Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare
company and leading manufacturer of plasma-derived medicines, today
announced that its plasma-protein based fibrin sealant (FS) for
controlling surgical bleeding has received approval from the United
States Food and Drug Administration (FDA) for pediatric patients.
The U.S. indication for children and adolescents extends the
availability of FS, which is already approved for this patient
segment in Europe, in addition to adults. During surgery Grifols FS
promotes hemostasis and tissue sealing, resulting in reduced blood
loss and potentially fewer complications.
Grifols FS biosurgery treatment is commercialized as VISTASEAL™
in the U.S. and Canada, and VERASEAL™ in Europe and elsewhere. Both
brands are marketed and distributed by Johnson & Johnson
MedTech, as part of a strategic collaboration between the two
companies announced in 2019.
Grifols FS combines two plasma proteins, fibrinogen and
thrombin, and is applied with Johnson & Johnson MedTech’s
airless spray technology to rapidly form clots. The FS solution is
now available in 18 countries.
In early 2023, Grifols announced that it had met all primary and
secondary endpoints of its phase 3b study evaluating the
administration of Grifols FS to pediatric patients, defined as
those not having reached 18 years of age. Researchers conducted a
global prospective, randomized, active-controlled, single-blind,
parallel group clinical trial designed to evaluate the safety and
efficacy of the FS as an adjunct to hemostasis during surgery in
pediatric patients (compared with an active control). The study
included a total of 178 patients enrolled and treated across 18
recruitment centers.
A greater than 95% efficacy rate was achieved in both treatment
arms, with hemostasis within four minutes of application. In
addition, Grifols FS demonstrated a good safety and tolerability
profile, as the distribution of adverse events was comparable
between arms.
“Developing innovative biosurgery solutions reflects Grifols’
ability to provide patients with more medicines across many
therapeutic areas to enhance their well-being,” said Joerg
Schuettrumpf, Grifols Chief Scientific Innovation Officer.
It’s estimated that between roughly one-third and two-thirds of
open surgeries experience disruptive bleeding,1 while challenging
and uncontrollable bleeding during surgery is associated with high
mortality rates.1,2
About VISTASEAL VISTASEAL is a
single-use product that uses a combination of human fibrinogen and
human thrombin to assist with mild to moderate bleeding control
when standard surgical techniques such as suture or cautery are
ineffective. The sealant is applied in a thin layer over the
bleeding tissue in order to generate a cross-linked fibrin clot to
achieve hemostasis. VISTASEAL can be utilized in high-risk patients
when there are concerns regarding coagulopathy, antiplatelets,
anticoagulants, and friable tissue.
VISTASEAL™ Fibrin Sealant (Human)
IMPORTANT SAFETY INFORMATION
INDICATIONVISTASEAL™, a fibrin sealant, is
indicated as an adjunct to hemostasis for mild to moderate bleeding
in patients undergoing surgery when control of bleeding by standard
surgical techniques (such as suture, ligature, and cautery) is
ineffective or impractical. VISTASEAL™ is effective in heparinized
patients.
CONTRAINDICATIONSDo not inject directly into
the circulatory system. Do not use for the treatment of severe or
brisk arterial bleeding.Do not use in patients with history of
anaphylaxis or severe systemic reactions to human blood products.Do
not use VISTASEAL™ for spraying unless the minimum recommended
distance from the applicator tip to the bleeding site can be
achieved.
WARNINGS AND PRECAUTIONS Thromboembolic events
may occur if VISTASEAL™ is administered intravascularly.
Hypersensitivity reactions can occur. May carry a risk of
transmitting infectious agents, e.g., viruses, the variant
Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent.
ADVERSE REACTIONSThe most common adverse
reactions (reported in >1% of patients) were procedural pain,
and nausea.
For complete indications, contraindications, warnings,
precautions, and adverse reactions, please reference
full package insert.MEDIA
CONTACTS:
Grifols Press Office
media@grifols.comTel. +34 93 571 00 02
SpainDuomo ComunicaciónTel.: +34 91 311 92 89 – +34 91 311 92
90Raquel Lumbreras (Tel. +34 659 572
185)Raquel_lumbreras@duomocomunicacion.comBorja Gómez (Tel. + 34
659 572 185)Borja_gomez@duomocomunicacion.com
InvestorsInvestors Relations &
Sustainabilityinversores@grifols.com - investors@grifols.comTel.
