Brava, LLC has conducted two clinical trials. The Lead Clinical Investigator for these trials was the world-renowned plastic & reconstructive surgeon, Dr. Thomas J. Baker. Results of the initial study were published in the journal of Plastic & Reconstructive Surgery, June 2000.

An overview of each is provided.

Clinical Trial 1998-1

The results of the initial clinical trial were published in the journal of Plastic & Reconstructive Surgery and later presented to the U.S. Food & Drug Administration. Seventeen healthy women participated and 12 completed the protocol. Five subjects were dismissed from the study due to their failure to follow the required protocol. Each participant was asked to adhere to a daily 10-hour application of the device over a 10-week period; this resulted in an average breast growth of 104cc as measured 15 months after termination of treatment. As illustrated in the Brava Action Graph below, participants saw a progressive increase in their breasts and at 10 effective weeks of treatment reached their peak size. They were then instructed to remove the System and were re-measured four weeks later. Final growth averaged 104cc.

NOTE: For the sake of clarity 100cc is roughly equivalent to 1 bra-cup size.

Peak Growth. After completing the effective 10-week treatment (14.7 average weeks of wear), Brava participants experienced an average volume increase of 161cc per breast, which included both true tissue growth and edema (swelling) (Results ranged from 114-196cc depending on the individual wear pattern of the device.)

Relative-size Increase. Participants' initial breast size (baseline) ranged from 96cc to 282cc. After completing the 10-week effective treatment, the average increase in volume, at peak, was 100% (% increase ranged from 29% to 300%) from baseline.

Final Growth. Final growth was measured four weeks after discontinuing use of the device. The participants had decreased from their peak growth as the edema (swelling) dissipated. This left them with an average final volume increase of 104cc (with a range of 34-158cc of growth). This represents approximately a 50% increase in breast size from their initial breast size (baseline). This average of 104cc correlates to an increase of approximately 1 cup size for all subjects.

Participant's chest circumference measurements were taken at the nipple and at the inframammary fold (the crease under the breast) before and after treatment. Measurements taken at Final Growth showed an average volume increase of 65%, which remained on long-term follow-up.

(Subsequent to the publication of these results and approximately 22 months after stopped wearing the device, participants were measured. It was found that participants maintained 95% of the growth that they had experienced approximately 4-weeks after they had stopped wearing the system.)

Satisfaction. All participants in the study were satisfied with the results. Participants believed that their breasts had not only increased in volume but had also been lifted to some extent. All felt more comfortable with their body image and 100% indicated they would recommend the product to a friend. The before and after responses noted on the Satisfaction Questionnaire were highly significant for increased satisfaction in self-esteem.

Conclusion. After reviewing the system as a 510(k) Class II Medical Device, the U.S. Food and Drug Administration responded by allowing the sale of the BRAVA System. The system has met all FDA marketing requirements, and the FDA has decided not to regulate the system at this time.

Clinical Trial 2001-1

The second clinical trial enrolled 125 women at 6 clinical research centers in four major U.S. cities. This study was undertaken to demonstrate safety and efficacy in a larger patient population and to test product improvements. Each was asked to wear the system everyday, for at least 10 or more hours per day and for at least 10 consecutive weeks. Bead displacement measurement of breast volume and photo-documentation were done before, throughout the study, and upon study termination. Final recordings were obtained at least one month after cessation of treatment only after unchanged breast volume measurements two weeks apart confirmed stable enlargement. Results were correlated with demographic and physical factors, with duration of treatment and with daily compliance as recorded by the microchip in the device.

95 of the 125 enrolled participants completed the study. The reasons for withdrawal were: inability to comply with the required hours of wear (n=24), refractory dermatitis (n=3), and greater than 5% body weight change (n=3). The majority of non-compliance withdrawals occurred within two weeks of initiating treatment. The 95 participants were asked to discontinue use at an effective 10-weeks of treatment were measured for final results at week 13-14. Many chose to wear the System for an additional cycle in the hopes of obtaining additional breast growth; all did receive additional growth in the second cycle. The average wear for all participants was 13.5 weeks and the average daily wear as 11 hours per day.

Final Results: Measurements were taken two weeks apart one month after cessation of treatment. Ninety-five women completed at least 10 weeks of treatment. The average wear was 13.5 weeks (range of use 10-26 weeks). At the end of the treatment, some of the volume gain gained was edema and after the breast increase stabilized, the final results mirrored the results from the initial study with a slightly higher average of 108 cc (final growth ranged from 30 cc to 250 cc).

The growth represented an average 80% increase in breast size (ranging from 11% to 290%). Fourteen women achieved an excellent outcome as their breast volume more than doubled and had an absolute volume gain greater than 120 cc; 43 achieved a very good result with greater than 50% increase over initial breast size and net volume gain greater than 100 cc; 27 achieved a good result, greater than 50% increase over initial breast size and net volume gain greater than 80 cc; only 11 had a marginal outcome, less than 50% increase over initial breast size and net volume gain less than 80 cc.

Parity, body fat content and initial breast size had a minor positive effect that was not statistically significant, but what was most significant in determining breast growth was the intensity (hours worn per day) and duration of treatment (weeks of use).

Conclusion. This study confirms that external tissue expansion of the breast with BRAVA leads to larger fuller breasts. Like other expansion procedures used in medicine, true tissue growth is slow and requires sustained tension. Daily intensive compliance and overall duration of treatment are the main predictors of positive outcome. This non-invasive tissue-engineering alternative makes it possible for women to increase their breast size at the rate of 1-1.5 cc per day. The more the system is worn, the more breast tissue results.