Minerva IPO Presentation Deck
Comparison to FDA assigned OPC (Objective Performance Criteria)
Minerva Efficacy was "Statistically Significantly Greater" Compared to OPC Control Group¹
Company
Device Name
Energy
Uterine anatomy
Mean
procedure time
Amenorrhea rate*
zero bleeding
Success rate**
Snormal bleeding
Hysterectomy rate
(36-mo. post treatment)
Minerva
Surgical
Minerva ES
PlasmaSense
Normal
3.1 min
71.6%
91.8%
0.9%
Hologic
Novasure
Radio
Frequency
Normal
5 min
36.0%
77.7%
6.3%
Objective Performance Criteria Group
J&J
! Ethicon Inc.
ThermaChoicet
Hot Water Balloon
Cooper
Minerva I
Surgical I Surgical
Her Option
Cryoablation
Normal
>10 min
22.0%
67.4%
8.3%
I
Genesys HTA
Heated Saline
Normal and
Abnormal
26.4 min
35.0%
68.4%
10.2%
Source: FDA approved efficacy rates- Instructions for Use and Summary of Safety and Effectiveness Data
*At 12-month follow up; amenorrhea is ZERO bleeding
**At 12-month follow up; success rate is defined as s normal bleeding level, based on PBLAC diary scores
* Minerva pivotal study control group for Minerva ES was the FDA-assigned OPC (Objective Performance Criteria).
Control group patients for Novasure, Her Option, Genesys HTA, ThermaChoice, and MEA studies were all treated with rollerball endometrial ablation.
I
I
I
I
Normal
27.4 min
13.2%
80.2%
8.6%
Microsulis
Medical Ltd.
MEAT
Microwave
Normal
3.45 min
55.3%
87%
no data
available
† Product no longer on the market
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