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Portland, OR, United States

Agency: Department of Defense | Branch: Navy | Program: SBIR | Phase: Phase I | Award Amount: 70.00K | Year: 2010

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 Nanospider™ 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.

Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 226.19K | Year: 2009

DESCRIPTION (provided by applicant): HemCon, Inc. PA-08-051 Chitosan Endoluminal Hemostatic Dressing Project Summary Abstract P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy Abstract The goal of this proposal is to demonstrate Phase I feasibility of a chitosan endoluminal hemostatic dressing (CEHD) that can be delivered through a Foley catheter to control and prevent urethral bleeding in a swine model. This swine model is a model of efficacy of blocking hemorrhage associated with transurethral resection of the prostate (TURP). TURP is the first line surgical treatment for benign prostate hyperplasia (BPH). TURP is performed about 100,000 times per year in the US. Post-operative hemorrhage after TURP is one of the major causes of prolonged catheterization and hospitalization, occurring in 6-10% of patients. Our device will be used to place a relatively inexpensive proprietary bandage via the catheter to prevent prolonged bleeding. This would allow for early catheter removal, improved patient comfort, accelerated recovery and significantly reduced hospital costs due to shorter hospital stays. Proprietary chitosan based dressings have been developed by HemCon and are FDA approved for controlling hemorrhage, especially on the battlefield. We have adapted the HemCon dressing as the CEHD to enable it to be used to control bleeding and facilitate surgery in the TURP procedure. Modifications to the HemCon dressing have been reduction in wall thickness (from 1.2 mm to ~200 ltm) and improvement in resistance to dissolution. In this Phase I proposal we will: i) further refine the CEHD so that it can be applied by a Foley catheter to the resected prostrate surface to stay in place for up to 72 hours to control blood flow in the presence of urine; and ii) test the efficacy of the bandage by comparing severity and duration of hematouria in the swine model of TURP. Feasibility criteria in this study will be: i) the CEHD demonstrates significantly reduced bleeding in the first 24 hours compared to current standard of practice; ii) there is no significant enhancement in injury infection or inflammation in the CEHD group compared to standard of practice; iii) the CEHD can be removed by dissolution with a low pH irrigation solution. Phase II studies will lead to an FDA submission for clinical trials. PUBLIC HEALTH RELEVANCE: HemCon Medical Technologies, Inc. PA-08-051 Chitosan Endoluminal Hemostatic Dressing Project Narrative P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy Project Narrative Bleeding from prostatic cavity is the major complication in resection of enlarged prostatic gland tissue for the treatment of benign prostatic hyperplasia (BPH). Prolonged urethral catheterization due to significant post-operative bleeding mostly causes discomfort of the patients and increases the risk of urinary infection and other chronic complications. The motivation of this project, based upon our successful prototype of chitosan hemostatic dressing, is to develop an innovative endoluminal chitosan hemostatic dressing to control and prevent the prostatic bleeding and shorten the catheterization time after prostatic surgery. Our long-term goal is to provide a safe, effective and convenient technique to treat and prevent the bleeding from prostatic surgeries.

The inventive device and methods described herein address the introduction of a safe and effective freeze-dried biological product, and particularly a plasma product, to a subject in need thereof. The present invention relates to a multifunctional, staged closure device, which also is described as a lyophilization container for plasma (LCP). The device and methods described herein address how to reproducibly achieve a low moisture and substantially oxygen-free atmosphere within a finally hermetically sealed biocompatible low aspect plastic vessel within a standard shelf-stoppering freeze dryer. The present inventive device and methods provide a freeze-dried plasma product that is fully traceable, preserves the constituent plasma activity, is readily prepared in a sterile fashion, is stable, ensures ease of storage and permits rapid reconstitution and delivery to a patient.

Improved hemostatic agents take the form of granules or particles that can be used to stanch, seal, or stabilize a site of hemorrhage, including a noncompressible hemorrhage.

Improved hemostatic agents take the form of granules or particles that can be used to stanch, seal, or stabilize a site of hemorrhage, including a noncompressible hemorrhage.

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