Prodeon Medical, Inc.


Medical device company developing a minimally invasive, investigational procedure to treat lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia (BPH). The approach uses a temporary, retrievable nitinol expander implant delivered and removed via flexible cystoscopy to reshape the prostatic urethra (Prostatic Urethral REshaping, PURE). The company conducts multinational clinical studies and disseminates interim and peer-reviewed results.

Industries

N/A

Nr. of Employees

small (1-50)

Prodeon Medical, Inc.


Patents

Self-actuating grasping device

US-12383288-B2

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Devices for the treatment of benign prostatic hyperplasia and related lower urinary tract symptoms

US-11812930-B2

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System and method for increasing a cross-sectional area of a body lumen

US-11547546-B2

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Implantable devices and methods to treat benign prostate hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS)

US-11497637-B2

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Products

Investigational temporary prostatic urethral expander and delivery/retrieval system

A temporary, nitinol-based implant delivered via a flexible cystoscope and designed to expand the prostatic urethra; the system includes a delivery catheter and a retrieval sheath for removal after a dwell time.


Services

Conduct of investigational device clinical trials including site engagement, enrollment, randomized study execution and data collection.

Expertise Areas

  • Minimally invasive urological device development
  • Clinical trial management for implantable devices
  • Prostatic urethral reshaping procedures
  • Preclinical feasibility testing
  • Show More (2)

Key Technologies

  • Nitinol-based implantable devices
  • Flexible cystoscopy-compatible delivery systems
  • Retrieval sheath for removable implants
  • Office-based minimally invasive procedure workflows
  • Show More (2)

News & Updates

Announcement of enrollment completion for the Expander-2 pivotal clinical trial.

Company announcement regarding randomization in the Expander-2 pivotal clinical trial.

Presentation of interim results from the EXPANDER-1 multicenter clinical trial showing feasibility, safety and symptom improvement.

Editorial feature focusing on the investigational expander system and the PURE procedure, including interviews with urology investigators.

Interim results from the EXPANDER-1 feasibility study reporting deployment/retrieval success, safety data and IPSS reductions.

Peer-reviewed article reporting results from the EXPANDER-1 trial.

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