Endoshape, Inc. was awarded a $370,938 project grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health to develop radiopaque shape memory polymers for neurovascular embolotherapy applications. The Cardiovascular Diseases Research program aims to support heart and vascular research, including through competitive research training grants. Under this award, Endoshape will develop new radiopaque shape memory polymer materials incorporated into embolic coils....
This Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS), under the Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853) program, provides $1,386,770 to VON Vascular, Inc. to develop a novel aspiration pump for neurointerventional procedures. The goal is to create an improved aspiration pump that can increase first-pass revascularization rates and reduce medical waste, compared to existing market-leading devices....
This $274,547 Project Grant awarded by the National Science Foundation (NSF) under the NSF Technology, Innovation, and Partnerships (CFDA 47.084) program aims to develop a novel Aneurysm Sealing Device (ASD) for endovascular treatment of Abdominal Aortic Aneurysms (AAA). The project seeks to create a device that can completely seal the aneurysm sac, reducing the risk of post-procedure complications and the need for repeat interventions. Key objectives include validating the device's adaptability...
This $490,049 Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS), under the Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853) program, supports research by Shearit LLC to evaluate the efficacy of their Lamiflo drug for reducing ischemic penumbra and core volumes in acute ischemic stroke. The 1-year study will test Lamiflo, a drag-reducing polymer that enhances blood flow, in rat models of middle cerebral artery...
This National Science Foundation (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) Project Grant of $275,000 awarded to Xtract Medical Inc. aims to develop and demonstrate the feasibility of a novel catheter-based system for improved removal of blood clots during mechanical thrombectomy procedures to treat venous thromboembolism (VTE). The proposed system is designed to effectively remove large blood clots while minimizing damage to blood vessels and reducing complications such as...
F Square Medical LLC received a $880,668 Project Grant from the National Eye Institute of the National Institutes of Health, Department of Health and Human Services under the Vision Research federal grant program (CFDA 93.867) for the period of September 1, 2021 through August 31, 2022. The funding will support F Square Medical's development of the first-ever safe and effective anterior chamber paracentesis instrument to treat and diagnose ocular diseases. Specifically, the company will refine...
This $252,906 National Science Foundation project grant supports the development of scalable manufacturing methods for peptide amphiphile molecules by Amphix Bio Inc. The goal is to advance a safer and more affordable alternative to recombinant proteins currently used in spinal fusion surgeries. Over 500,000 such surgeries are performed annually in the U.S. to treat back and neck pain. While peptide amphiphiles show promise for reducing biological dose needs and offering consistent outcomes,...
This Project Grant award from the National Heart, Lung, and Blood Institute (CFDA 93.837 Cardiovascular Diseases Research program) provides $618,912 to Dynaflow, Inc., a minority-owned small business, to develop a numerical platform for modeling microbubble-enhanced sonothrombolysis. The platform aims to accelerate the clinical deployment of this non-invasive ultrasound treatment for thrombosis, a leading cause of death and disability. Key objectives include incorporating viscoelastic clot...
This Project Grant award from the National Cancer Institute (CFDA 93.395 - Cancer Treatment Research) provides $857,315 to Creosalus Inc. to conduct a first-in-human clinical study evaluating the safety and efficacy of the company's Porous Brain Infusion Catheter (PBIC) system for convection-enhanced delivery of therapeutics to recurrent Grade 3-4 glioma patients. The primary objective is to assess the PBIC's safety profile and its ability to achieve significantly greater coverage of enhancing...
This National Science Foundation (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) Cooperative Agreement award of $1,000,000 to Theromics Inc., a minority-owned small disadvantaged business, aims to develop a novel protein-based gel to improve the effectiveness and safety of thermal tumor ablation procedures. The project will involve creating a computational model to predict the thermal behavior of the gel, conducting preclinical studies to quantify temperatures, ablation zone size,...
