Clinical Development of Non-compressible Hemostatic Agent for High-Volume Hemorrhage

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL086293-04A1
Agency Tracking Number: R44HL086293
Amount: $1,982,696.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA14-077
Timeline
Solicitation Year: 2017
Award Year: 2012
Award Start Date (Proposal Award Date): 2012-03-15
Award End Date (Contract End Date): 2015-07-31
Small Business Information
760 Parkside Ave., #304, Brooklyn, NY, 11226-1508
DUNS: 146587345
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: Y
Principal Investigator
 MAJA NOWAKOWSKI
 (718) 270-2749
 maja.nowakowski@downstate.edu
Business Contact
 GEORGE FALUS
Phone: (917) 822-5552
Email: gfalus@biomedic.net
Research Institution
N/A
Abstract
DESCRIPTION provided by applicant andquot ClotFoam R andquot is a novel adhesive sealant composition and second generation hemostatic agent This biological agent was designed to arrest moderate to severe blood loss arising from intracavitary traumatic injury or intraoperative hemorrhage without compression stitches or staples Control of Intraoperative hemorrhage in laparoscopic surgery which is increasingly becoming a suitable alternative to open surgery can be extremely difficult and often results in conversion to open laparotomy Intraoperative hemorrhage during liver resection and other laparoscopic procedures remain a major risk which affects both immediate and long term results There is no available non compressible product to control hemorrhage in cases of high volume intraoperative bleeding in laparoscopic procedures Therefore a non compressible hemostatic control in laparoscopic surgery will result in reduction of blood loss postoperative pain hospital stay and complications following these procedures Also there are no available hemostatic products for use in trauma outside the operating room Hemorrhage resulting from traumatic injuries is a major cause of death in accidents and the primary cause of death on the battlefield Over of the trauma cases admitted at hospitals in the United States is due to road traffic accidents Hemorrhage is the primary cause of death on the battlefield in conventional warfare The vast majority of these deaths occur before the injured can be transported to a treatment facility Tissue adhesives and sealants have been developed to control bleeding but since all existing haemostatic agents for abdominal intracavitary bleeding are designed to be used in the operating room not in an emergency at the site of accident or in the battlefield hemorrhage is often fatal With early and effective hemorrhage control more lives can be saved than by any other measure Proof of concept studies supported by the National Heart Lung and Blood Institute and by the Department of Defense DARPA and the U S Army in the swine model have established the remarkable sealing properties of the agent ClotFoam employs a new technology that bypasses the traditional mixture in situ of thrombin and fibrinogen which translates in greater clotting efficacy and safety The agentandapos s competitive advantages over available technologies include a wide range of applications and uniqueness for use in cases of high volume bleeding and its rapid effect ClotFoam R is also a plasmin depleted aprotinin and thrombin free fibrin sealant presenting no risk of autoimmune reaction to blood products ClotFoamandapos s fibrin components can be stored in a refrigerator at C ready to use There is no need to unfreeze mix or dissolve the components Unlike other fibrin sealants it does not present a risk of thrombin self cleavage and fibrinogen proteolytic degradation which can severely reduce the efficacy of the agent over time Its production costs are much lower than available fibrin sealants GLP preclinical studies by the National Heart Lung and Blood Institute have compared the hemostastic effect of ClotFoam against GelFoam Pfizer without compression or sutures in three surgical protocols producing moderated to severe venous and arterial bleeding The study has established the efficacy and safety of the agent and produced the necessary data to submit an Investigational New Drug Application IND to the Food and Drug Administration toward the conduction of clinical trials The goal of this project is to conduct clinical trials with the non compressible hemostatic agent ClotFoam R as required by the Food and Drug Administration FDA for advancing the development of the sealant toward Biologic License as a general hemostatic The research strategy to obtain approval for ClotFoam R as a general non compressible hemostatic agent is to establish efficacy and safety in three distinct protocols that cover different body organs and tissues as well as applications These protocols include laparoscopic partial nephrectomy laparoscopic liver resection and post traumatic hemodynamically stable and non coagulopathic spleen laceration Significance The proposed technology will significantly improve the treatment of civilian and military trauma injuries related to peritoneal hemorrhage allow safe evacuation of the injured to definitive care centers and reduce casualties of combat It will allow for expanding the use of minimally invasive surgical procedures and provide a method to stop bleeding in laparoscopic surgery ClotFoam R could have an important impact in emergency medicine trauma and surgery as well as a substantial share of the $ billion a year U S projected market for second generation surgical sealants The core fibrin component technology developed by our company could be used by other surgical sealant and wound healing products manufacturers considerably expanding the option for the treatment of blood loss and wound healing Substantial economic activity will be generated from the global provision of this core component ClotFoam R is a novel adhesive sealant composition designed to stop moderate to severe blood loss arising from traumatic injury or intraoperative hemorrhage without need of compression Achieving hemostasis as primary treatment without need of compression is essential for treating traumatic wounds and facilitates the use of laparoscopic procedures The control of hemorrhage in laparoscopic surgery which is increasingly becoming a suitable alternative to open surgery can be extremely difficult and it often results in conversion to open surgery This technology addresses important unmet needs as there are no available products to control hemorrhage in cases of high volume intraoperative bleeding without the use of compression A non compressible hemostatic control in laparoscopic surgery will result in the reduction of blood loss postoperative pain hospital stay and complications following these procedures Nor are there available such hemostatic products for use in trauma outside the operating room Hemorrhage resulting from traumatic injuries is a major cause of death in accidents and the primary cause of death on the battlefield Over of the trauma cases admitted at hospitals in the United States is due to road traffic accidents The vast majority of these deaths occur before the injured could be transported to a treatment facility Various types of tissue adhesives and sealants have been developed to control bleeding but none of approved sealants are designed to be used as primary treatment without need of sutures or stitches or in cases of moderate to severe bleeding All existing haemostatic agents for abdominal intracavitary hemorrhage have been developed for minor bleeding in the operating room not in an emergency at the site of accident or in the battlefield where hemorrhage is often fatal With early and effective hemorrhage control more lives can be saved than by any other measure The agent ClotFoam has remarkable sealing properties and competitive advantages over available technologies Unlike other fibrin sealants it is effective as a primary treatment and reduces the use of sutures saving time and facilitating minimally invasive surgical procedures The agent does not present a risk of immunological reactions it is safe and its production costs are lower The goal of the project is to conduct clinical trials with the novel hemostatic agent ClotFoam as required by the Food and Drug Administration FDA for advancing the development of ClotFoam toward Biologic License as a general hemostatic The strategy to obtain approval for ClotFoam as a general non compressible hemostatic agent is to establish its efficacy and safety in three distinct protocols that cover different body organ and tissues as well as in applications The proposed technology will significantly improve the treatment of trauma injuries related to peritoneal hemorrhage allow safe evacuation of the injured to definitive care centers and reduce casualties of combat It will allow for expanding th use of minimally invasive surgical procedures and provide a method to stop bleeding in laparoscopic surgery ClotFoam can have an important impact in emergency medicine trauma and surgery as well as a substantial share of the $ billion per year estimated for second generation surgical sealants in the U S market Substantial income and economic activity will be generated by the technology as well of the core fibrin component which could be used by other fibrin sealants and wound product manufacturers all over the world

* Information listed above is at the time of submission. *

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