Where was the Resurge Therapeutics First-in-Human (FIH) study run?

The Resurge Therapeutics First-in-Human (FIH) study was executed in Dominican Republic by bioaccess® in the urology / men's health area.

What was the outcome of the Resurge Therapeutics study?

Reported outcomes for Resurge Therapeutics's device: FIH study completed in the Dominican Republic with urology-specialized investigational site; 6-month safety and performance results presented at the AUA Annual Meeting; Publication-quality, conference-ready FIH data generated in Latin America.

Resurge Therapeutics — First-in-Human Urology Device Study Delivers AUA-Presented 6-Month Results in the Dominican Republic

Name: Resurge Therapeutics — First-in-Human Urology Device Study Delivers AUA-Presented 6-Month Results in the Dominican Republic
Creator: bioaccess®

Resurge Therapeutics developed the IPDE™ device — a minimally invasive intraprostatic drug elution system targeting the root cause of BPH/LUTS. bioaccess® managed the complete FIH program in the Dominican Republic, generating 6-month clinical data presented at the AUA Annual Meeting.

Study facts

Sponsor / company: Resurge Therapeutics
Indication / area: Urology / Men's Health
Country: Dominican Republic
Study type: First-in-Human (FIH)

Key metrics

FIH Study: Completed
Country: Dom. Republic
Results: AUA Presented
Next Phase: 30–40 pts

The challenge

Resurge Therapeutics developed the IPDE™ device — a minimally invasive intraprostatic drug elution system targeting the root cause of BPH/LUTS with a localized, sustained-release drug delivery approach. The company needed a FIH study conducted outside the US that could generate the safety and performance data required for their FDA regulatory pathway, with access to a urology-specialized clinical site, fast regulatory approval, experienced investigators, and a cost structure appropriate for a capital-efficient startup timeline.

bioaccess® solution

Resurge Therapeutics selected bioaccess® to build and execute their FIH program in the Dominican Republic — a strategic choice for its efficient ethics committee approval pathway and access to high-volume urology programs. bioaccess® managed the complete regulatory and clinical operations workflow from site identification through study execution, including site search and selection, full regulatory and ethics committee submissions, study startup and site activation, ongoing CRA monitoring and data quality oversight, and Phase 2 expansion planning for 30–40 additional OUS subjects.

Results

FIH study completed in the Dominican Republic with urology-specialized investigational site
6-month safety and performance results presented at the AUA Annual Meeting
Publication-quality, conference-ready FIH data generated in Latin America
Full regulatory and ethics committee approvals secured in Dominican Republic
Ongoing CRA monitoring and data quality oversight maintained throughout study
Phase 2 expansion to 30–40 additional OUS subjects in planning for H2 2026

Frequently asked

What did bioaccess® do for Resurge Therapeutics?: Resurge Therapeutics selected bioaccess® to build and execute their FIH program in the Dominican Republic — a strategic choice for its efficient ethics committee approval pathway and access to high-volume urology programs.
Where was the Resurge Therapeutics First-in-Human (FIH) study run?: The Resurge Therapeutics First-in-Human (FIH) study was executed in Dominican Republic by bioaccess® in the urology / men's health area.
What was the outcome of the Resurge Therapeutics study?: Reported outcomes for Resurge Therapeutics's device: FIH study completed in the Dominican Republic with urology-specialized investigational site; 6-month safety and performance results presented at the AUA Annual Meeting; Publication-quality, conference-ready FIH data generated in Latin America.

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