SBIR-STTR Award

In this Fast Track SBIR application, NanoVasc (Alameda, CA) plans to use its proprietary and innovative electrospinning process (initially developed at U.C. Berkeley in Dr. Song Li's Lab) to develop small diameter vascular grafts (called NanoGrafts) for the treatment of Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). NanoVasc's innovation is the development of a small diameter vascular graft (3-5mm internal diameter) using a biomimetic scaffold that is both biodegradable and bioactive. This research shows great promise for the field of vascular bypass surgeries, as the structure and morphology of electrospun, nanofibrous scaffolds can be manipulated to resemble that of natural extracellular matrix (ECM), therefore creating a more "familiar" environment for the cells to migrate into. The company has preliminary evidence showing the performance and remodeling of a 1mm internal diameter, nanofibrous vascular grafts in vivo with very encouraging results. This project will focus on developing small diameter grafts, evaluating their physico-chemical properties, biological and hemo-compatibility and platelet/thrombus interactions in vitro, and then evaluating their biocompatibility and in vivo dynamics, compatibility/patency and safety in a sheep model. In Phase I, polymer selection, surface modification, and mechanical integrity will be investigated. The candidates that pass the given criteria will then be tested for thrombogenicity, biological and hemo-compatibility using an in vitro blood recirculation loop. Phase II will focus on the in vivo patency in a sheep bilateral common carotid artery model for 28 and 140 days. Controls will include commercially available, 4mm ePTFE vascular grafts.

Public Health Relevance:
The quality of life for millions of Americans is impacted severely from the suffering associated with atherosclerotic vessel disease, especially the elderly. Research and development of a vascular conduit like the NanoVasc graft will play a key role in not only improving the quality of these patients' lives by providing better treatment options/modalities but also reduce the economic impact on the society as a whole and patients in particular. A vascular prosthesis that far exceeds the results of today's treatment options will positively affect the United States' health care system.

Public Health Relevance Statement:
Project Narrative. The quality of life for millions of Americans is impacted severely from the suffering associated with atherosclerotic vessel disease, especially the elderly. Research and development of a vascular conduit like the NanoVasc graft will play a key role in not only improving the quality of these patients' lives by providing better treatment options/modalities but also reduce the economic impact on the society as a whole and patients in particular. A vascular prosthesis that far exceeds the results of today's treatment options will positively affect the United States' health care system.

NIH Spending Category:
Aging; Assistive Technology; Atherosclerosis; Bioengineering; Biotechnology; Cardiovascular; Hematology; Nanotechnology; Rehabilitation

