Wortham Laboratories. Introduction Bleeding Issues Overview Bleeding is still a major cause of...

Wortham LaboratoriesWortham Laboratories

FastActFastActFastActFastAct®® Presentation Presentation

IN-PROCESS COPYIN-PROCESS COPYPresentation NOT FOR RELEASE! – 10.2007Presentation NOT FOR RELEASE! – 10.2007

©©2007 Wortham Laboratories, Inc.2007 Wortham Laboratories, Inc.

Wortham TrainingWortham TrainingThis presentation is intended to inform our sales network and professional medical This presentation is intended to inform our sales network and professional medical practitioners about the next generation of coagulation products. This presentation is made practitioners about the next generation of coagulation products. This presentation is made available with the following available with the following important conditionsimportant conditions inherent to the delivery of product inherent to the delivery of product information to the medical community and our sales network:information to the medical community and our sales network:

While the information prepared herein is presented in good faith, changes may occur which While the information prepared herein is presented in good faith, changes may occur which affect the intended result of this presentation. Please understand that literature and training affect the intended result of this presentation. Please understand that literature and training regarding the proper utilization of Wortham products may be updated at any time. Material regarding the proper utilization of Wortham products may be updated at any time. Material changes in product information will be made available as changes are made.changes in product information will be made available as changes are made.

This presentation was prepared in October 2007. Each WLI Presentation is presented with This presentation was prepared in October 2007. Each WLI Presentation is presented with version date.version date.

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This presentation contains internationally recognized trademark of Wortham Laboratories, This presentation contains internationally recognized trademark of Wortham Laboratories, Incorporated.Incorporated.Other trademarks referenced herein are the property of their specific owners, and are Other trademarks referenced herein are the property of their specific owners, and are incorporated throughout for the exclusive purpose of information, education and training.incorporated throughout for the exclusive purpose of information, education and training.

THIS PRESENTATION IS FORMATTED FOR NARRATIVE HOSTING, and cannot serve as a sole THIS PRESENTATION IS FORMATTED FOR NARRATIVE HOSTING, and cannot serve as a sole product insert or instructional reference document.product insert or instructional reference document.

WELCOME TO WORTHAM LABORATORIES – TOMORROW’S TECHNOLOGY TODAYWELCOME TO WORTHAM LABORATORIES – TOMORROW’S TECHNOLOGY TODAY

IntroductioIntroductionn

Bleeding Issues OverviewBleeding Issues OverviewBleeding is still a major cause of morbidity and mortality in wounds. Thirteen percent (13%) of patients suffering acute trauma die of bleeding. In trauma survivors, inability to control bleeding leads to blood transfusion, increased complication rates, immunosuppression, inability to generate red blood cells and prolonged time in the hospital.

Bleeding from elective surgeries, though not statistically as high as acute trauma, nevertheless does impact the patient by the amount of blood loss and the ability to control bleeding.

This can be seen by blood requirements and loss in a few urological procedures:ProcedureProcedure Blood RequirementBlood Requirement Avg. Blood LossAvg. Blood Loss

TURPTURP 2 units x match2 units x match 400 – 500 ml400 – 500 ml

Open ProstatectomyOpen Prostatectomy 2 units x match2 units x match 1050 ml1050 ml

CystectomyCystectomy 4 units x match4 units x match 500 – 1200 ml500 – 1200 ml

Nephrectomy with IVC Nephrectomy with IVC dissectiondissection

6 units minimum6 units minimum 1400 – 3200 ml1400 – 3200 ml

Large glandLarge gland InfectionInfection MalignancyMalignancy Open vs. closed procedureOpen vs. closed procedure Duration of surgery:Duration of surgery:

> 60 – 90 minutes = dramatic increase> 60 – 90 minutes = dramatic increase Attention to hemostasisAttention to hemostasis Fibrinolysis, where urokinase activates Fibrinolysis, where urokinase activates

local plasminogenlocal plasminogen

Bleeding is increased by:Bleeding is increased by:

Impact on SurgeonImpact on Surgeon

Bleeding intrinsically impacts the surgeon, too, by a state of stress and anxiety that begins prior to surgery and lasts at least through the first 24-48 hours post-op.

