Urotronic
Medical device company focused on development and commercialization of drug-coated balloon catheter technologies for interventional urology. Works on catheter-based minimally invasive therapies for urethral strictures and benign prostatic hyperplasia (BPH), conducts multicenter clinical trials, publishes clinical data, and pursues regulatory approvals in multiple jurisdictions.
Industries
N/A
Nr. of Employees
small (1-50)
Urotronic
Patents
Products
Urethral drug-coated balloon catheter
Balloon dilation catheter with a drug-coated surface designed for treatment of male urethral strictures; provides mechanical dilation with localized antiproliferative drug delivery.
Prostatic dilation drug-coated balloon catheter system
Catheter system using a double-lobe balloon to perform mechanical dilation of the prostatic urethra combined with localized antiproliferative drug delivery intended to maintain luminal patency during healing.
Basic urological balloon dilation catheter
Non-drug-coated balloon dilation catheter for general urological dilation procedures; provided with IFU documentation and multilingual support.
Urethral drug-coated balloon catheter
Balloon dilation catheter with a drug-coated surface designed for treatment of male urethral strictures; provides mechanical dilation with localized antiproliferative drug delivery.
Prostatic dilation drug-coated balloon catheter system
Catheter system using a double-lobe balloon to perform mechanical dilation of the prostatic urethra combined with localized antiproliferative drug delivery intended to maintain luminal patency during healing.
Basic urological balloon dilation catheter
Non-drug-coated balloon dilation catheter for general urological dilation procedures; provided with IFU documentation and multilingual support.
Expertise Areas
- Interventional urology device development
- Clinical trial design and execution (randomized, blinded, multicenter)
- Localized antiproliferative drug delivery on implantable/temporary devices
- Regulatory submissions and market approvals (FDA, CE Mark, country approvals)
Key Technologies
- Drug-coated balloon (DCB) catheters
- Localized paclitaxel delivery
- Double-lobe balloon mechanical dilation
- Catheter-based minimally invasive surgical therapies (MIST)
News & Updates
Presentation of 4-year and 12-month clinical outcomes from EVEREST and PINNACLE trials evaluating the prostatic dilation drug-coated balloon system.
Publication of twelve-month randomized trial data evaluating safety, effectiveness and durability of the prostatic dilation drug-coated balloon system; results featured in the Journal of Urology.
U.S. Food and Drug Administration approval of the prostatic dilation drug-coated balloon catheter system for treatment of lower urinary tract symptoms secondary to BPH.
Completion of the first commercial outpatient procedure using the prostatic dilation drug-coated balloon system in Toronto, Canada.
Presentation of 4-year and 12-month clinical outcomes from EVEREST and PINNACLE trials evaluating the prostatic dilation drug-coated balloon system.
Publication of twelve-month randomized trial data evaluating safety, effectiveness and durability of the prostatic dilation drug-coated balloon system; results featured in the Journal of Urology.
U.S. Food and Drug Administration approval of the prostatic dilation drug-coated balloon catheter system for treatment of lower urinary tract symptoms secondary to BPH.
Completion of the first commercial outpatient procedure using the prostatic dilation drug-coated balloon system in Toronto, Canada.