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Critical Care Line “The last line of defense for your patient”™ The information contained in this brief is the intellectual property of Green Dot Systems Inc. and under no circumstances be released without the effective consent of the owner. U.S. copyright and patent laws apply to all products depicted herein. 9/1/2015

CCL Presentation

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Critical Care Line“The last line of defense for your patient”™

The information contained in this brief is the intellectual property of Green Dot Systems Inc. and under no circumstances be released without the

effective consent of the owner. U.S. copyright and patent laws apply to all products depicted herein.

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Agenda

• Intro

• Capability gap discussion

• Supporting guidelines

• Critical Care Line specifications

• Critical Care Line indications for use

• Critical Care Line advantages

• Questions

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Capability Gap

• There are NO products currently on the market that are capable of delivering crystalloids, colloids, blood products and medications in a single administration set

• Y-Tubing have no drug ports

• Only has a single purpose

• Form factor varies by manufacturer

• Boxed, plastic, etc.

• Macro Drip sets do not have filters for blood products

• Blood products save lives, but medics don’t have an optimized tool to routinely deliver this care on their backs

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Supporting Guidelines

• CoTCCC Guidelines• Blood products are first line for hemorrhagic shock• Replacing lost blood with new blood saves lives

• Reduces mortality at the 10-14 day mark

• First line• Fresh Whole Blood (FWB) or Whole Blood (WB)

• Second Line • Packed Red Blood Cells (PRBCs)/Plasma/Platelets• 1:1:1 ratio

• Third line Hextend• FDA Back box warning for use in critically injured patients• Probably the worst choice for fluids in trauma

• Fourth Line• Crystalloids (Normal Saline, Plasmalyte)

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The precedence has been set

• CENTCOM “Vampire Program”

• Army MEDEVAC deliverered PRBCs to over 170 patients in Afghanistan with no adverse reactions

• Ranger Hargis

• First casualty to receive Freeze Dried Plasma (FDP) and survive since WWII

• Prolonged Field Care (PFC)

• This is the newly developed program that must be adopted early to gain market dominance

• Difficult to define

• Beyond TCCC (beyond the first hour of care)

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The evolution of the CCL

• Early beginnings as the “Shock Cord”• Developed by Joe Paisley 18D, USASOC Operator• Innovative method to address capability gap

• Modified fall 2014• Kyle Faudree, Lead Inventor• Reduction of potential failure points• Removal of 3 way stopcock• Addition of drip chambers (drug calc)

• Manufactured by Codan• Class II medical device• FDA 510k cleared• EVO sterilized (with validation from the FDA)• Second party verification of clearance

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The CCL

• 90” overall length• Optimized for use in any TACEVAC platform

• Based on “floor to ceiling” measurements

• Chinook, Blackhawk, Osprey, Sea King, Hercules, etc.

• 2 x 10 gtts (drop) per mL Drip chambers• Easy math (especially for Tranexamic Acid, aka TXA)

• Approx. 1 drop per second

• Addition of drip chambers (drug calculations)

• 170 Micron Filter• Offers the best flow rates while remaining with guidelines

• American Academy of Blood Banking (AABB)

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The CCL

• 2 x Slide Clamps

• Allows the operator to “pinch” the line for an I.V./I.O bolus of medications

• 2 x Needless injection ports

• 18” from solution set spike (ease of access)

• 6” from distal end (ease of access)

• Reduces risk of accidental needlestick

• Vented cap

• Allows for priming of the infusion set without removing cap

• Decreases potential for introduction of contaminants

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The CCL

2 x 10 gtts/ml drip chambers

2 x roller clamps

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The CCL

170 Micron Filter

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The CCL

Pinch Clamp

Pinch Clamp

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The CCL

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CCL Indications

• Blood & Blood Products

• TXA

• Medications (antibiotics, pain control, nausea, etc.)

• Rehydration (crystalloids)

• Head Injury

• Mannitol requires the use of an in-line filter

• 5 micron minimum

• Due to potential crystallization of the sugar molecules

• CBRN

• Autoinjectors are temporizing measures

• Pralidoximine (2-Pam) continuous infusion

• Atropine attenuated to bronchial secretions

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CCL Advantages

• Reduced weight and cube

• One infusion set that can perform ALL tasks

• Reduced cost for additional vascular access

• No longer required to gain two points of access

• Decreased logistical footprint

• Embassies

• Forward operating locations (remote)

• Operations Outside of Declared Theaters of Active Armed Conflict (OODTAC)

• Eliminates risk of mission failure

• The CCL reduces medical operator stress during difficult patient care delivery and increases the level of care provided to America’s sons and daughters in their time of need.

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Questions?

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