FLOW RESPONSIVE EMBOLIC AGENT FOR THE COMPLETE DEVASCULARIZATION OF MENINGIOMAS - PROJECT SUMMARY SIGNIFICANCE: PRE-OPERATIVE EMBOLIZATION (POE) OF MENINGIOMAS IS AN ESTABLISHED NEUROENDOVASCULAR PROCEDURE PERFORMED TO REDUCE THE EXTENSIVE AMOUNT OF BLOOD LOSS THAT OCCURS DURING TUMOR RESECTION. THE CURRENT PRACTICE IS SIGNIFICANTLY HAMPERED BECAUSE OF EFFICACY AND SAFETY DEFICIENCIES OF CURRENT EMBOLIC AGENTS USED OFF-LABEL FOR THIS INDICATION (NONE OF WHICH ARE DESIGNED SPECIFICALLY FOR POE). POLYVINYL ALCOHOL PARTICLES ARE THE MOST USED EMBOLIC AGENT, BUT EFFICACY DATA RAISE CONCERNS OF THEIR CLINICAL BENEFIT. TRUFILL AND ONYX ARE LIQUID-BASED EMBOLIC ALTERNATIVES BUT ARE FRAUGHT WITH LIMITATIONS OF THEIR OWN. FOR EXAMPLE, ONYX CONTAINS TOXIC SOLVENT THAT CAUSES PATIENT PAIN AND DISCOMFORT WHILE THE TECHNICAL RISKS ASSOCIATED WITH TRUFILL HAVE NEGATED ITS WIDE-SPREAD ADOPTION IN THE UNITED STATES. THUS, THERE IS A NEED FOR AN EASY-TO-USE, ON-LABEL EMBOLIC AGENT DESIGNED SPECIFICALLY FOR POE OF MENINGIOMAS THAT PROVIDES SAFE AND COMPLETE DEVASCULARIZATION. SUCH AN EMBOLIC WOULD RESULT IN FASTER AND SAFER SURGICAL RESECTION, REPRESENTING A SIGNIFICANT EVOLUTION IN THE TREATMENT OF MENINGIOMA PATIENTS. APPROACH: IN THIS DIRECT TO PHASE II SBIR, ARSENAL MEDICAL WILL ADVANCE ITS SHEAR-THINNING BIOMATERIAL TECHNOLOGY, A FLOW RESPONSIVE EMBOLIC (FRE) AGENT, AS A THERAPY FOR THE POE OF MENINGIOMAS. FOR POE TO BE EFFECTIVE, COMPLETE DEVASCULARIZATION OF THE MENINGIOMA IS DESIRED, WHICH IS ACHIEVED BY TOTAL OCCLUSION OF ALL DISTAL VESSELS THAT SUPPLY THE TUMOR. OUR PHASE I RESULTS HAVE DEMONSTRATED THAT THE FRE EXHIBITS SUPERIOR DISTAL PENETRATION COMPARED TO COMMERCIAL LIQUID EMBOLICS, IS BIOCOMPATIBLE, AND CAN BE MANUALLY INJECTED THROUGH A NEUROVASCULAR MICROCATHETER. THE GOAL OF THIS PROPOSAL IS TO ADVANCE THE PROOF-OF-CONCEPT FORMULATION TOWARDS A PRODUCT CONFIGURATION THAT IS READY FOR CLINICAL TESTING VIA AN EARLY FEASIBILITY STUDY (EFS), ENABLING AN EFFICIENT PATH TO COMMERCIALIZATION. IN AIM 1, WE WILL FINALIZE THE DELIVERY SYSTEM AND AFFIRM THE PRODUCT'S USABILITY WITH CLINICIANS. AIM 2 WILL CONSIST OF SELECTION OF A COMMERCIALLY VIABLE STERILIZATION METHOD, FOLLOWED BY CONFIRMATION OF PRODUCT SHELF-LIFE. BIOCOMPATIBILITY OF THE FRE WILL BE CONFIRMED VIA A PRE-CLINICAL STUDY TO DETERMINE THE NEUROVASCULAR RESPONSE AND SAFETY (AIM 3) AND ISO10993 BIOCOMPATIBILITY TESTING THROUGH BIOLOGICAL AND CHEMICAL CHARACTERIZATION ASSAYS (AIM 4). THE PROPOSED WORK PROVIDES A FOUNDATIONAL DATA SET THAT WILL BE COMPLEMENTED WITH POST-PHASE II ACTIVITIES TO ADVANCE TOWARDS COMMERCIALIZATION. INNOVATION: THE FRE BIOMATERIAL HAS ADAPTIVE PROPERTIES ENABLING IT TO BECOME A LOW VISCOSITY FLUID UNDER HIGH SHEAR THAT PENETRATES AND FILLS THE DISTAL VESSELS SUPPLYING THE MENINGIOMA. AS EMBOLIZATION PROGRESSES, FLOW AND SHEAR WILL CONTINUALLY DECREASE; IN RESPONSE, THE FRE PROGRESSIVELY INCREASES IN VISCOSITY BECOMING A VISCOUS PASTE FOR CONTROLLED INJECTION. THE RESULT IS COMPLETE CASTING AND OCCLUSION OF THE ENTIRE VASCULATURE. COMPARED TO OTHER LIQUID EMBOLICS, THE FRE IS LESS SUSCEPTIBLE TO INCOMPLETE OCCLUSION BECAUSE ITS SOLIDIFICATION MECHANISM OCCURS INDEPENDENT OF ITS MICROENVIRONMENT. ONYX, FOR EXAMPLE, SOLIDIFIES VIA A PRECIPITATION EFFECT, FORMING A HARD OUTER SHELL THAT CAN BLOCK VESSEL BRANCH PATHWAYS PREVENTING THEM FROM DEEP VESSEL EMBOLIZATION.