News

INAMED Receives FDA Approval for CosmoDerm and CosmoPlast Human Collagen Dermal Filler Products

Santa Barbara, Calif., March 12, 2003 - Inamed Corporation (Nasdaq: IMDC), a global healthcare company and the market leader in the popular dermal filler market, today announced that it has received approval from the U.S. Food and Drug Administration to begin marketing and distribution of its new CosmoDerm™ and CosmoPlast™ human collagen products. CosmoDerm and CosmoPlast have been approved for the correction of facial wrinkles, acne scars and other soft tissue contour deficiencies, as well as for restoration of the lip border.

CosmoDerm and CosmoPlast are the first commercially available, FDA-approved dermal fillers in the United States that do not require a skin test prior to use. Based on more than 20 years of research into the science of the skin, CosmoDerm and CosmoPlast are new,
innovative treatments for facial rejuvenation. CosmoDerm and CosmoPlast contain human collagen purified from human dermal tissue and manufactured under controlled laboratory conditions. CosmoDerm and CosmoPlast do not require a pre-treatment skin test and are
uniquely formulated with an anesthetic for patient comfort. As a result, CosmoDerm and CosmoPlast provide new options to meet the need for a same-day, single-visit treatment.

Per the recent Inamed Corporation Press Release, 'CosmoDerm is the non-cross-linked formulation used in the treatment of superficial lines, whereas CosmoPlast is cross-linked and is primarily used in the treatment of more pronounced wrinkles. CosmoDerm and
CosmoPlast previously received regulatory approval from the Canadian health authorities in December 2002.'

 

TATTOO and PIGMENTED [CONGENITAL] LESION REMOVAL by LASER

There are three types of tattoos: professional, amateur, and traumatic. Pigment is the laser’s target; it absorbs the light energy from the brief laser pulse; this energy is transformed into heat energy and is released to the surrounding tissue over a period of time that is just enough to destroy the indicated target, but not enough to injure the adjacent "innocent" tissue. Soon the splintered pigment particles are engulfed by the body’s defense mechanism cells called macrophages. This process of clearing takes several weeks. The client returns to Clinic for a second or subsequent treatment so that the next level of pigment (which was originally "below" the level just treated) can be eliminated. And so on. Most tattoo colors can be treated with laser, except yellow and white, and more recently, the "neon" white. There are several lasers on the market that have been used to remove tattoos. The Q-switched Ruby by Spectrum is the most time tested, the safest and most
effective. The Alexandrite is similar to Ruby but not quite as effective. The third type is Nd Yag 1064 /532, but this laser may cause bleeding and scarring.

Some congenital pigmented lesions may also be treated by laser. Some cannot, such as moles, which the Clinic refers to Dermatologists or Surgical specialists. The skin has a "genetic memory". This means that there must be adequate skin protection fromsun exposure [UVA & UVB] after the laser treatments. Otherwise, some of the pigment may return to the originally treated area.

Recent press releases and Media coverage describing the new Laser Hair Removal Systems

The E2000 has received clearance from the United States Food and Drug Administration (FDA) for providing "permanent hair reduction." Clinic is the first private facility in New England using these advanced laser systems.

The Wall Street (Health) Journal Monday April 5, 1999, page B1, mentions the new system's speed as particularly important in the treatment of large areas such as back and legs, which can be done during a lunch hour. Clinic& rsquo's new lasers use a longer pulse duration and controlled sub-zero cooling to help protect the skin. Clinic is now able to remove unwanted body and facial hair at the rate of one square inch per second! That's the speed of light. Another technological advance and safety feature in this "smart laser" technology is "contact sensing," in which the laser energy is triggered by sensing optimal epidermal temperature, assisting the user in developing the most desirable long-term effect, while also maximizing laser safety. With these features together in one laser for the first time, Clinic clients are guaranteed treatment with the most effective laser hair removal system ever.