Resurge Therapeutics — First-in-Human Urology Device Study in the Dominican Republic — Positive 1-Year IPDE Results Reported at AUA 2026

Resurge Therapeutics developed the IPDE™ (intraprostatic drug elution) device — a minimally invasive platform targeting the root cause of BPH/LUTS. bioaccess® managed the complete first-in-human program in the Dominican Republic. In May 2026, Resurge reported positive 1-year results from two studies of the platform at the AUA 2026 Annual Meeting; the device remains investigational.

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 2026 (1-yr)
• 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
• Positive 1-year results from two studies of the IPDE™ platform reported at AUA 2026 (May 2026): a transperineal cohort (n=20) showed IPSS improvement with benefit reported in approximately 80% of patients, and a transrectal cohort (n=11) — as disclosed by the sponsor; IPDE™ remains investigational
• 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; Positive 1-year results from two studies of the IPDE™ platform reported at AUA 2026 (May 2026): a transperineal cohort (n=20) showed IPSS improvement with benefit reported in approximately 80% of patients, and a transrectal cohort (n=11) — as disclosed by the sponsor; IPDE™ remains investigational.

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