Project Terms:
Acute; Adhesions; Affect; Aged 65 and Over; American; Amines; Animals; Assay; Bilateral; Binding; Binding (Molecular Function); Bioassay; Biocompatible; Biodegradation; Biologic Assays; Biological; Biological Assay; Biomimetics; Bizzozero's corpuscle/cell; Blood; Blood Platelets; Blood Vessel Prosthesis; Blood Vessels; Body Weight decreased; Bypass; Caliber; Carotid Arteries; Cell-Extracellular Matrix; Cell/Tissue, Immunohistochemistry; Cells; Certification; Characteristics; Chemicals; Chromogenic Substrates; Chronic; Clinical; Clinical Trials, Phase I; Common carotid artery; Coronary Arteriosclerosis; Coronary Artery Disease; Coronary Artery Disorder; Coronary Atherosclerosis; Deetjeen's body; Deposit; Deposition; Development; Development and Research; Diameter; Dimensions; Disease; Disorder; ECM; Early-Stage Clinical Trials; Elderly; Elderly, over 65; Electromagnetic, Laser; Electrons; Embolism; Embolus; Ensure; Environment; Esthetics; Ethylene Oxide; Evaluation; Exhibits; Extracellular Matrix; Fiber; Generations; Glycolates; Goals; Government; Guidelines; H2O2; Hayem's elementary corpuscle; Healthcare Systems; Hirudin; Hirudins; Histology; Human; Human, General; Hydrogen Oxide; Hydrogen Peroxide; Hydrogen Peroxide (H2O2); Hydroperoxide; IACUC; IHC; Immune; Immunohistochemistry; Immunohistochemistry Staining Method; Implant; In Vitro; Institutional Animal Care and Use Committee; LLNA; Label; Lasers; Length; Life; Local Lymph Node Assay; Lytotoxicity; Man (Taxonomy); Man, Modern; Marrow platelet; Measures; Mechanics; Mediating; Medical Device; Methods; Microscopy; Mimetics, Biological; Modality; Modeling; Modification; Molecular Interaction; Monitor; Morphology; Muscle Rigidity; Muscle, Involuntary; Muscle, Smooth; Negative Beta Particle; Negatrons; Operation; Operative Procedures; Operative Surgical Procedures; Outcome; Ovis; Oxirane; Patients; Peptides; Performance; Peripheral arterial disease; Permeability; Persons; Phase; Phase 1 Clinical Trials; Phase I Clinical Trials; Phase I Study; Platelets; Play; Polymers; Porosity; Pressure; Pressure- physical agent; Procedures; Process; Property; Property, LOINC Axis 2; Prosthesis; Prosthetic device; Prosthetics; Proteins; Protocol; Protocols documentation; Pyrogens; QOL; Quality of life; R & D; R&D; Radial; Radiation, Laser; Radio; Relative; Relative (related person); Reproducibility; Research; Reticuloendothelial System, Blood; Reticuloendothelial System, Platelets; Rigidity; Rigidity, Muscular; Role; Rotation; SBIR; SBIRS (R43/44); Safety; Saline; Saline Solution; Sample Size; Sampling; Scanning; Sheep; Side; Small Business Innovation Research; Small Business Innovation Research Grant; Smooth muscle (tissue); Societies; Spectroscopy; Spectrum Analyses; Spectrum Analysis; Speed; Speed (motion); Staining method; Stainings; Stains; Steam; Sterilization; Sterilization for infection control; Structure; Substrates, Chromogenic; Surface; Surgical; Surgical Interventions; Surgical Procedure; Surgical sutures; Sutures; Systems, Health Care; TXT; Technology; Tensile Strength; Testing; Text; Thick; Thickness; Thrombase; Thrombin; Thrombocytes; Thrombosis; Thrombus; Toxic effect; Toxicities; United States; V (voltage); Variant; Variation; Vascular Graft; Vascular Prosthesis; Visual; Water; Weight; Weight Loss; Weight Reduction; advanced age; base; biocompatibility; biomaterial compatibility; body weight loss; cell assembly; chemical property; covalent bond; cytotoxicity; design; designing; digital; disease/disorder; economic impact; elders; experiment; experimental research; experimental study; fibrinogenase; gene product; genotoxicity; geriatric; implantation; improved; in vitro Model; in vitro testing; in vivo; innovate; innovation; innovative; irritation; late life; later life; manufacturing scale-up; meetings; nano fiber; nano meter; nanofiber; nanofibrous; nanometer; older adult; older person; particle; phase 1 study; phase 1 trial; phase I trial; physical property; pressure; protocol, phase I; prototype; public health relevance; regenerate new tissue; regenerating damaged tissue; research and development; research study; response; scaffold; scaffolding; senior citizen; social role; success; surgery; thrombocyte/platelet; tissue regeneration; vascular; voltage; wt-loss

In this Fast Track SBIR application, NanoVasc (Alameda, CA) plans to use its proprietary and innovative electrospinning process (initially developed at U.C. Berkeley in Dr. Song Li's Lab) to develop small diameter vascular grafts (called NanoGrafts) for the treatment of Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). NanoVasc's innovation is the development of a small diameter vascular graft (3-5mm internal diameter) using a biomimetic scaffold that is both biodegradable and bioactive. This research shows great promise for the field of vascular bypass surgeries, as the structure and morphology of electrospun, nanofibrous scaffolds can be manipulated to resemble that of natural extracellular matrix (ECM), therefore creating a more "familiar" environment for the cells to migrate into. The company has preliminary evidence showing the performance and remodeling of a 1mm internal diameter, nanofibrous vascular grafts in vivo with very encouraging results. This project will focus on developing small diameter grafts, evaluating their physico-chemical properties, biological and hemo-compatibility and platelet/thrombus interactions in vitro, and then evaluating their biocompatibility and in vivo dynamics, compatibility/patency and safety in a sheep model. In Phase I, polymer selection, surface modification, and mechanical integrity will be investigated. The candidates that pass the given criteria will then be tested for thrombogenicity, biological and hemo-compatibility using an in vitro blood recirculation loop. Phase II will focus on the in vivo patency in a sheep bilateral common carotid artery model for 28 and 140 days. Controls will include commercially available, 4mm ePTFE vascular grafts.

Public Health Relevance:
The quality of life for millions of Americans is impacted severely from the suffering associated with atherosclerotic vessel disease, especially the elderly. Research and development of a vascular conduit like the NanoVasc graft will play a key role in not only improving the quality of these patients' lives by providing better treatment options/modalities but also reduce the economic impact on the society as a whole and patients in particular. A vascular prosthesis that far exceeds the results of today's treatment options will positively affect the United States' health care system.

