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Hem. Con Overview & Training
Agenda • Introductions • Company Background • Breadth of Hem. Con Products & Usage Models • Opportunities • Training
Corporate Foundation Hem. Con Medical Technologies, Inc. was founded on one simple premise. SAVE LIVES.
ilestones U. S. Army ISR Lyophilized Plasma Program Awarded ─ Cardinal Health Exclusive Ambulatory Distribution Relationship ─ 2007 Awarded $3. 5 mm by U. S. government to develop burn and surgical dressing ─ Received FDA clearance for Hem. Con Dental Dressing ─ Completed 22, 000 square ft expansion of manufacturing 2006 facility ─ Initiative from Army Surgeon General to supply all U. S soldiers with Hem. Con Bandage ─ Appropriated $10. 5 mm for product procurement 2005 2004 and R&D ─ ─ Appropriated $8. 7 mm US government contract to 2003 expand R&D mfg capability ─ Bandage receives FDA clearance in 48 hours – 2 nd fastest in US history 2002 2001 ─ Awarded initial U. S. Army Contract ─ April - 4 x 4 dressing developed by OMLC with funding from US Army ─ Hem. Con founded under license to OMLC and Providence Health to develop and manufacture the chitosan dressing
Proprietary Technology Chitosan – positively charged Attractive Product Features • Red blood cells / platelets – negatively charged Works independently of the clotting cascade • No adverse reactions reported to date (>500, 000 units shipped) Antibacterial barrier • Ø Quickly creates a clot and seals wound • • Ø Chitosan bandage draws red blood cells / platelets to the surface Quickly stops severe hemorrhage in a variety of settings – typically within 2 -5 minutes Effective in patients taking anticoagulant medications • Easily removed without dislodging the clot
Hem. Con Dressings Revolutionary hemostatic dressings providing: – Rapid control of moderate to severe external (arterial) hemorrhaging – Antibacterial seal to promote healing – No adverse affects reported to date – Multiple usage models per size and shape
Hem. Con Saves Lives – – Hem. Con Bandages have saved over one hundred lives in Iraq and Afghanistan Mandated by the Surgeon General that all deployed US Army carry at least one Hem. Con Bandage Reported 97% effective in the battlefield by US Army Surgeon General UK Surgeon General reports – “number of seriously injured troops dying has dropped from 24% to just 13%” "They have resulted in a survival rate that's better than anybody has ever achieved. “ UK Surgeon General, Lieutenant General Louis Lillywhite
Hem. Con – Recent Coverage • • Reader’s Digest USA Today National Geographic CNN (360 with Anderson Cooper) CNN. com Fortune Small Business Inc 500 Ranking - 219 Deloitte Fast 50 Ranking - 42
Current Hem. Con Product Portfolio Hem. Con Bandage Chito. Flex Dental Available January 2008
Hem. Con – Hospital • • ER / Trauma centers treat 6 to 7 million bleeding wounds annually Standardized solution across departments: – – • Emergency Department Trauma Centers Surgical Suites Interventional Radiology, Catheterization Labs Managing Bleeding from: – Acute wounds – Multiple trauma issues – Severe bleeding / damage control • Exclusive relationship with Cardinal brings Hem. Con Bandages to over 50% of the hospitals in the US
Catheterization Lab • Success in Cath labs in Italy and Israel • Clinical study in Israel to provide data • Early success and testing at: – Central Baptist – Duke University Medical Center – Madigan
Select Hospital Penetration • • • Central Baptist Hospital* Christiana Hospital Cleveland Clinic* Colorado Heart Institute* Duke University Hospital Falmouth Hospital Grant Medical Center Hackettstown Regional Medical Center* Medical University of South Carolina* Mercy Medical Center Metro. Health Medical Center Newton-Wellesley Hospital* • • • Northwestern Memorial Hospital Ohio State University Medical Center East* Rehabilitation Hospital of Indiana* Rush University Medical Center* St. Agnes Hospital* St. Elizabeth's Medical Center St. Francis Hospital* University of North Carolina Memorial Hospital University of Pittsburgh Medical Center, Shadyside* Vanderbilt Medical Center* Weirton Medical Center* * Products used in the Cardiac Catheterization Laboratory as well as in the Trauma and Emergency Departments.
