Viveve Medical, Inc. · OTC:VIVE
Viveve Medical — ISSM 2014
21 slides from Viveve Medical's conference presentation, October 2014
Slide 1: Women's sexual health. It matters.
Women’s sexual health. It matters. Michael L Krychman, MD Executive Director of the Southern California Center for Sexual health and Survivorship Medicine Associate Clinical Attending UCI California, CA USA
Slide 2: Disclosures
Disclosures • Dr. Michael L Krychman wishes to disclose the following: He is the Chief Medical Consultant for Viveve Medical, Inc, and chairs the Company’s Medical Advisory Board. • This research was funded by Viveve Medical Inc 2
Slide 3: The Condition, The Problem, and Current Solutions
The Condition, The Problem, and Current Solutions • Vaginal childbirth permanently stretches vaginal tissue • Resulting looseness can cause: • diminished physical sensation during intercourse • reduction of sexual satisfaction • change in relationship with her sexual partner • Infrequently discussed
Slide 4: The Viveve Non-Surgical Solution
The Viveve Non-Surgical Solution • Patented, proven, reverse-thermal gradient technology • Radiofrequency (“RF”) generator with integrated cooling module • Hand piece and disposable treatment tip 4
Slide 5: Treatment Protocol
Treatment Protocol Think of vaginal opening as face of a clock • Place treatment tip at 1 o’clock position immediately behind vaginal opening • Depress foot pedal to delivery 3 phased pulse (cooling/heating/cooling) • Rotate treatment tip 1 cm clockwise and deliver 3 phased pulse • Repeat until trea
Slide 6: Procedure Benefits
Procedure Benefits • Non-surgical • In-office, 30 minute treatment, can be repeated • Simple and safe with no anesthesia required • No downtime 6
Slide 7: Patient Reported Physical Changes After Pregnancy (Physician Perspective)
Patient Reported Physical Changes After Pregnancy (Physician Perspective) Percentage of respondents Vaginal Laxity or Weight Urinary Loose or Stretch Sagging Fecal Other change of Gain Incontinence Flabby Marks Breasts Incontinence physician Stomach sensation Viveve Quantitative Physician Research o
Slide 8: Past
Past 8 © 2009 Viveve. Contents are confidential.
Slide 9: Clinical Support
Clinical Support • Sheep study demonstrated collagen remodeling • No evidence of necrosis or scarring • Clear evidence of collagen reformation • First in Women Non-Significant Risk IRB study demonstrated safety and efficacy • Widely accepted research • Six poster presentations (ACOG, AUGS, ISSWSH, I
Slide 10: Treatment Paradigm: Vaginal Laxity
Treatment Paradigm: Vaginal Laxity • Behavioral /Kegel Exercises • Significant patient directed teaching • Time consuming, Poor efficacy and compliance • Addresses pelvic floor muscles, not introital tissue • Viveve Treatment • Non-invasive 30 minute office based procedure • Quick and easy recovery
Slide 11: Mechanism of Action
Mechanism of Action Da eet ee ee Comme Hee te | Done
Slide 12: First In Woman Study
First In Woman Study Subject Self Report ─ Vaginal Laxity/Tightness Questionnaire (VLQ) Vaginal Laxity Questionnaire (VLQ), subject’s response category (corresponding numerical code): Very Tight (7), Moderately Tight (6), Slightly Tight (5), Neither Tight nor Loose (4), Slightly Loose (3), Moderatel
Slide 13: First In Woman Study (cont'd)
First In Woman Study (cont’d) Subject Self Report─ Sexual Satisfaction Questionnaire (SSQ) Cohort A – 12 patients who reported decrease in sexual satisfaction post birth Sexual satisfaction: Excellent [5], very good [4], good [3], fair [2], poor [1], none [0] 13
Slide 14: Present
Present 14
Slide 15: Present
Present • Currently available in Hong Kong, Japan, and Canada • CE mark allows Viveve System sales in Europe; launching into select European countries in early 2015 • Working with FDA to finalize IDE study protocol for U.S. • To date, over 300 procedures performed without SAEs 15 © 2009 Viveve. Cont
Slide 16: Future
Future 16 © 2009 Viveve. Contents are confidential.
Slide 17: VIVEVE I Study
VIVEVE I Study VIveve Treatment of the Vaginal Introitus to EValuate Efficacy Post-Market, Parallel Group Study Design Design: • A prospective, longitudinal, randomized, single-blind, sham controlled clinical study • Designed to demonstrate that active treatment (i.e., Viveve Procedure) is superior
Slide 18: VIVEVE I Study
VIVEVE I Study Number of Evaluable Subjects to be Enrolled • 113 subjects in 2:1 randomization scheme (75 subjects in the active arm and 38 subjects in the sham arm) Clinical Sites • Up to ten (10) clinical sites Study Population • Pre-menopausal females 18 years of age or older who have experienced
Slide 19: VIVEVE I Study
VIVEVE I Study Primary Effectiveness Endpoint • The proportion of subjects in the active arm as compared to the proportion of the subjects in the sham arm reporting no vaginal laxity at six months post-intervention • “No vaginal laxity” is operationally defined as a score > 4 on the VSQ, a patient r
Slide 20: VIVEVE I Study
VIVEVE I Study Secondary Effectiveness Endpoints • The percent change in Vaginal Introitus Laxity Inventory (VALI) mean score from baseline to six months post- intervention in the active arm compared to the percent change in the Vaginal Introitus Laxity Inventory (VALI) mean score from baseline to s
Slide 21: Thank you for your kind attention Questions and Answers
Thank you for your kind attention Questions and Answers 21 © 2009 Viveve. Contents are confidential.