The ideal solution to this problems is to control the bleeding in the first place.

A quick, effective and safe device to control bleeding is found in a new hemostatic agent, FastAct®.

Characteristics of Characteristics of FastActFastAct®

FastAct® is a one component primary hemostatic agent, designed to arrest most hemorrhages in 1-3 seconds – and large arterial bleeds within 10 seconds.

FastAct® is also effective in patients on anticoagulant therapy or patients with coagulopathy.

The active proteins in FastAct® are bovine proteins: Factor II, VII, IX and X. These proteins are isolated from BSE-free plasma.

The stabilizers in FastAct® allow the product to go through repetitive freeze-thaw cycles without losing activity.

Contrast:Contrast:FastActFastAct®®

vs.vs.Standard Surgical Standard Surgical

MethodsMethods-and--and-

Other Hemostatic Other Hemostatic AgentsAgents

PrimaryPrimary hemostatic agent hemostatic agent Achieves hemostasis in Achieves hemostasis in secondsseconds vs. minutes vs. minutes

Effective in the presence of Effective in the presence of anticoagulant drugs and anticoagulant drugs and coagulopathycoagulopathy

Blood transfusions reduced by Blood transfusions reduced by 90%90%

Advantages of FastActAdvantages of FastAct®®::

Surgical time reduced by Surgical time reduced by 50%50%

No loss of tissueNo loss of tissue Shorter healing timeShorter healing time No mixing, no preparationNo mixing, no preparation Multiple delivery systems vs. Multiple delivery systems vs.

one systemone system Reduces overall costsReduces overall costs

Advantages of FastActAdvantages of FastAct®®::

Cost Saving Examples:Cost Saving Examples:

Assume the following:

Operating TheaterOperating Theater $10 / minute$10 / minute

AnethesiaAnethesia $5 / minute$5 / minute

BloodBlood $100 / unit$100 / unit

Pain medicationPain medication $2 / pill$2 / pill

Hospital roomHospital room $50 / day$50 / day

Example I - Mastectomy:Example I - Mastectomy:

STANDARDSTANDARD SAVINGSSAVINGSOROR 60 minutes60 minutes 15 minutes15 minutes $150.00$150.00

AnesthesiaAnesthesia 60 minutes60 minutes 15 minutes15 minutes $75.00$75.00

UnitsUnits 00 0 Units0 Units 00

MedicationMedication 15 pills15 pills 3 pills3 pills $6.00$6.00

Hospital RoomHospital Room 4 days4 days 1 day1 day $50.00$50.00

Sub TotalSub Total $281.00$281.00

FastAct CostFastAct Cost $50 [ 1 ml ]$50 [ 1 ml ]

Total SavingsTotal Savings $231.00$231.00

Numbers presented are quite conservative. Nevertheless, they represent substantial savings to the patient, hospital or government for each surgical case.

Example II – Example II – Hip Replacement:Hip Replacement:



UnitsUnits 2-32-3 1 Unit1 Unit $100.00$100.00







Example III – Example III – Femoral-Popetial Bypass:Femoral-Popetial Bypass:



UnitsUnits 2-32-3 2 units2 units $200.00$200.00







How FastActHow FastAct®® WorksWorks

Efficacy and SafetyEfficacy and Safety

A. EfficacyA. EfficacySUMMARYSUMMARY

Surgical Site:Surgical Site: Animal Medical CenterAnimal Medical Center

1673 Battlefield Parkway1673 Battlefield Parkway

Fort Oglethorpe, GA USAFort Oglethorpe, GA USA

Veterinarian:Veterinarian: Dr. Candace HaddenDr. Candace Hadden

Animal Model:Animal Model: Oryctolagus cuniculusOryctolagus cuniculus

New Zealand White RabbitNew Zealand White Rabbit

Source:Source: Myrtle’s RabbitryMyrtle’s Rabbitry

4678 Bethesda Road4678 Bethesda Road

Thompsons Station, TN USAThompsons Station, TN USA

Number of Animals:Number of Animals: 3030

Sex:Sex: FastAct Group: Male 9 Female 6FastAct Group: Male 9 Female 6

Control Group: Male 8 Female 7Control Group: Male 8 Female 7

Age:Age: Young Adult (3 months)Young Adult (3 months)