Hem. Con – Prehospital Care • Successfully used by Tualatin Valley F & R • Piloted by David Shield (Israeli Red Cross) – 13 life-saving uses “The limited experience suggests the Hem. Con Bandage can be successfully incorporated into the civilian EMS system. When properly applied, the Hem. Con Bandage stops uncontrolled external hemorrhage when conventional methods fail. ” “This report on the field use of the - Medicine & Critical Care Review 2006 Hem. Con dressing by medics suggests that it is a useful hemostatic dressing for prehospital combat casualties and supports further study to confirm efficacy. ” Journal of Trauma March 2006
Hem. Con – Dental Market • 42 million extractions/year in the United States; also useful for oral surgeries, grafts & periodontal procedures • Rapid oral wound protection, allows for decreased time in the chair for patient – 10 mm x 12 mm for extractions – 1 in x 3 in for periodontal and oral surgeon market
Hem. Con – OTC • 10 million consumers on anticoagulation medications - 50 million on aspirin therapy • 1% of population with von Willebrand’s disease or hemophilia • Prevent a trip to the emergency room - Hem. Con should be in every first aid kit • Marketed through pharmacies, hemodialysis clinics & physicians • Secondary markets - Home/recreational/industrial safety • Launched January 2008 in USA
Hem. Con – Wound Care “The data suggest that chitosan acetate rapidly kills bacteria in the wound before systemic invasion can take place, and is superior to alginate bandage and silver sulfadiazine that may both encourage bacterial growth in the short term. ” Biomaterials 27 (2006) 4157 -4164 Frost & Sullivan Reports the global advanced wound care market to be $1. 5 billion in 2004, growing to $3. 12 billion in 2009.
Usage Information • The bandage can be cut into smaller pieces to fit into small wounds, or multiple bandages can be overlapped for large injuries. • The bandage must be in contact with the bleeding vessel to be effective. • Apply and maintain pressure for at least two minutes or until bleeding is controlled. • The bandage should be wrapped with gauze or a pressure dressing for transport. • Do not let moisture from your hand come in contact with the bandage. The moisture could cause the bandage to become sticky.
Precautions • Once applied, do not attempt to reposition the bandage. A new bandage should be applied to other exposed bleeding sites. • Care must be taken to avoid contact with the patient’s eyes. • If bandage sticks, but does not completely stop bleeding. Do not remove bandage right away. Depending on circumstances, it may be best to leave bandage on rather than trying to place a new bandage. • If bandage is not effective in stopping bleeding, remove original and apply a new bandage. Additional bandages cannot be applied over ineffective bandages.
What About Shellfish Allergies? • There have been no known allergic reactions as a result of using the Hem. Con Bandage since distribution began in 2003 and there have been no adverse effects reported in over 750, 000 bandages shipped. • Shellfish allergy study shows that, out of 221 individuals with suspected hypersensitivity, including 8 individuals with known shellfish allergies, none demonstrated any dermal sensitivity when pricked with a chitosan test solution. However, since chitosan is extracted from the shells of shrimp, other shellfish and fungi, individuals with known shellfish allergies should exercise caution in the use of products containing chitosan.
Instructions for Removal • The bandage can be left in place for up to 48 hours. • Do not remove bandage until definitive surgical care is available. • To remove, simply irrigate the area with saline. There is no need for wound debridement.
Hem. Con Bandage In Use Head Injury (OIF) Gun Shot Wound
Hem. Con Bandage In Use Gun Shot Wound (Exit) Facial Abrasions
Thank You For further information please contact: Hem. Con Medical Technologies, Inc. 10575 SW Cascade Ave. Portland, OR 97223 +1. 503. 245. 0459 www. hemcon. com