Doctor Designed Clinically Proven

Enhance is a discrete, wearable, hands-free device that is placed over the clitoris for thirty minutes prior to sexual activity. Enhance creates a gentle suction that is intended to increase blood flow to the clitoris and improve the body's natural sexual response. Enhance is easy to use, comfortable to wear, and lets you go about your daily activities while getting ready for sex. Results from a clinical study of women who experience difficulty with sexual desire, arousal and lubrication, orgasm, and sexual satisfaction show improvement in overall sexual satisfaction of 79%, improvment in arousal and lubrication of 82%, improvement in orgasm of 84%, and improvement in sexual desire of 63%.

When available each Enhance should be used four times and then thrown away. For convenience, we will offer monthly subscriptions to ensure you’ll always have a working Enhamce when needed. Every Enhance will be shipped with a childproof container that easily fits into a pocket or small clutch.

About Enhance

Clitoral blood flow plays an important role infemale sexual arousal and overall sexual satisfaction. In norm.al females, sexual arousal results in smooth muscle relaxation and arterial vasodilation within the clitoris. The result is an increase in blood flow and intra-cavernous pressure leading to tumescence and extrusion of the glans clitoris. Certain physical conditions that cause constriction in the vaginal and clitoral arteries may interfere with or prevent women from achieving clitoral tumescence and subsequent sexual arousal. These include hypertension, elevated cholesterol, diabetes mellitus, smoking and arterial occlusive disease. Other conditions such as neurological and hormonal abnormalities may interfere with normal female sexual response. For the excitement and orgasmic reflexes to be activated, a stimulus must be applied to the clitoris. This stimulus must be of sufficient intensity and duration to reach the threshold for the sensory nerve stimulation reflex. A non-pharmacological approach to treatment which causes increased blood flow to the clitoris and subsequent stimulation of the sensory nerve endings would be beneficial to the large group of women with symptoms related to diminished sexual arousal, desire and orgasmic function.

Currently, the most common sexual devices are vibrators which create friction against the clitoris. These devices are, however, cumbersome and less than discrete to use and only partially effective in a select group of women. A more effective method of increasing clitoral engorgement, especially in women suffering from Female Sexual Arousal Disorder (FSAD) and Orgasmic Dysfunction (OD) is through the use of suction. A partial vacuum produced over the clitoris creates significant negative pressure in the organ. This, in turn, promotes clitoral arterial inflow, resulting inincreased vascular engorgement and sexual arousal. This effect is particularly pronounced in women with FSAD and OD where clinical studies have demonstrated a four fold increase in arterial blood flow when vacuum is applied.

The Enhance Clitoral Stimulation Aid (Enhance CSA) is a soft, simple, disposable, noninvasive suction cup which assists in achieving and maintaining clitoral tumescence, increases blood flow to the clitoris and ultimately enhances arousal, desire and orgasm. Similar to a suction  cup, air is forced out of the device cap while it is positioned over the clitoris. When the cap is released, the device self-adheres to the anterior vaginal wall over the clitoris via the vacuum created by the device. The amount of vacuum can be controlled by the degree of compression of the cap. To enhance adhesion and mechanical function of the device, a bio-compatible vaginal lubricant is utilized on the rim. The amount of negative pressure generated by the device can be varied by the user but is sufficient to create tumescence of the clitoris with enhanced sensation, increased lubrication, increased orgasm, heightened sexual desire and improved sexual arousal.

Clinical Results

A. BACKGROUND

The Enhance CSA underwent a Multicenter Non-significant Risk Clinical and OTC Label Comprehension 510(k) Study for FDA clearance in 2004-2005. The Label Comprehension Test portion of the Study was designed to test subjects ability to 1. correctly self-select for use of this product to treat symptoms related to female sexual dysfunction and 2. understand and correctly use the product as outlined in the Consumer Instruction Guide. The Clinical portion of the Study was designed to test the safety and efficacy of the device in an OTC environment.

B. SUMMARY OF LABEL COMPREHENSION TESTING

Referring to the self-selection portion, respondents demonstrated very strong comprehension as to whether they could personally use Enhance. One hundred percent (100%) correctly indicated that Enhance can be used to treat symptoms of female sexual dysfunction. When asked whether they could use the product for their own sexual symptoms based on the product's carton and Instructions For Use (IFU),  100% of subjects appropriately self-selected themselves as candidates for Enhance based upon clinical evaluation by the Investigational Sites. Referring to correct product use, the vast majority of the subjects correctly answered questions related to how the device could be used in a safe and effective matmer.

C.   SUMMARY OF CLINICAL TESTING

Enhance CSA underwent clinical testing designed to test the safety and efficacy of the device in an OTC environment. Objective measures included the Female Sexual Function Index (FSFI) scores and subjective measures included Sexual Life Quality Questionnaire (SLQQ) and Female Intervention Efficacy Index(FIEI) scores.

As an objective outcomes measure, the FSFI Questionnaire is a 29 question,validated study which measures Total Female Sexual Dysfunction as well as the sub-domains of Desire, Arousal, Lubrication, Orgasm, Satisfaction and Pain. Subjects completed an FSFI Questionnaire as a baseline (Pre-Evaluation) and after device utilization (Post-Evaluation). The Study defined individual success as a 20% or greater improvement at Post-Evaluation compared to Pre-Evaluation Total FSFI score or any of the sub-domain scores. Individual success was achieved in Overall Improvement in Sexual Function in 87% of subjects and in the sub-domains of Desire 63%, Arousal 92%, Lubrication 82%, Orgasm 84%, Satisfaction 79% and Pain 55% of subjects.

For subjective outcome measures, subjects completed a SLQQ after using the device. This 11 question, validated quality oflife questionnaire measures improvement in overall sexual experience related to love-making and orgasm after any intervention . Eighty-seven (87%) of subjects noted   an improvement in score signifying improved sexual quality of life and satisfaction while wearing  Enhance CSA. Subjects also completed an FIEI diary after device use.This 6 question, validated diary evaluates each sexual event noting improvement , no change, or worsening in vaginal lubrication, genital sensitivity, ability to reach orgasm, and overall sexual experience thereby measuring the intervention's  effect on the treatment of sexual dysfunction. Study results demonstrated a 74% improvement in lubrication, 82% increase in genital sensitivity, 66% increase in pleasure associated with intercourse, 63% improvement in orgasm and 82% increase in overall sexual satisfaction. Ninety­ two percent (92%) of subjects claimed they would like to continue using the device after the Study was completed.

No unanticipated adverse events occurred in the Study. An overall incidence of 1.3% vaginal irritation was noted and, in all cases was mild, transient and resolved when the device was repositioned over the clitoris.

FDA Clearance

Enhance CSA has received FDA OTC market clearance (K043480) and is indicated for "women with the following symptoms of Female Sexual Dysfunction: diminished Arousal (and Lubrication), Sexual Desire and ability to achieve Orgasm.