IT Clamp 50 Transforming the Field of Emergency Trauma Care The IT Clamp 50 device requires CE Mark clearance. Not currently available for sale in Europe.
PROBLEM: Hemorrhage, or severe bleeding, is the leading cause of preventable death in traumatic injuries. Blunt force trauma (car accidents) Penetrating wounds (gun, knife) Battlefield injuries Junctional hemorrhage sustained in the course of combat operations is recognized as a leading cause of mortality in the current conflict in Afghanistan. US Defense Health Board, 2011 2
Injured People are Dying Needlessly Battlefield Injuries Hemorrhage is the leading of preventable death 5% of US soldiers died of junctional bleeding Civilian Trauma Leading cause of death in first decades of life >7M trauma patients in Europe Blunt (car accidents) & Penetrating (accidents, gun, knife) EU Economic Impact of Injuries Hospital Discharges: 1,5/100.000 population Hospital Days: 60 million per year Deaths: >200.000 per year 3
Current solutions aren t really solutions The same technology has been used for thousands of years Direct pressure Tourniquets Gauze for packing wounds Hemostatic (clotting) agents 4
Current solutions present challenges TIME challenge: current solutions take anywhere from 5-15 minutes to apply. ANATOMY challenge: current device solutions can not address junctional areas like groin or armpits. PAIN challenge: current solutions are painful for injured. FLOW challenge: current solutions cut off blood flow to entire extremity, leading to potential health issues beyond point of injury. USAGE challenge: current solutions require medical knowledge. 5
Elegantly Simple - Instant Results The IT Clamp 50 device requires CE Mark clearance. Not currently available for sale in Europe. 6
The IT Clamp 50 device requires CE Mark clearance. Not currently available for sale in Europe.
FAST: stops bleeding in under 5 seconds. EFFECTIVE: pre-clinical trials show significant improvement in survival, survival time and blood loss. EASY: any one can use; intuitive and can be self applied. APPLY ANYWHERE: can be used in junctional areas, scalp, face with one or multiple devices. PAIN: brief needle poke. Hemorrhage Control System SELECTIVE CONTROL: stops bleeding at point of injury but allows flow to distal extremity. The IT Clamp 50 device requires CE Mark clearance. Not currently available for sale in Europe.. 8
Who Can Use? 1. First Responders (EMS, police) 2. Militaries (soldiers, medics) 3. Emergency Departments/Trauma Bays/Operating Rooms The IT Clamp 50 device requires CE Mark clearance. Not currently available for sale in Europe. 9
Clinical Evidence
ITClamp Pre-Clinical Trials: Aug 2011 Life threatening hemorrhagic swine model Complex femoral artery/vein laceration 4 arms (5 subjects in each arm): Control (no treatment) Standard gauze (delayed treatment 3 min) ITClamp (early treatment 10 sec) ITClamp (delayed treatment 3 min) Primary endpoints: volume of blood loss and mortality
ITClamp Pre-Clinical Trials: Aug 2011
ITClamp Pre-Clinical Trials: Aug 2011 No statistical difference observed in the wound dimensions or skin thickness. Pathology of skin captured by the ITClamp showed no histologic changes compared to controls or standard gauze groups.
FAQ s Q: Does the ITClamp hurt to apply? A: After a brief needle poke, ITClamp does not cause pain (or damage the skin in anyway). Q: How long can the ITClamp be left on? A: Pre-clinical testing showed safety at 3 hours. It is intended for temporary closure. Times in excess of 12-24 hours carry an elevated risk of infection when placed on a contaminated wound. Q: Does the ITClamp come in multiple sizes? A: No. Current size is easily handled. Larger wounds can be closed by multiple devices in series. Q: When will it be available? A: Non-sterile versions are available. Product launch in Q1 2013. The IT Clamp 50 device requires CE Mark clearance. Not currently available for sale in Europe..
Summary Unmet Medical Need immediate control of critical external bleeding including junctional bleeds. Easy to use and carry Portable, light weight, effective, intuitive. Effective Pre-clinical trial validation of junctional bleeding Aug 2011. Product launch Q1 2013. Low end user cost $70 USD. Long term potential future products in development to extend point of injury solutions with novel technologies. The IT Clamp 50 device requires CE Mark clearance. Not currently available for sale in Europe. 15