Ex Vivo & In Vivo GLP Studies
Viveve has been actively working with the FDA over the last 2 years to address any potential safety concerns. Results from multiple Good Laboratory Practice (GLP) studies include:
- “Worst case” ex-vivo ovine evaluation showed vaginal and peri-vaginal tissue safety at multiple dose levels at different vaginal tissue thickness.
- Documented fibroblast activation and collagen remodeling showed no cellular damage in an ovine model.
- Tissue temperatures following RF administration in an in-vivo ovine model align tissue restoration through connective tissue layer; safety confirmed by histology through all vaginal and surrounding tissues.
- Tissue temperatures elevated from mucosa/lamina propria transition zone to lamina propria/muscularis transition zone, with minimal heating in muscularis. Shown with fiber optic temperature probes surgical placed in ovine, with temperature directly assessed at various tissue layers.
- Treatment with the Viveve RF device did not result in temperatures that would be expected to cause cellular damage, also supported by histopathology evaluations.
Randomized, Blinded, Controlled Clinical Studies
VIVEVE I STUDY
The largest randomized, double-blind and sham-controlled study in the vaginal rejuvenation space with 164 patients. Study showed a significant improvement in arousal, lubrication and orgasm versus the sham treatment. Pilot study showed sustained results out to 12-months.
VIVEVE II STUDY
The not yet completed VIVEVE II Study is testing the safety and effectiveness of the Viveve Treatment for women who are experiencing decreased sexual satisfaction following vaginal childbirth.