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CM-1500

Phase 1

Blood Loss | Unknown | Other |Zynex, Inc.|Last Updated: Jul 21, 2021

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
RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01834612Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood DrawPHASE1 COMPLETED 20Jan 7, 2013Mar 11, 2013Jul 21, 20211 United States
NCT01646060Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood DrawPHASE1 COMPLETED 10Nov 1, 2011Dec 1, 2011Jul 20, 20121 United States
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Study Endpoints
Primary Endpoints
Detect change in blood volume by non-invasive monitoring during whole blood draw
4 months
Detect change in blood volume during blood draw
15-30 minutes
Secondary Endpoints
Detect insidious bleeding
15-30 minutes
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Blood drawACTIVE_COMPARATORCM1500 with blood draw
No blood drawSHAM_COMPARATORCM 1500 with no blood draw
Interventions
NameTypeDescription
CM1500DEVICEblood volume monitor
CM-1500DEVICEBlood Volume Monitor
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy volunteer * between 18 to 50 years of age * weight between 157 to 220 lbs Exclusion Criteria: * unstable or untreated cardia disease * alcohol consumption in 24 hours prior to screening * tobacco use in 4 hours prior to screening * pregnancy * infection * Hemoglobin ...

Countries:United States
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