance, events or circumstances
and may not be realized because they are based upon Haemonetics'
current projections, plans, objectives, beliefs, expectations,
estimates and assumptions and are subject to a number of risks and
uncertainties and other influences.
Actual results and the timing of certain events and
circumstances may differ materially from those described by the
forward-looking statements as a result of these risks and
uncertainties. Factors that may influence or contribute to the
inaccuracy of the forward-looking statements or cause actual
results to differ materially from expected or desired results may
include, without limitation, product quality; market acceptance;
the effect of economic and political conditions; the impact of the
COVID-19 pandemic, including the scope and duration of the
pandemic, government actions and restrictive measures implemented
in response; the impact of competitive products and pricing; blood
product reimbursement policies and practices; and the effect of
industry consolidation as seen in the plasma market. These and
other factors are identified and described in more detail in the
Company's periodic reports and other filings with the U.S.
Securities and Exchange Commission. The Company does not undertake
to update these forward-looking statements.
1
https://www.donatingplasma.org/plasma-protein-therapies/who-needs-plasma-therapies
2
https://www.jwatch.org/na50592/2019/12/30/prehospital-plasma-saves-lives-trauma-patients-with-longer
3 https://primaryimmune.org/specific-pi-diagnoses
4
https://www.donatingplasma.org/plasma-protein-therapies/who-needs-plasma-therapies
Investor
Contact:
|
Media
Contact:
|
Olga Guyette,
Director-Investor
Relations
|
Carla Burigatto, Vice
President-Communications
|
(781)
356-9763
|
(781)
348-7263
|
olga.guyette@haemonetics.com
|
carla.burigatto@haemonetics.com
|
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SOURCE Haemonetics Corporation