Body Weight:Body Weight: range: 2.7 – 3.5 Kg mean: 2.977 Kgrange: 2.7 – 3.5 Kg mean: 2.977 Kg

Surgical Procedure:Surgical Procedure: Hepatic resection with half of right lobe Hepatic resection with half of right lobe removedremoved

A. Efficacy Continued (2)A. Efficacy Continued (2)SUMMARYSUMMARY

Hemostasis Hemostasis Method:Method:

Investigational Group:Investigational Group: FastAct ONLY used FastAct ONLY used throughout the entire surgery to control bleeding.throughout the entire surgery to control bleeding.

Control Group:Control Group: Standard surgical technique Standard surgical technique (cauterization, direct pressure, ligature) used to control (cauterization, direct pressure, ligature) used to control bleeding.bleeding.

Time to Time to Hemostasis:Hemostasis:

FastActFastAct ControlControl

Range:Range:

Mean:Mean:1-3 1-3

minutesminutes

1.43 min.1.43 min.

Range:Range:

Mean:Mean:1-7 1-7

minutesminutes

4.73 min.4.73 min.

HCT:HCT:

Pre-OpPre-Op

FastActFastAct ControlControl

Range:Range: 35-50%35-50% Range:Range: 38-60%38-60%

Mean:Mean: 45%45% Mean:Mean: 43.93%43.93%

Post-OpPost-OpRange:Range: 35-47%35-47% Range:Range: 30-53%30-53%

Mean:Mean: 39.73%39.73% Mean:Mean: 40.87%40.87%

A. Efficacy Continued (3)A. Efficacy Continued (3)SUMMARYSUMMARY

Blood Loss (ml):Blood Loss (ml): FastActFastAct ControlControl

Range:Range:

Mean:Mean:0.16-4.230.16-4.23

1.571.57Range:Range:

Mean:Mean:0.61-7.660.61-7.66

2.082.08

Surgical Time Surgical Time (minutes):(minutes):

Range:Range:

Mean:Mean:8-11 8-11

6.366.36Range:Range:

Mean:Mean:10-20 10-20

12.6712.67

Complete Complete

Recovery Time:Recovery Time:1 day1 day 5-7 days5-7 days

NECROPSY:NECROPSY:

Fibrous adhesionsFibrous adhesions Less severeLess severe Increased severityIncreased severity

GranulomasGranulomas NoNo YesYes

HISTOPATHOLOGY:HISTOPATHOLOGY:

Chronic InflammationChronic Inflammation None to minimal/mildNone to minimal/mild Minimal to severeMinimal to severe

