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Nexusuro
Technical White Paper

Nexusuro Prostate Dilation System.

Transurethral mechanical dilation for BPH — no thermal energy, no implant, no drug coating. This paper summarizes the mechanism, design, clinical evidence, and regulatory status.

Nexusuro Prostate Dilation System technical white paper

Product overview

The Nexusuro Prostate Dilation System is a transurethral mechanical dilation device for BPH. Its core mechanism is controlled expansion of the prostatic urethra via balloon catheter — relieving obstruction caused by prostate enlargement.

Unlike MIST approaches relying on laser, RF, or steam, this system is purely mechanical. That yields structural advantages: no thermal injury, no permanent implant, local anesthesia in most patients, and modest equipment requirements suitable for hospitals at various infrastructure levels.

Mechanism of action

  1. 1. Insertion — catheter guided through the urethra to the prostatic segment.
  2. 2. Positioning — Positioning Balloon anchors at the bladder neck; Anchoring Balloon provides stable fixation.
  3. 3. Dilation — Working Balloon inflated to 3-4 ATM, maintained ~5 minutes, creating uniform columnar expansion.
  4. 4. Removal — balloons sequentially deflated, catheter withdrawn. No device remains in the body.

Indications & patient selection

  • - Moderate to severe LUTS with inadequate medication response or intolerance
  • - Patients seeking to avoid traditional TURP or permanent implants
  • - Candidates assessed as suitable by the treating urologist

Actual clinical application is subject to product Instructions for Use, approved indications, and physician assessment.

Product design

Control platform

Simple interface for urology teams at varied experience levels. Pressure and time configurable per case. Standard hospital disinfection protocols apply.

Single-use balloon catheter

Disposable, sterile-packaged. Stored at room temperature in dry conditions. Eliminates cross-infection risk.

TUCBDP procedure — clinical setting with endoscopy tower and urology team

Clinical evidence

Controlled studies vs. TURP

Mechanical dilation systems show comparable short-to-medium-term IPSS/QOL improvement to TURP in appropriately selected patients, with more favorable complication and recovery profiles. Long-term durability data is still maturing.

Safety profile

Low serious complication rate. Primary adverse events: transient hematuria, urinary irritation, short-term voiding symptoms. No thermal-injury complications. High patient satisfaction with procedural experience and recovery.

Full clinical data

Compliance & manufacturing

  • NMPA Registered in China
  • ISO 13485 Quality system certified (manufacturing partner)
  • GMP Compliant facility in Hangzhou, China
  • CE / FDA In progress — status subject to official disclosure

Applicable settings

  • - General hospital urology departments
  • - Day surgery centers and specialty clinics
  • - Hospitals with endoscopic capabilities
  • - Hospitals adding MIST to existing BPH programs

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This white paper summary is for informational purposes and does not constitute medical advice. Product specifications and regulatory status vary by market.