+34 93 571 02 21 About Grifols
Grifols is a global healthcare company founded
in Barcelona in 1909 committed to improving the health and
well-being of people around the world. A leader in essential
plasma-derived medicines and transfusion medicine, the company
develops, produces, and provides innovative healthcare services and
solutions in more than 110 countries.
Patient needs and Grifols’ ever-growing
knowledge of many chronic, rare and prevalent conditions, at times
life-threatening, drive the company’s innovation in both plasma and
other biopharmaceuticals. Grifols is focused on treating conditions
across a broad range of therapeutic areas: immunology, hepatology
and intensive care, pulmonology, hematology, neurology, and
infectious diseases.
A pioneer in the plasma industry, Grifols
continues to grow its network of donation centers, the world’s
largest with over 390 across North America, Europe, Africa and the
Middle East, and China.
As a recognized leader in transfusion medicine,
Grifols offers a comprehensive portfolio of solutions designed to
enhance safety from donation to transfusion, in addition to
clinical diagnostic technologies. It provides high-quality
biological supplies for life-science research, clinical trials, and
for manufacturing pharmaceutical and diagnostic products. The
company also supplies tools, information and services that enable
hospitals, pharmacies and healthcare professionals to efficiently
deliver expert medical care.
Grifols, with more than 23,000 employees in more
than 30 countries and regions, is committed to a sustainable
business model that sets the standard for continuous innovation,
quality, safety, and ethical leadership.
The company’s class A shares are listed on the
Spanish Stock Exchange, where they are part of the Ibex-35
(MCE:GRF). Grifols non-voting class B shares are listed on the
Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs
(NASDAQ:GRFS).
For more information about Grifols, please visit
grifols.com
LEGAL DISCLAIMERThe facts and
figures contained in this report that do not refer to historical
data are “future projections and assumptions.” Words and
expressions such as “believe,” “hope,” “anticipate,” “predict,”
“expect,” “intend,” “should,” “will seek to achieve,” “it is
estimated,” “future” and similar expressions, in so far as they
relate to the Grifols group, are used to identify future
projections and assumptions. These expressions reflect the
assumptions, hypotheses, expectations and predictions of the
management team at the time of writing this report, and these are
subject to a number of factors that mean that the actual results
may be materially different. The future results of the Grifols
group could be affected by events relating to its own activities,
such as a shortage of supplies of raw materials for the manufacture
of its products, the appearance of competitor products on the
market, or changes to the regulatory framework of the markets in
which it operates, among others. At the date of compiling this
report, the Grifols group has adopted the necessary measures to
mitigate the potential impact of these events. Grifols, S.A. does
not accept any obligation to publicly report, revise or update
future projections or assumptions to adapt them to events or
circumstances subsequent to the date of writing this report, except
where expressly required by the applicable legislation. This
document does not constitute an offer or invitation to buy or
subscribe shares in accordance with the provisions of the following
Spanish legislation: Royal Legislative Decree 4/2015, of 23
October, approving recast text of Securities Market Law; Royal
Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4
November, and any regulations developing this legislation. In
addition, this document does not constitute an offer of purchase,
sale or exchange, or a request for an offer of purchase, sale or
exchange of securities, or a request for any vote or approval in
any other jurisdiction. The information included in this document
has not been verified nor reviewed by the external auditors of the
Grifols group.
1 Corral M, Ferko N, Hollmann S, Broder MS, Chang E. Health and
economic outcomes associated with uncontrolled surgical bleeding: a
retrospective analysis of the Premier Perspectives
Database. Clinicoecon Outcomes Res. 2015;7:409-421.
doi:10.2147/CEOR.S863692 Marietta M, Facchini L, Pedrazzi P, Busani
S, Torelli G. Pathophysiology of bleeding in
surgery. Transplant Proc. 2006;38(3):812-814.
doi:10.1016/j.transproceed.2006.01.047
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