Portland, OR, United States
Portland, OR, United States
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Grant
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.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 224.10K | Year: 2014

? DESCRIPTION (provided by applicant): Non-variceal upper gastrointestinal bleeding (NVUGIB) is a major cause of morbidity and mortality worldwide. Incidence of NVUGIB in the US is 53 events per 100,000 adults, with approximately 160,000 hospital admissions annually. US treatment and prevention of NVUGIB continues to be a major medical emergency, costing 550-900 million dollars every year. Failure in standard of care for NVUGIB results in mortality rates from 3-4% in the US. An improved hemostatic approach to NVUGIB will significantly reduce hemorrhage related morbidity and mortality with substantial follow-on benefits to patient comfort and reduced cost in hospital care. An ideal device would be nontoxic, provide immediate hemostasis, would not requiresignificant follow-up or removal, and allow low accuracy/acuity placement. This proposal addresses the development of such a device. To address serious NVUGIB, HemCon proposes to develop a chitosan gastrointestinal hemostatic dressing (CGHD) suitable for


Patent
HemCon Inc | Date: 2015-02-04

The present invention comprises chitosan materials and methods of using carbonic acid for aqueous solubilization of neutralized or pre-treated chitosan gels and provides, among other things, substantially acid salt free composition native final forms without requiring subsequent acid salt elution. The invention includes chitosan-based solid and semi-solid material forms, optionally reinforced with chitosan fibers, such as powders, fibers, films, matrices, sponges, implants, scaffolds, fillers, and hydrogels. Native final forms are produced from chitosan powder solubilized in an aqueous acidic solution, processed to form a high pH hydrated chitosan gel precipitate material that is then neutralized by water washing and re-solubilized substantially to chitosan solution using carbonic acid. Chitosan materials can be mixed in solution with one or more of other hydrophilic polymers to create compositional heterogeneity and pharmaceutical agents to achieve controlled release of the agent(s) from the final forms at the site of application.


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.


Patent
HemCon Inc | Date: 2011-07-04

A wound dressing device for use with a transcutaneous medical device such as a cannula or a catheter comprises a polyurethane matrix which may be covered with a film backing. Chlorhexidine di- gluconate and a polyanhydroglucuronic salt are contained in the polymer matrix. The wound dressing device prevents microbial colonization of the dressing and stops bleeding from the insertion site. The device provides combined haemostatic and antimicrobial effects at the insertion site but without adversely affecting wound healing.


The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.


The invention relates to biocompatible, bioabsorbable derivatized non-crosslinked chitosan compositions optionally crosslinked to gelatin/collagen by 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC) for biomedical use and methods of making and testing such compositions, including a modified acute systemic toxicity test. The compositions comprise derivatized chitosan reacetylated to a degree of N-deacetylation (DDA) of between about 15% and 40%. The compositions are typically bioabsorbed in about 90 days or less and can be made to bioabsorb at differing rates of speed. The compositions are initially soluble in aqueous solution below pH 6.5. The compositions have an acid content that can be adjusted between about 0% (w/w) and about 8% (w/w) to customize the composition for uses that require and/or tolerate differing levels of cytotoxicity, adhesion, composition cohesion, and cell infiltration into the composition.


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.


Patent
HemCon Inc | Date: 2012-11-30

A surgical gel system for coating and adhering to a wound area to control bleeding whilst supporting wound healing comprises polyanhydroglucuronic acid or a biocompatible salt in an amount of from 1% to 15% by weight and pectin in an amount of in an amount of from 0.1% to 9% by weight. The gel system may be used for stopping bleeding during or after sinus surgery, for stopping bleeding in ear nose and throat procedures, for stopping bleeding in gynecological procedures, or for stopping bleeding in internal organ procedures.

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