Related Dose EffectRelated Dose Effect NoNo

B. SafetyB. SafetyTOXICITYTOXICITY

PyrogenicityPyrogenicity Lot 300601Lot 300601

<0.03 EU/ml<0.03 EU/mlLot 302001Lot 302001

<0.03 EU/ml<0.03 EU/mlLot 302701Lot 302701

<0.03 EU/ml<0.03 EU/ml

Lot 321201Lot 321201

<0.03 EU/ml<0.03 EU/mlLot 323801Lot 323801

<0.03 EU/ml<0.03 EU/mlLot 325401Lot 325401

<0.03 EU/ml<0.03 EU/ml

BetadineBetadine Toxicity LevelsToxicity Levels

400 mg/Kg400 mg/KgFastActFastAct

0.1 mg/ml =<0.03 mg/Kg0.1 mg/ml =<0.03 mg/KgNewborn InfantNewborn Infant

Free IodineFree Iodine

ToxicityToxicity

>9.0 ug/dl>9.0 ug/dlLot 119001Lot 119001

<0.1 ug/dl<0.1 ug/dlLot 119002Lot 119002

<0.1 ug/dl<0.1 ug/dlLot 119003Lot 119003

<0.1 ug/dl<0.1 ug/dl

Lot 321201Lot 321201

<0.1 ug/dl<0.1 ug/dlLot 323801Lot 323801

<0.1 ug/dl<0.1 ug/dlLot 321401Lot 321401

<0.1 ug/dl<0.1 ug/dl

B. Safety Continued (2)B. Safety Continued (2)TOXICITYTOXICITY

MorphologyMorphology

UndilutedUndilutedMorphologyMorphology

1:1 Dilution1:1 Dilution

GrowingGrowing RestingResting GrowingGrowing RestingResting

Crandal Feline Crandal Feline Kidney CellsKidney Cells No changeNo change No changeNo change No changeNo change No changeNo change

Rabbit Kidney Rabbit Kidney CellsCells No changeNo change No changeNo change No changeNo change No changeNo change

Madin Dorby Madin Dorby Bovine Kidney Bovine Kidney CellsCells

No changeNo change No changeNo change No changeNo change No changeNo change

Madin Barby Madin Barby Canine Kidney Canine Kidney CellsCells

No changeNo change No changeNo change No changeNo change No changeNo change

ImmunogenicityImmunogenicityDerma SensitivityDerma Sensitivity

Species/Strain:Species/Strain:

Source:Source:

Number of Number of Animals:Animals:

Sex:Sex:

Body Weight:Body Weight:

Study Duration:Study Duration:

Dosage:Dosage:

Route:Route:

Application:Application:Patch Test Patch Test Reaction:Reaction:

Guinea Pig/HartleyGuinea Pig/Hartley

Charles River LaboratoriesCharles River Laboratories

Route 209Route 209

Kingston, NY 12484 USAKingston, NY 12484 USA

1717

FemaleFemale

300-400g300-400g

34 days34 days

FastAct vial: 1ml (3000IU)FastAct vial: 1ml (3000IU)

Foam: 1ml (8000IU)Foam: 1ml (8000IU)

Control: 1ml waterControl: 1ml water

Right flankRight flank

FastAct: FastAct: 99 Control: Control: 99

No visible changeNo visible change

Factor V AntibodiesFactor V Antibodies

Specie/Strain:Specie/Strain:

Source:Source:


Sex:Sex:



Dosage:Dosage:

Booster:Booster:

Route:Route:

Factor V Factor V Antibodies:Antibodies:

Rabbit/New ZealandRabbit/New Zealand

Myrtle’s RabbitryMyrtle’s Rabbitry

4678 Bethesda Road4678 Bethesda Road

Thompsons Station, Tennessee USAThompsons Station, Tennessee USA

1717

Male: 11 Female: 6Male: 11 Female: 6

2.7 – 5.5 Kg2.7 – 5.5 Kg

40 days40 days

Five Animals: 5x dosage (15,000 IU)Five Animals: 5x dosage (15,000 IU)



Positive control: 1ml bovine plasmaPositive control: 1ml bovine plasma

Negative control: No treatmentNegative control: No treatment

14 days post surgery14 days post surgery

Intra-peritoneal (IP)Intra-peritoneal (IP)

No VabNo Vab

Immunogenicity (2)Immunogenicity (2)

Factor V AntibodiesFactor V Antibodies

Specie/Strain:Specie/Strain:

Source:Source:


Sex:Sex:



Dosage:Dosage:

Booster:Booster:

Route:Route:

Factor V Factor V Antibodies:Antibodies:

Rat/LewisRat/Lewis

TaconicTaconic

273 Hover Avenue273 Hover Avenue

Germantown, NY 12526 USAGermantown, NY 12526 USA

1717

Male: 9 Female: 8Male: 9 Female: 8

400 g400 g

40 days40 days




Positive control: 1ml bovine plasmaPositive control: 1ml bovine plasma

Negative control: No treatmentNegative control: No treatment

14 days post initial inoculation14 days post initial inoculation

28 days post initial inoculation28 days post initial inoculation

Intra-peritoneal (IP)Intra-peritoneal (IP)

