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Indocyanine Green

Phase 1

Lower Extremity Lymphedema | Small molecule | Other |Tactile Systems Technology, Inc.|Last Updated: May 29, 2026

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07613931Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema TreatmentEARLY_PHASE1 NOT YET_RECRUITING 5Apr 1, 2026Sep 1, 2026May 29, 2026 -
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Study Endpoints
Primary Endpoints
Lymphatic anatomy
Before and after 60-minute treatment in clinic with APCD

• The distance (cm) that lymph travels from injection sites

Lymphatic propulsion
Before and after 60-minute treatment in clinic with APCD

• Number of lymph propulsion events per minute

Secondary Endpoints
Evaluate swelling in treatment limbs
Before and after 60-minute treatment in clinic with APCD
Adverse Events
Through completion of study at Visit 2, up to 4 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDEVICE_FEASIBILITY
Treatment Arms
ArmTypeDescription
Treatment groupEXPERIMENTAL -
Interventions
NameTypeDescription
Advanced pneumatic compression device (APCD)DEVICESingle APCD treatment session at visit 1
Advanced pneumatic compression device (APCD) with revised compression programmingDEVICEAPCD with revised compression programming will be single treatment session at visit 2
Indocyanine Green (IC-Green)DRUGIndocyanine Green dye will be used to assess primary endpoint
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. 18 years of age or older 2. A diagnosis of active lower extremity lymphedema, as assessed by medical history 3. Participant is a candidate for APCD treatment per the Flexitouch Plus indications for use 4. Must be able to provide informed consent prior to study participation 5...

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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07613931NEW_TRIAL: changed
LOWMay 29, 2026NCT07613931NEW_TRIAL: changed
LOWMay 29, 2026NCT07613931NEW_TRIAL: changed