Thesaurus Terms:
Acute; Adhesions; Affect; Aged 65 And Over; American; Amines; Animals; Assay; Bilateral; Binding; Binding (Molecular Function); Bioassay; Biocompatible; Biodegradation; Biologic Assays; Biological; Biological Assay; Biomimetics; Bizzozero's Corpuscle/Cell; Blood; Blood Platelets; Blood Vessel Prosthesis; Blood Vessels; Body Weight Decreased; Bypass; Caliber; Carotid Arteries; Cell-Extracellular Matrix; Cell/Tissue, Immunohistochemistry; Cells; Certification; Characteristics; Chemicals; Chromogenic Substrates; Chronic; Clinical; Common Carotid Artery; Coronary Arteriosclerosis; Coronary Artery Disease; Coronary Artery Disorder; Coronary Atherosclerosis; Deetjeen's Body; Deposit; Deposition; Development; Development And Research; Diameter; Dimensions; Disease; Disorder; Ecm; Elderly; Elderly, Over 65; Electromagnetic, Laser; Electrons; Embolism; Embolus; Ensure; Environment; Esthetics; Ethylene Oxide; Evaluation; Exhibits; Extracellular Matrix; Fiber; Generations; Glycolates; Goals; Government; Guidelines; H2o2; Hayem's Elementary Corpuscle; Healthcare Systems; Hirudin; Hirudins; Histology; Human; Human, General; Hydrogen Oxide; Hydrogen Peroxide; Hydrogen Peroxide (H2o2); Hydroperoxide; Iacuc; Ihc; Immune; Immunohistochemistry; Immunohistochemistry Staining Method; Implant; In Vitro; Institutional Animal Care And Use Committee; Llna; Label; Lasers; Length; Life; Local Lymph Node Assay; Lytotoxicity; Man (Taxonomy); Man, Modern; Marrow Platelet; Measures; Mechanics; Mediating; Medical Device; Methods; Microscopy; Mimetics, Biological; Modality; Modeling; Modification; Molecular Interaction; Monitor; Morphology; Muscle Rigidity; Muscle, Involuntary; Muscle, Smooth; Negative Beta Particle; Negatrons; Operation; Operative Procedures; Operative Surgical Procedures; Outcome; Ovis; Oxirane; Patients; Peptides; Performance; Peripheral Arterial Disease; Permeability; Persons; Phase; Platelets; Play; Polymers; Porosity; Pressure; Pressure- Physical Agent; Procedures; Process; Property; Property, Loinc Axis 2; Prosthesis; Prosthetic Device; Prosthetics; Proteins; Protocol; Protocols Documentation; Pyrogens; Qol; Quality Of Life; R & D; R&D; Radial; Radiation, Laser; Radio; Relative; Relative (Related Person); Reproducibility; Research; Reticuloendothelial System, Blood; Reticuloendothelial System, Platelets; Rigidity; Rigidity, Muscular; Role; Rotation; Sbir; Sbirs (R43/44); Safety; Saline; Saline Solution; Sample Size; Sampling; Scanning; Sheep; Side; Small Business Innovation Research; Small Business Innovation Research Grant; Smooth Muscle (Tissue); Societies; Spectroscopy; Spectrum Analyses; Spectrum Analysis; Speed; Speed (Motion); Staining Method; Stainings; Stains; Steam; Sterilization; Structure; Surface; Surgical; Surgical Interventions; Surgical Procedure; Surgical Sutures; Sutures; Systems, Health Care; Txt; Technology; Tensile Strength; Testing; Text; Thick; Thickness; Thrombase; Thrombin; Thrombocytes; Thrombosis; Thrombus; Toxic Effect; Toxicities; United States; V (Voltage); Variant; Variation; Vascular Graft; Vascular Prosthesis; Visual; Water; Weight; Weight Loss; Weight Reduction; Advanced Age; Base; Biocompatibility; Biomaterial Compatibility; Body Weight Loss; Cell Assembly; Chemical Property; Covalent Bond; Cytotoxicity; Design; Designing; Digital; Disease/Disorder; Economic Impact; Elders; Experiment; Experimental Research; Experimental Study; Fibrinogenase; Gene Product; Genotoxicity; Geriatric; Implantation; Improved; In Vitro Model; In Vitro Testing; In Vivo; Innovate; Innovation; Innovative; Irritation; Late Life; Later Life; Manufacturing Scale-Up; Meetings; Nano Fiber; Nano Meter; Nanofiber; Nanofibrous; Nanometer; Older Adult; Older Person; Particle; Phase 1 Study; Physical Property; Pressure; Prototype; Public Health Relevance; Regenerate New Tissue; Regenerating Damaged Tissue; Research And Development; Research Study; Response; Scaffold; Scaffolding; Senior Citizen; Social Role; Success; Surgery; Thrombocyte/Platelet; Tissue Regeneration; Vascular; Voltage; Wt-Loss