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NEW BRAVA MEDICAL AND SCIENTIFIC STUDIES

The Brava System and its revolutionary technology are presently being utilized in a number of new and exciting medical and scientific studies.

What follows are several on-going studies that are attracting significant attention in the medical community.

I. THE BRAVA BREAST ENHANCEMENT AND SHAPING SYSTEM BENEFIT STUDY

The Brava Breast Enhancement and Shaping System (Brava System) was introduced in 2001 and has now been used by over 30,000 women. Several studies have shown that women with either breast augmentation or breast reduction surgery are typically found to experience lower levels of breast cancer. The reasons for these findings are not well understood. At the beginning of the study in 2005, only one reported case of breast cancer among Brava users had been received from well over 10,000 women who up to that time used the product in the US.

The primary objective of this pilot study is to determine whether use of the Brava System produces a similar result. Unlike breast augmentation and reduction, the Brava System does not involve surgery. This device is used external to the body and applies negative pressure to the breasts.

The pilot study comprised of two components:

Physician’s Survey
Cancer Registry Study

Physician’s Survey

In April 2005, a survey was mailed to 250 randomly selected current and past Brava Authorized Physicians. The survey asked if any of their Brava patients had experienced one of several breast ailments since their use of Brava. Follow-up mailings and telephone calls were performed for non-respondents. In June 2005, an additional 84 physicians were sent the survey, again with follow-up for an incomplete response.

As of January 2006, 229 physicians (69%) representing 1,851 patients had completed and returned the survey. The results of the survey will be analyzed to compare the number of breast cancers reported by the physicians with the number that would be expected among women in general.

Cancer Registry Study

A question that may arise from the Physician’s Survey is whether these physicians would necessarily be aware of a woman who developed breast cancer years later. To address that concern, Brava is performing another study coordinated at the University of Southern California School Of Medicine.

Each state in the US requires complete reporting of newly diagnosed cancers to the states health department. Utilizing a computerized system developed for this purpose, a group of individuals, such as Brava patients, can be compared against the state cancer registry file to determine which individuals have been diagnosed with cancer. Careful review and approval of this type of study must be performed by the state health department and no information on the identities of cancer patients will be released to Brava. As with the physician’s study, the number of breast cancers found will be compared with the number that would have been expected among women in general. Once these comparisons have been completed in several states, the results will be summarized for a scientific presentation.

II. BRAVA TECHNOLOGY TO REDUCE MOTION ARTIFACTS ON CONTRAST MR IMAGING OF THE BREAST

In conjunction with Researchers from the Massachusetts Institute of Technology and Brigham and Women’s Hospital (Harvard Medical School), a major research project is underway of the Brava System’s effect (as a negative pressure fixation device) on improving MR Imaging of women’s breasts. With the Brava System’s effect on the enhancement to the MR Imaging, it is hypothesized that it would make the diagnosis of breast abnormalities clearer.

When using the Brava System during the MR Imaging, it was found to stabilize the breasts and expand the breast tissue, which created clearer images. Additionally, patients of the test have found that when wearing the device during MR Imaging, it improved their comfort during the procedure.

The study is presently being submitted for publication in a major medical journal.

III. BRAVA SYSTEM FOR PREPARING SOFT TISSUE FOR GRAFTING, ENHANCING GRAFTING RESULTS, AND GRAFTING AUTOLOGOUS FAT TO SOFT TISSUE SUCH AS BREASTS

The Brava System is presently being used in a major clinical study by leading Plastic Surgeons in the U.S. and Europe, to assist in the transfer of Autologous Fat from other parts of the body (e.g. stomach and thighs) to the breasts.

This revolutionary study is on-going with encouraging preliminary results. The scientific theory is that the Brava System helps enhance the endurance and the survival of the new cells that are grafted into the breasts from other parts of the body. The Brava System also allows for a greater size increase in the breasts by allowing a greater amount of cells to survive the fat transplant due to better blood circulation to the area and the expansion of tissue in the breast area that will accommodate the transfer of the new Autogolgous Fat cells.

The preliminary results have been presented at a major medical conference and the study is presently being submitted for publication in a major medical journal. To learn more about this clinical trial study, http://www.clinicaltrials.gov/ct/show/NCT00466765?order=1 .

Additional information: In the October 1, 2008 issue of Cosmetic Surgery Times, the article, "A look at global trends in breast augmentation” authored by Karen Donley-Hayes. http://cosmeticsurgerytimes.modernmedicine.com/cosmeticsurgerytimes/article/articleDetail.jsp?id=553790 addresses the option of Brava enhanced fat grafting to the breasts.