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newflow

11/27/18 2:55 PM

#161530 RE: Alley-oop #161526

FEMALES GET MORE PAIN AND ITS WORKING BETTER FOR THEM.

ACTIPATCH is working better when there is actually MORE PAIN, IN THEIR OWN WORDS.

"The medical community acknowledges that there are gender differences in responses to pain therapies [1], and importantly, that women experience pain more intensely than men [2]. Moreover, women are at a greater risk of using opioids than men to combat chronic pain [3]. Given the risks inherent with opioid use, as well as limited efficacy of other pharmacotherapy options such as NSAID’s and topicals, there is a dire need for a safe and effective non-pharmacological pain therapy like ActiPatch. Gender-level analysis of the prior ActiPatch clinical data revealed that there indeed were differences in treatment effects between men and women, with women reporting more pain relief than men. The company intends to leverage these findings and resubmit the 510(k) application for a more specific indication: relief of musculoskeletal pain for women. Our sales data are compatible with the observation that women get substantial relief in that about 70% of our sales are to women.