Keller Medical's silicone breast implant delivery device receives European CE Mark approval

May 6 2011

Keller Medical, Inc., a privately held company, announced today that it has received CE approval for the Keller Funnel™ gel implant delivery device. Receiving the CE mark allows the Company to begin marketing and distributing the product in all European member (EU) states. Approved by the FDA in August 2009 as a single use device, Keller Medical has tripled its Funnel sales in a year over year comparison and captured 20% of U.S. surgeons performing silicone breast implant augmentations since its launch 20 months ago.

The Keller Funnel™ is a cone-shaped, hydrophilically coated nylon device that provides surgeons with a low friction insertion method for a range of implant styles, sizes and shapes. The product works with smooth round, textured, form stable, pectoral and gluteal implants and provides both surgeons and patients with multiple benefits.

The majority of breast augmentations performed annually in the EU are completed with silicone implants because they more closely resemble the look and feel of natural breast tissue. In the US, the trend for silicone implants continues to grow, with nearly 60% of last year's 283K breast augmentations performed using silicone implants. According to a recent survey of 200 surgeons (www.funnelstudy.com), the Keller Funnel™, as reported by survey participants, allows doctors to:

• shorten incision lengths and increase placement options
• employ a no-touch technique believed by respondents to reduce infection rates
• significantly reduce force applied to the implant shell which may lessen rupture occurrence
• decrease operating room time

"This approval marks another important milestone in our company's short but successful history," said Keller Medical CEO Howard Preissman. "Currently we are in discussions with several EU distribution partners and look to solidify agreements in the near future while completing country specific registration requirements."

Additionally, the Company recently signed an exclusive agreement with Mentor, maker of advanced breast implants, to distribute the Keller Funnel™ in Canada, strengthening its ability to increase product market share in North America.