Orbix Medical receives CE mark for "internal bra"

The company has developed a minimally invasive aesthetic surgical product for sagging breasts.

Orbix Medical Ltd., which has developed the Breast Lifting Kit implant, has announced that it has obtained marketing approval in Europe. The company has developed an aesthetic surgical product for sagging breasts, and to support breasts which have been surgically enlarged.

"I carry out many breast enlargement and breast reconstruction procedures through full or partial mastectomy," said Orbix founder Dr. Eyal Gur, "The question of sagging breasts always comes up. When the breast is lifted during enlargement, it will almost always fall, because the weight pulls the breast down. Many women who have undergone surgery sue the surgeon because their breasts do not look the way they wanted. Although they're large, they had also hoped that they wuold be uplifted."

The breast's condition is a function of aging skin. Over the years, during periods of weight gain and loss, the breast loses its elasticity. Even women who do not undergo breast enlargement experience this at some stage. Breast lifting surgery, in which the skin is tightened, is possible, but over time, the breast will again sag.

Orbix's product is a silicon sheet that covers the breast tissue like a sub-dermal bra, which is sutured to the ribcage. "We realized that the support needed in this case was support of soft tissue to the bone, such as carried out in endoscopic surgery of the pelvic floor," says Orbix CEO Yossi Mazel.

Orbix was founded at Kiryat Shmona's Meytav Technological Incubator, which is now owned by Biomedix Incubator Ltd. (TASE:BMDX). In a trial in Israel and Belgium that included 30 women, some of whom underwent breast enlargement and others breast reduction, it was found that the results were maintained after several years. The women reported no pain beyond what would be expected in ordinary breast enlargement or breast reduction surgery.

Mazel says that doctors can use Orbix's product to create a naturally looking breast, whereas in normal breast surgery they tend to lift the breast higher than the ideal, in the knowledge that it will sag over time. Gur says that the product is barely felt, especially for C-cup and larger breasts.

Orbix has raised $4 million to date from private investors, who are not from the medical devices field, but were enthusiastic about the concept and the team.

Gur says, "We hope that our product will reach, in addition to women who go through surgery and want to keep the results, women who do not want to undergo breast lifting because it is a painful procedure, but would be interested in a minimally invasive procedure. We thought that women would say, 'What, you want to stick screws in my ribs?' but most of the women to whom I made a business presentation of the company were also interested in the product for themselves."

Orbix believes that the US Food and Drug Administration (FDA) will grant the product K510 fast track clinical trials, and that the company will begin the process with the FDA in 2014. The product's European market, which became available yesterday, accounts for 30% of the global market.

"For the time being, we cannot set up a global marketing network or pan-European pilot, but we can begin sales to demonstrate the product's commercial viability, in order to boost the company's value," says Mazel.

Published by Globes [online], Israel business news - www.globes-online.com - on November 5, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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