Healthcare Industry News:  Dermal Filler 

Devices Regulatory

 News Release - April 20, 2007

Evera Medical Receives CE Mark for Novel Lip Implant

FOSTER CITY, Calif., April 20 (HSMN NewsFeed) -- Evera Medical, maker of FulFil(TM), a novel saline-filled implant for tissue augmentation, today announced that the company has been granted the CE Mark, allowing the company to market its FulFil implant throughout the European Union, and that the first UK patient was treated by Dr. Lucy Glancey.

The CE mark certifies that FulFil, used for facial soft tissue augmentation, complies with applicable safety and quality standards. The first product in the FulFil line is a saline-filled lip implant for permanent reversible enlargement.

"We are extremely pleased to have received approval to market in Europe. This approval, which is based on extensive mechanical testing and the results of our international clinical trial, validates the safety and outcomes of FulFil treatment," said Michael D. Lesh MD, Chairman and CEO of Evera Medical. "The market for facial augmentation, especially lip enhancement, is large and growing. Our clinical data showed that the physicians who have implanted FulFil, and the patients who have been treated, are very satisfied with the results," Dr. Lesh added.

UK physician Dr. Lucy Glancey was the first in the European Union to treat a patient after Evera received the CE mark. "This implant represents a significant improvement over existing products such as temporary Dermal Fillers and facial implants made of stiffer synthetic material. The patient that I treated had a great outcome and I look forward to treating more patients and following them up for long term satisfaction," said Dr. Glancey, a cosmetic surgeon practicing in London.

The patented FulFil implant, constructed of a special multilayer polymer membrane. During patient treatment, it is filled with saline (the body's normal salt water), which can be added or removed until the desired degree of enhancement is achieved. Currently marketed lip implants can heal with excessive scarring, resulting in discomfort and stiffness. Due to the unique construction of FulFil, areas treated with the implant remain soft. Augmentation is permanent, reversible and patient outcomes are predictable. More than 200 patients have been treated worldwide, 50 of whom have been followed for over a year. "With over 400 FulFil units implanted, we have not had any infections or device ruptures," commented Dr. Lesh. "These are outstanding results for any tissue implant." FulFil is available in a number of sizes to accommodate a range of treatment areas.

Evera Medical, formerly Juva Medical, manufactures and markets the FulFil implant for soft tissue augmentation outside of the U.S. In the US, applications seeking a range of clearances are pending with the FDA. The FulFil implant is a unique, proprietary device intended to provide a permanent yet reversible alternative to the costly repeat treatments that can be required to achieve enduring tissue augmentation. The market for minimally invasive facial rejuvenation is at least one billion dollars, and growing by 20% per year in the US, and 40% per year in the UK.

Further information about the FulFil procedure is available at www.everamedical.com or by calling 650-525-9750.


Source: Evera Medical

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