No VabNo Vab

Immunogenicity (3)Immunogenicity (3)

FastActFastAct®® Clinical Line Clinical Line

TestingTesting

Phase I Clinical TrialPhase I Clinical Trial

Phase I Clinical Trial Phase I Clinical Trial Surgical Surgical Locations:Locations:

Joaquin Albarran Hospital, Havana, CubaJoaquin Albarran Hospital, Havana, Cuba

Salvador Allende Hospital, Havana, CubaSalvador Allende Hospital, Havana, Cuba

National Institute for Cardiovascular Surgery, Havana, CubaNational Institute for Cardiovascular Surgery, Havana, Cuba

Center for Medical-Operative Investigations, Havana, CubaCenter for Medical-Operative Investigations, Havana, Cuba

Objective:Objective: FastAct used as a primary hemostatic agent to control all FastAct used as a primary hemostatic agent to control all bleeding (skin-skin). Two surgical groups utilized only one bleeding (skin-skin). Two surgical groups utilized only one delivery system (vial or spray).delivery system (vial or spray).

Criteria:Criteria: Inclusive:Inclusive: Patients over the age of 18Patients over the age of 18

Patients of both sexesPatients of both sexes

Patients receiving anticoagulant therapyPatients receiving anticoagulant therapy

Patients with a history of blood disordersPatients with a history of blood disorders

Exclusive:Exclusive: Patients who are pregnantPatients who are pregnant

Patients suffering from mental diseasePatients suffering from mental disease

Patients with the HIV virusPatients with the HIV virus

Patients with a history of anaphylaxisPatients with a history of anaphylaxis

Patients receiving beta-blocker treatmentPatients receiving beta-blocker treatment

Patients with bovine protein sensitivityPatients with bovine protein sensitivity

Patients with signs of infectionPatients with signs of infection

Patients who show signs of sepsis during Patients who show signs of sepsis during surgerysurgery

Patients with sensitivity to iodinePatients with sensitivity to iodine

Number of Number of Patients:Patients:

Vial: 36 Spray: 84Vial: 36 Spray: 84

Phase I Clinical Trial: Phase I Clinical Trial: DemographicsDemographics

VIALVIAL SPRAYSPRAY

AGAGEE

MaleMale FemaleFemale TotalTotal MaleMale FemaleFemale TotalTotal

## %% ## %% ## %% ## %% ## %% ## %%18-18-2525

00 0.00.0 11 4.84.8 11 2.72.7 99 26.026.0 22 4.14.1 1111 13.013.0

26-26-3535

11 6.66.6 11 4.84.8 22 5.55.5 66 17.117.1 66 12.212.2 1212 14.214.2

36-36-4545

44 26.726.7 88 38.138.1 1212 33.333.3 55 14.214.2 1313 26.526.5 1818 21.421.4

46-46-5555

22 13.313.3 44 19.019.0 66 16.516.5 88 23.023.0 77 14.314.3 1515 17.817.8

56-56-6565

44 26.726.7 44 19.019.0 88 22.222.2 22 5.75.7 1414 28.528.5 1616 19.019.0

66-66-7575

44 26.726.7 22 9.59.5 66 16.516.5 44 11.411.4 55 10.210.2 99 11.011.0

76-76-8585

00 0.00.0 11 4.84.8 11 2.72.7 00 0.00.0 00 0.00.0 00 0.00.0

8686 00 0.00.0 00 0.00.0 00 0.00.0 11 2.82.8 22 4.14.1 33 3.63.6

TotalTotal 1515 100100 2121 100100 3636 100100 3535 100100 4949 100100 8484 100100

