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Arista

Phase 1

Blood Loss, Surgical | Small molecule | Other |Becton, Dickinson and Company|Last Updated: Sep 19, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05522153Arista Hemostatic Powder for Total Knee Post Operative Outcomes StudyPHASE1 COMPLETED 61May 1, 2021Jun 8, 2023Sep 19, 20241 United States
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Study Endpoints
Primary Endpoints
Blood Loss
Time of incision until 90 days post-op

Calculated on standard hospital protocol

Secondary Endpoints
Thigh Circumference
3 months post op
Range of Motion
3 months post op
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arista groupEXPERIMENTALthis group of randomized patients will receive 5 grams of arista hemostatic powder intra-operatively in their wound in addition to 1 gram of IV transexemic acid prior to incision
control groupNO_INTERVENTIONthis group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision
Interventions
NameTypeDescription
AristaDRUGhemostatic powder
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * • They willingly desire to participate and signed the informed consent * Are between the ages of 18 and 100 years of age * Have the mental capacity to provide consent * Are undergoing a primary unilateral total knee arthroplasty Exclusion Criteria: * • allergy to Aris...

Countries:United States
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