Endomedix, Inc. — Department of Health and Human Services SBIR Phase II: NINDS

Description

DESCRIPTION provided by applicant Bleeding control during brain surgery is of utmost importance as uncontrolled bleeding inside the confined intracranial space can quickly degenerate into debilitating complications and death Ligature is usually not possible in the brain due both to the small size of the vessels and the delicacy of the tissue as the majority of bleedings during neurosurgery is the topical diffuse oozing type bleeding The methods for bleeding control during brain surgery has practically not changed for decades surgical aids that work by pressure absorption and or chemical mediated mechanisms are deployed for hemostasis during brain surgery The shortcomings of these products include i require preparation ii non conformal non adhesive to the surgical site iii require manual pressure iv lack transparency limited capacity to visualize the hemostasis status v materials of bloo and or mammalian origin risk of disease transmission and v swelling Importantly the major inadequacies of these products are slow acting leading to prolonging surgery risk and morbidity and often produce inconsistent results Gelatin foam saturated with thrombin solution in conjunction with applying pressure is still the current gold standard to stop diffuse bleeding the process requires a coordinated deployment of at least four products including gelatin foam thrombin cottonoids and suction We are developing a non mammalian non blood derived biocompatible and biodegradable in situ gelable adhesive formable conformable and non swelling transparent hydrogel that requires no preparation for cranial hemostasis it is non chemically mediated and can quickly stop bleeding on contact without any adjuncts A transparent agent capable of achieving hemostasis rapidly enables the surgeons to determine the status of hemostasis and speed up the decision of moving onto the next step of the surgery Accelerating surgery with a highly competitively priced hemostatic agent will eventually result in considerable cost saving on operating room time and reduction of morbidity through shortening of surgery and general anesthesia Our product conforms to the new healthcare economics where insurers are increasingly demanding superior products at lower costs A prototype agent was developed in the Phase I of this project and its efficacy and performance criteria have been experimentally defined In Phase II we will continue to develop the hemostat product The major goals are i reduce the product endotoxin burden to comply with FDAandapos s requirement ii maximize the productandapos s consistency iii streamline the current methodologies to reduce the future production costs iv develop a non power assisted dispenser for the product to facilitate clinical use v production of GLP grade materials vi ISO biocompatibility and toxicology validation and vii in vivo pilot testing of the hemostat in a large animal cranial model PUBLIC HEALTH RELEVANCE Brain is highly vascularized and all surgeries disrupt its delicate vasculature Topical diffuse oozing type bleedings are common during brain surgery many hemostatic agents currently used clinically in brain surgery are off label uses The methods for bleeding control during brain surgery has practically not changed for many decades thrombin solution soaked gelatin foam is still the current gold standard to stop diffuse bleeding the entire process requires a highly coordinated deployment of at least four products including gelatin foam and thrombin which are blood animal derived products The goal of this project is to develop a non mammalian and non blood derived biocompatible and biodegradable in situ gelable adhesive formable conformable and non swelling transparent hydrogel that requires no preparation for hemostasis during brain surgery that quickly stops bleeding on contact without any adjuncts and it is not chemically mediated Through shortening of surgery and reducing general anesthesia the product will reduce post surgical morbidity and is also highly competitively priced importantly its speedy action will lead to substantial reduction in operating room time thus cost saving at least minutes per case at $ minute of operating room cost for a total of $ which will eventually result in considerable cost saving in multiple fronts of the healthcare system