Vascular Solutions Enters Into Agreement With U.S. Army to Develop
Freeze-Dried Plasma Product
- U.S. Army will sponsor, conduct and fund all Food and Drug Administration
(FDA) required pre-clinical and clinical studies of the freeze-dried plasma
product developed by Vascular Solutions
- Vascular Solutions has completed prototype development and early bench
testing of the product, leveraging its expertise in lyophilization of biologic
- Freeze-dried plasma product is focused on reducing battlefield morbidity and
mortality, with broad additional potential clinical uses in the civilian
MINNEAPOLIS, April 22, 2014 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc.
(Nasdaq:VASC) today announced that it has entered into a cooperative research
& development agreement with the U.S. Army Medical Materiel Development
Activity (USAMMDA) to develop a freeze-dried plasma product for use in
battlefield treatment of severe hemorrhage.
The early administration of plasma has an important role in reducing
battlefield mortality rates, and therefore the USAMMDA has prioritized the
development of a freeze-dried plasma product. Currently, the only plasma
available in the United States is in the form of fresh frozen plasma (FFP),
which must be stored frozen until use and then requires a lengthy thawing
process.Due to the difficulty of using FFP in remote locations such as
military hospitals and battlefield situations, the USAMMDA has requested the
development of a stable, durably-packaged, freeze-dried plasma product that
can be easily stored, transported and used in remote locations.
Under the terms of the agreement, the USAMMDA has selected Vascular Solutions
as its development partner for the commercialization of a freeze-dried plasma
product.Vascular Solutions will be responsible for completing development of
the product and establishing manufacturing operations, including chemistry,
manufacturing, and controls (CMC) information to support the Investigational
New Drug (IND) application to the FDA. The Army will be responsible to
sponsor, manage and fund all pre-clinical and clinical studies required by the
FDA for regulatory approval, as well as to sponsor and fund a post-approval
clinical study to broaden the approved indication if required by the FDA.
Following regulatory approval, Vascular Solutions will be responsible for all
post-licensure production, regulatory and commercial marketing and
distribution of the freeze-dried plasma product, and the United States Army
will purchase quantities of the freeze-dried plasma product from Vascular
Solutions for military use. Vascular Solutions also will be entitled to market
the product to other government agencies and for civilian use, subject to
regulatory authorization.In the United States, more than four million units
of FFP are administered annually, and the growth in consumption is
accelerating in response to recent transfusion studies that demonstrated
significant decreases in mortality with a higher concentration of plasma.
"We believe that a freeze-dried plasma product will offer important benefits
for both the U.S. military and the general public," commented Howard Root,
Chief Executive Officer of Vascular Solutions. "Freeze-dried plasma will have
wide applicability in emergency situations where plasma is not currently
available or when time constraints limit the use of fresh frozen plasma.In
addition to the military and other government agencies, freeze-dried plasma
would be a natural option for rural treatment facilities and private
first-responder organizations with advanced life support capabilities."
For more than a decade, Vascular Solutions has developed extensive expertise
in the lyophilization of biologic products, which has led to the
commercialization of several successful and market-leading products, including
the D-Stat® Dry topical hemostat. During the development of the lyophilized
plasma product, Vascular Solutions has invented a process and materials for
freeze-drying and packaging human plasma for use in field settings. Vascular
Solutions has filed a U.S. patent application related to its system and method
that protects the human plasma from contamination through the steps of
filling, freeze-drying, packaging, storing, and delivery.
"Vascular Solutions is honored to have been selected through a competitive
evaluation process to work with the USAMMDA on this important initiative,"
added Mr. Root. "The lyophilization of biologic materials is one of our core
technical competencies, as we have demonstrated with multiple successful
commercial endeavors in this field. Our biologics development team has already
developed the methods for lyophilization and packaging of human plasma, and we
believe that we have the technical expertise necessary for a successful
collaboration with the USAMMDA, as well as to serve unmet needs for the
Vascular Solutions expects its freeze-dried plasma product to be regulated by
the FDA as a blood product and to require a Biologics License Application
(BLA). Vascular Solutions is currently targeting submission of the BLA in
2018-2019, following completion of the required clinical studies. Vascular
Solutions expects the BLA to target an indication of managing preoperative or
bleeding patients who require replacement of multiple plasma coagulation
factors (e.g., due to liver disease) or rapid reversal of the effect of
warfarin therapy. The company also plans to seek, as part of a Phase IV
development commitment sponsored and funded by USAMMDA, an indication for
patients with massive transfusion who have clinically significant coagulation
deficiencies. The company does not expect the development costs associated
with this program to have a material impact on its financial performance
during the development period.
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses
on developing unique clinical solutions for coronary and peripheral vascular
procedures. The company's product line consists of more than 80 products in
three categories: catheter products, hemostat products and vein
products.Vascular Solutions delivers its products to interventional
cardiologists, interventional radiologists, electrophysiologists, and vein
specialists through its direct U.S. sales force and international independent
The information in this press release contains forward-looking statements that
involve risks and uncertainties. Our actual results could differ materially
from those anticipated in these forward-looking statements. Important factors
that may cause such differences include those discussed in our Annual Report
on Form 10-K for the year ended December 31, 2013 and other recent filings
with the Securities and Exchange Commission. The risks and uncertainties
include, without limitation, risks associated with the need for adoption of
our new products, lack of sustained profitability, exposure to intellectual
property claims, significant variability in quarterly results, exposure to
possible product liability claims, the development of new products by others,
doing business in international markets, the availability of third party
reimbursement, and actions by the FDA.
For further information, connect to www.vasc.com.
CONTACT: Phil Nalbone, VP-Corp. Dev.
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