Viveve Medical, Inc. · OTC:VIVE
Viveve Medical — Technical Presentation (2009)
16 slides from Viveve Medical's technical presentation, 2009
Slide 1: Radiofrequency Treatment of Vaginal Laxity – Nonsurgical Vaginal Tightening
Radiofrequency Treatment of Vaginal Laxity – Nonsurgical Vaginal Tightening Seth Jordan Herbst MD, Leah Millheiser MD, Rachel Pauls MD, Sandra Carson MD, Jonathan Parmer MD, Cynthia Willson RN, Roger Stern PhD and Bertha Chen MD
Slide 2: Disclosures
Disclosures • SJ Herbst - Consulting fee (Viveve) • RN Pauls, LS Millheiser, S Carson, B Chen- – Members of Scientific Advisory Board, stock options (Viveve) • J Parmer - Former employee, shareholder (Viveve) • C Willson - Employee, stock options (Viveve) • R Stern – Shareholder, stock options (Vive
Slide 3: Study Objectives
Study Objectives • Evaluate safety and tolerability of radiofrequency (RF) thermal therapy • Evaluate effectiveness as nonsurgical treatment to tighten the vaginal introitus in women with vaginal laxity
Slide 4: Study Participants: Major Eligibility Criteria
Study Participants • Major Eligibility Criteria – At least one or more full-term vaginal deliveries – Self-reported vaginal laxity* after deliveries described as “slightly loose, moderately loose or very loose” * Using Vaginal Laxity Questionnaire (VLQ)
Slide 5: Study Participants
Study Participants • 24 healthy, sexually active , pre-menopausal women, mean age 37 yr (range 27-44 yr) • Median 2 (1-3) full-term vaginal deliveries • Median 13.9 yr (1-24 yr) between first delivery and study screening • No chronic pelvic pain conditions (vaginismus, dyspareunia) • No evidence of
Slide 6: RF Device and Treatment Procedure
RF Device and Treatment Procedure • Heat delivered to submucosal tissue of introitus while simultaneous cryogen surface cooling protects the epithelial layer • Multiple RF pulses at overlapping intervals avoiding the urethral area
Slide 7: Treatment Procedures
Treatment Procedures • Office-based procedure, takes ~ 30 minutes • Only one RF treatment per subject • Safety evaluation-3 RF doses; 60, 75, 90 J/cm2
Slide 8: Outcome Assessments
Outcome Assessments • Safety: Clinic observations and pelvic exams at 10 days, 1 and 3 months after treatment • Effectiveness: – Vaginal Laxity Questionnaire (VLQ) • 7-point rating scale laxity/tightness (very loose to very tight) – Sexual Satisfaction Questionnaire (SSQ) • 6-point rating scale (non
Slide 9: Results: Safety
Results: Safety • All RF doses well tolerated – 18 of 24 subjects treated at highest level (90 J/cm2) • No topical anesthetics required • No adverse events
Slide 10: Results: Effectiveness for Vaginal Tightness
Results: Effectiveness for Vaginal Tightness • All 24 subjects reported one or more levels of improved vaginal tightness (VLQ) at Month 1 • Responses sustained or further improved at Month 3 compared to pre-treatment (p<0.001)
Slide 11: Changes in Vaginal Tightness after RF Treatment
Changes in Vaginal Tightness after RF Treatment Very tight [7], moderately tight [6], slightly tight [5], not tight or loose [4], slightly loose [3], moderately loose [2], very loose [1]. Data are mean with 95% confidence intervals (error bars). P values, Wilcoxon signed rank test.
Slide 12: Results: Effectiveness for Sexual Satisfaction
Results: Effectiveness for Sexual Satisfaction • At screening, 12 of 24 subjects reported decreased sexual satisfaction from vaginal intercourse (SSQ) after vaginal deliveries • At Months 1 and 3 after RF treatment, all reported improved satisfaction compared to pre-treatment (p≤0.002)
Slide 13: Subjects with Decreased Sexual Satisfaction after Vaginal Deliveries
Subjects with Decreased Sexual Satisfaction after Vaginal Deliveries Excellent [5], very good [4], good [3], fair [2], poor [1], none [0]. Values are mean ± 95% CI. P values, Wilcoxon signed rank test.
Slide 14: Personal Distress from Sexually Related Activities
Personal Distress from Sexually Related Activities • At Month 1 and 3 after RF treatment – Significantly decreased personal distress from sexually related activities (FSDS-R) (p<0.001)
Slide 15: Changes in FSDS-R Scores after RF Treatment
Personal Distress from Sexual Activity Changes in FSDS-R Scores after RF Treatment Data presented as mean ± 95% CI. (error bars) P values, paired t tests comparisons Months 1 and 3 versus Pre-treatment
Slide 16: Conclusions
Conclusions • RF procedures were safe and well tolerated • Procedure offers potential as a nonsurgical modality to improve tightness of the vaginal introitus • Subject self-reports indicated significantly….. - decreased sexual distress from sexual activity - improved vaginal tightness - improved sex