Phase I Clinical Trial: Phase I Clinical Trial: HematologicalHematological

VIALVIAL SPRAYSPRAY

MinMin MaxMax AvgAvg MinMin MaxMax AvgAvg

HGB:HGB: MaleMale Pre-OpPre-Op 8.68.6 15.815.8 12.912.9 9.19.1 17.617.6 13.313.3

Post-Post-OpOp

8.88.8 13.113.1 11.511.5 15.015.0 16.416.4 15.915.9

FemalFemalee

Pre-OpPre-Op 9.89.8 14.314.3 12.512.5 10.010.0 15.115.1 12.212.2

Post-Post-OpOp

10.610.6 15.115.1 12.612.6 7.97.9 14.514.5 11.611.6

HCT:HCT: MaleMale Pre-OpPre-Op 2525 4545 3838 3030 5454 4242

Post-Post-OpOp

2626 3939 3434 3131 4949 3838

FemalFemalee

Pre-OpPre-Op 2929 4141 3737 3333 4747 3939

Post-Post-OpOp

3131 4646 3636 2424 4343 3636

PT:PT: MaleMale Pre-OpPre-Op 11.411.4 13.013.0 11.911.9 12.212.2 15.215.2 13.413.4

Post-Post-OpOp

11.211.2 14.114.1 12.112.1 12.712.7 14.514.5 13.713.7

FemalFemalee

Pre-OpPre-Op 11.311.3 12.812.8 12.012.0 11.811.8 18.818.8 13.813.8

Post-Post-OpOp

11.611.6 16.216.2 12.712.7 12.112.1 15.015.0 13.413.4

APTT:APTT: MaleMale Pre-OpPre-Op 23.923.9 38.938.9 28.728.7 23.023.0 34.734.7 30.130.1

Post-Post-OpOp

25.025.0 40.040.0 30.930.9 26.426.4 48.048.0 34.834.8

FemalFemalee

Pre-OpPre-Op 23.023.0 32.032.0 26.326.3 23.723.7 40.040.0 30.730.7

Post-Post-OpOp

23.223.2 30.430.4 26.226.2 24.024.0 42.042.0 30.830.8

Phase I Clinical TrialPhase I Clinical TrialSURGICAL OVERVIEWSURGICAL OVERVIEW

Number (#)Number (#) Percentage (%)Percentage (%)

GynecologyGynecology 44 3.333.33

GastrointestinalGastrointestinal 3333 27.527.5

VascularVascular 1616 13.3313.33

OrthopedicOrthopedic 1212 10.010.0

ENTENT 2424 2.02.0

UrologyUrology 1212 10.010.0

General SurgeryGeneral Surgery 1919 15.8315.83

TotalTotal 120120 100.00100.00

Phase I Clinical TrialPhase I Clinical Trial

--Organ----Organ--

TARGETED ORGANTARGETED ORGAN


BreastBreast 66 5.05.0


BoneBone 1212 10.010.0

BowelBowel 55 4.24.2

AnusAnus 2828 23.423.4

ProstateProstate 1010 8.38.3

ParotidParotid 11 0.80.8

ThyroidThyroid 44 3.33.3

KidneyKidney 11 0.80.8

TonsilTonsil 1919 15.915.9

Skin-MuscleSkin-Muscle 1313 10.810.8

UterusUterus 44 3.33.3

BladderBladder 11 0.80.8

Phase I Clinical Study Phase I Clinical Study

Time to HemostasisTime to Hemostasis

VIALVIAL SPRAYSPRAY

MinutesMinutes Number Number

(#)(#)Percentage Percentage

(%)(%)Number Number

(#)(#)Percentage Percentage

(%)(%)

0-50-5 3636 100.00100.00 8181 96.496.4

6-106-10 00 0.000.00 3*3* 3.63.6

TotalTotal 3636 100.00100.00 8484 100.00100.00

0-5 Minutes0-5 Minutes MinMin MaxMax AvgAvg

0.020.02 4.004.00 1.301.30

* Medium size arterial bleed – not allowed to use vial delivery system* Medium size arterial bleed – not allowed to use vial delivery system

FastActFastAct®® Dosage Dosage

Range:Range: 1,500-15,000 IU1,500-15,000 IU

Mean:Mean: 3,800 IU3,800 IU

SAFETYSAFETY Number (#)Number (#)

