Hemostatic Agent Development Navy SBIR FY2010.1 Sol No.: Navy SBIR FY2010.1 Topic No.: N101-085 Topic Title: Hemostatic Agent Development Proposal No.: N101-085-0667 Firm: HemCon Inc 10575 SW Cascade Ave Suite 130 Portland, Oregon 97223-4363 Contact: Simon McCarthy Phone: (503) 245-0459 Web Site: www.hemcon.com Abstract: We will develop a novel hemostatic, antimicrobial, resorbable, nanofiber dressing utilizing proven hemorrhage control technology in combination with novel advanced technologies. The nanofiber dressing will be prepared using scaleable NanospiderT electrospinning technology. Nanofiber Based Dressing Constructs (NBDCs) can be prepared to have physical and chemical attributes that closely resemble natural biologic matrix forms such as the body's extracellular matrix. Because of these characteristics, NBDCs are readily conformable with complex injuries and provide for rapid delivery of hemostatic and antimicrobial functionality. We will investigate the use of a new absorbable, hemostatic, electrospinnable chitosan derivative. The chitosan derivative resorbs rapidly and meets ISO 10993 requirements for a resorbable implantable material. HemCon has performed allergenic human trials using the original base chitosan and has demonstrated absence of shrimp or other allergic responses in hypersensitive individuals. Chitosan surface area, in conjunction with shear promotes platelet activation of clotting. The very high specific surface area of chitosan in the NBDC provides significant advantages in controlling hemorrhage and addressing contamination. HemCon will partner with Haemostatix Ltd to further enhance hemostatic activity by the conjugation of a fibrinogen binding peptide (GPRP) to the NBDC. Initial studies demonstrate that peptide surface coating will control hemorrhage within one minute. Benefits: The new antimicrobial, hemostatic NBDC will provide for rapid control of hemorrhage and microbial contamination in combat or in the surgical suite. As well as being highly conformable, only fractions of a gram of the NBDC will be necessary to control hemorrhagic bleeding and address microbial contamination. The raw ingredients for this product are currently readily available and have been shown to be safe and efficacious in acute wound care applications. HemCon has built a pilot production facility for medical device manufacture of NBDC's that is capable of producing intermediate manufacturing NBDC volumes (500,000) annually. Marketing analyses have indicated an initial $3bn civilian market size for an absorbable hemostat that can control hemorrhage. The NBDC proposed here would compete with a new Johnson & Johnson fibrin biologic dressing (in final development) in efficacy but cost significantly less to produce. Also the nanofiber composition and lack of bulk or weight in the dressing would allow for substantial weight and volume saving considerations with respect to combat field use. The NBDC will have very good shelf-life properties being expected to be able to withstand a temperature range of -40�C to 50�C. Return