- 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 products
- Freeze-dried plasma product is focused on reducing battlefield morbidity and mortality, with broad additional potential clinical uses in the civilian market
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 general public."
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 distributor network.
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. PNalbone@vasc.com (763) 656-4371Source:Vascular Solutions, Inc.