30 DAY 30 DAY

POST-OPPOST-OPEXAMINATIONEXAMINATION

NO NO COMPLICATIONCOMPLICATION

SS

Post-Operative BleedingPost-Operative Bleeding 00

AnemiaAnemia 00

Arterial FibrillationArterial Fibrillation 00

InfectionInfection 00

HemorrhageHemorrhage 00

PneumoniaPneumonia 00

Urinary Tract InfectionUrinary Tract Infection 00

RashRash 00

EdemaEdema 00

HypotensionHypotension 00

Respiratory DistressRespiratory Distress 00

ConfusionConfusion 00

Dura TearDura Tear 00

Ventricular FibrillationVentricular Fibrillation 00

ArrhythmiaArrhythmia 00

Heart FailureHeart Failure 00

Arterial ThrombosisArterial Thrombosis 00

FeverFever 00

AtelectosisAtelectosis 00

Pleural EffusionPleural Effusion 00

FastActFastAct®® Clinical Line Clinical Line

TestingTesting

Phase II Clinical TrialPhase II Clinical Trial

Phase II Clinical Trial Phase II Clinical Trial Surgical Surgical Locations:Locations:

Hospital Edgardo Rebagliati Martins, Lima, PeruHospital Edgardo Rebagliati Martins, Lima, Peru

Hospital Nacional Guillermo Almentara 1. Es Salud, Lima, PeruHospital Nacional Guillermo Almentara 1. Es Salud, Lima, Peru

Objective:Objective: Investigational group: FastAct used as sole means to control Investigational group: FastAct used as sole means to control all bleeding at the targeted organ.all bleeding at the targeted organ.

Criteria:Criteria: Inclusive:Inclusive: All ages and both gendersAll ages and both genders

Wounds of a similar size, type, location and bleeding Wounds of a similar size, type, location and bleeding tendency.tendency.

On anticoagulation therapy, with no dosage On anticoagulation therapy, with no dosage limitations.limitations.

Diagnosed with a coagulation disorder.Diagnosed with a coagulation disorder.

Participants must be able to participate for the 30 day Participants must be able to participate for the 30 day duration of the study.duration of the study.

ExclusiveExclusive::

Any clinically infected wound, draining pus, Any clinically infected wound, draining pus, surrounding erythema or edema, or patients with surrounding erythema or edema, or patients with systemic signs of infections.systemic signs of infections.

Subjects on antibiotic therapy prior to enrollment.Subjects on antibiotic therapy prior to enrollment.

Subjects with known allergy to bovine proteins, atopic Subjects with known allergy to bovine proteins, atopic reactions, history of anaphylaxis.reactions, history of anaphylaxis.

Inability to give informed consent.Inability to give informed consent.

Inability to return for a 30 day follow-up visit.Inability to return for a 30 day follow-up visit.

Number of Number of Patients:Patients:

127127

Phase II Clinical Trial: Phase II Clinical Trial: DemographicsDemographics

Adults (115)Adults (115) Pediatric (12)Pediatric (12)

MaleMale FemaleFemale MaleMale FemaleFemale

## %% ## %% ## %% ## %%5656 48.748.7 5959 51.351.3 66 5050 66 5050

AgeAge

(years(years))

20-91 years20-91 years 18-92 years18-92 years 20 days to 11 20 days to 11 yearsyears

7 months-16 7 months-16 yearsyears

Mean:Mean: 53.853.8 56.856.8 ---- ----

WeighWeightt

(Kg)(Kg)

50-92 Kg50-92 Kg 50-78 Kg50-78 Kg 1.8-45 Kg1.8-45 Kg 7-50 Kg7-50 Kg

Mean:Mean: 68.8 Kg68.8 Kg 66.1 Kg66.1 Kg 21.8 Kg21.8 Kg 22.2 Kg22.2 Kg


HEPARIN DOSAGEHEPARIN DOSAGE

MALEMALE FEMALEFEMALE

Number (#)Number (#) 3030 2020

Percentage (%)Percentage (%) 24.224.2 16.116.1

DosageDosage 300 – 5,000 U/Kg300 – 5,000 U/Kg 300- 5,000 U/Kg300- 5,000 U/Kg

MeanMean 960 U/Kg960 U/Kg 1,720 U/Kg1,720 U/Kg


SURGICAL OVERVIEWSURGICAL OVERVIEWNumber (#)Number (#) Percentage (%)Percentage (%)

