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MyoScience Tissue Remodeling Device

Phase 1

Facial Rhytides | Unknown | Other |Pacira BioSciences, Inc.|Last Updated: Mar 24, 2015

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 Enrollment380
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00842062Study of the MyoScience Tissue Remodeling Device for Facial RejuvenationPHASE1 COMPLETED 380Feb 1, 2009Jan 1, 2012Mar 24, 20151 United States
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Study Endpoints
Primary Endpoints
Investigators' and subjects'rating of line severity in the target areas at rest and in animation at each follow-up interval.
Up to 6 months
Secondary Endpoints
Incidence of adverse events
Up to 6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MyoScience Tissue Remodeling DeviceEXPERIMENTAL -
Interventions
NameTypeDescription
MyoScience Tissue Remodeling DeviceDEVICEPercutaneous treatment with the MyoScience device
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Eligibility Criteria
Age Range30 Years — 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The subject must be a female 30 to 70 years of age. * The subject must have a clinical examination prior to treatment including assessment of hyperdynamic line severity. * The subject must have a wrinkle rating of at least "1" at rest in one or more of the following treatment ...

Countries:United States
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