Bioresorbable Urethral Implant with a unique composition
- 70% CMC gel
- 30% Polycaprolactone (PCL) microspheres
Minimally invasive procedure
Proven safety and efficacy
- Safe product components with a long safety history in numerous CE marked and FDA approved bioresorbable medical devices
- Soft bioresorbable (non-cross-linked) medical polymer: polycaprolactone, in a tailor made aqueous CMC gel carrier
- Gel carrier components Generally Recognized As Safe (GRAS) by the USA FDA
Optimal biocompatibility
- Sensitivity testing not required due to a non-animal, non-bacterial and non-human derived product
- Due to microsphere size, spherical shape, smooth surface and chain scission (hydrolysis) as opposed to degradation
Bi-phasic hydrolytic bioresorption
- Purely hydrolysis-based; non-enzymatic process
- PCL microspheres remain in-situ, resulting in stable and sustained performance
- Second-phase results in full bioresorption of small PCL chains (6-hydroxy caproic acid) via the normal citric acid cycle; reduction to CO2 and H2O)
Totally bioresorbable
- Non-permanent microspheres
- As shown by radio-labelled PCL studies
- Reduced risk of long-term complications when compared to permanent implants
Urolon is a new class of urethral injectables. Its composition gives an immediate bulking effect primarily from the CMC gel carrier (70%) and sustained performance due to highly biocompatible PCL microspheres (30%)10-11. Combined, these unique advantages position Urolon as an ideal, first-choice and minimally invasive treatment option for women with mild to moderate SUI.