HeartHeart 3030 23.623.6


NeurosurgeryNeurosurgery 1111 8.78.7

Head & NeckHead & Neck 1515 11.811.8

OrthopedicsOrthopedics 77 5.55.5

LiverLiver 1515 11.811.8

SpleenSpleen 55 3.93.9

GastrointestinalGastrointestinal 3434 26.826.8

GynecologicalGynecological 22 1.61.6

MiscellaneousMiscellaneous 22 1.61.6

TOTALTOTAL 127127 100%100%


Surgical Rating of Expected Surgical Rating of Expected

Severity of Blood LossSeverity of Blood Loss


None (0 ml)None (0 ml) 00 0.00.0

Little (1-25 ml)Little (1-25 ml) 00 0.00.0

Moderate (25-200 ml)Moderate (25-200 ml) 1111 8.78.7

Heavy (200-250 ml)Heavy (200-250 ml) 6262 48.848.8

Severe >500 mlSevere >500 ml 5454 42.542.5

TotalTotal 127127 100100

Phase II Clinical TrialPhase II Clinical TrialFastActFastAct®® Dosage Dosage

MaleMale FemaleFemale

Range:Range: 900 – 1,200 IU900 – 1,200 IU 300 – 1,500 IU300 – 1,500 IU

MeanMean 450 IU450 IU 501 IU501 IU

Time to HemostasisTime to HemostasisFastActFastAct®® ControlControl

Range:Range: 0.5 – 10 Min0.5 – 10 Min 2 – 90 Min2 – 90 Min

Mean:Mean: 1.62 Min1.62 Min 30.79 Min30.79 Min

Blood LossBlood LossRange:Range: 5 – 2,000 ml5 – 2,000 ml 50 – 3,000 ml50 – 3,000 ml

Mean:Mean: 206.57 ml206.57 ml 595.63 ml595.63 ml

Efficacy:Efficacy:

No abandonment of FastAct for another No abandonment of FastAct for another hemostatic product. FastAct achieved the hemostatic product. FastAct achieved the parameters of the protocol by achieving parameters of the protocol by achieving hemostasis 19 times faster than cauterization, and hemostasis 19 times faster than cauterization, and reduced blood loss by 50%.reduced blood loss by 50%.

SAFETY – Phase II Clinical TrialSAFETY – Phase II Clinical Trial Number (#)Number (#)

30 DAY 30 DAY

POST-OPPOST-OPEXAMINATIONEXAMINATION

NO NO COMPLICATIONCOMPLICATION

SS

Post-Operative BleedingPost-Operative Bleeding 00

AnemiaAnemia 00

Arterial FibrillationArterial Fibrillation 00

InfectionInfection 00

HemorrhageHemorrhage 00

PneumoniaPneumonia 00

Urinary Tract InfectionUrinary Tract Infection 00

RashRash 00

EdemaEdema 00

HypotensionHypotension 00

Respiratory DistressRespiratory Distress 00

ConfusionConfusion 00

Dura TearDura Tear 00

Ventricular FibrillationVentricular Fibrillation 00

ArrhythmiaArrhythmia 00

Heart FailureHeart Failure 00

Arterial ThrombosisArterial Thrombosis 00

FeverFever 00

AtelectosisAtelectosis 00

Pleural EffusionPleural Effusion 00

Presentation is Complete.Presentation is Complete.T h a n k Y o uT h a n k Y o u

WorthamWorthamWortham Laboratories, Inc.Wortham Laboratories, Inc.

www.worthamlabs.comwww.worthamlabs.com

©2007 Wortham Laboratories, Inc.©2007 Wortham Laboratories, Inc.All Rights ReservedAll Rights Reserved

International Office: USA 1+423.296.0090International Office: USA 1+423.296.0090

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