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:
- Ex-vivo ovine evaluation showed vaginal and peri-vaginal tissue safety at multiple dose levels at different vaginal tissue thickness.
- Documented fibroblast activation, collagen remodeling, 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.