Medical Device Daily Associate Managing Editor

SAN FRANCISCO — The aesthetics market is one that some med-tech purists might turn up their noses at. However, the smell of success emanating from this promising sector might cause them to salivate once they realize how lucrative the space can be.

Making their pitches at this week's JP Morgan Healthcare Conference were established aesthetics player Inamed (Santa Barbara, California) and promising privately held newcomer Thermage (Hayward, California).

Inamed, a global healthcare company with more than 25 years of experience, develops breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the Lap-Band system for morbid obesity.

According to President and CEO Nick Teti, Inamed will have several exciting new milestones to look forward to this year.

He said the company's Captique dermal filler will be launched in the U.S. within the next few weeks.

Captique, based on Genzyme's (Cambridge, Massachusetts) non-animal stabilized hyaluronic acid technology, was granted U.S. marketing clearance in late November. It is indicated for the correction of moderate-to-severe facial wrinkles and is manufactured by Genzyme. Inamed is Genzyme's exclusive U.S. marketing and distribution partner for the product.

The company also reported that it filed a premarket approval application (PMA) with the FDA for its Bio-Dimensional Cohesive Gel Matrix breast implants. These next-generation breast implants are designed for memory and shape retention and are now in the third year of patient follow-up in the U.S.

Another key event disclosed in December is a meeting with the FDA's Plastic Surgery Devices Advisory Panel, tentatively scheduled for April.

Inamed's silicone gel-filled breast implants PMA was reviewed and recommended for approval by that same panel in October 2003. However, in January 2004, the FDA issued a “not approvable“ letter to the company requesting additional information and also revised the guidance for the information to be included in PMAs for breast implants.

The company also will launch a direct-to-consumer advertising campaign for the Lap-Band system, as well as continue to seek a national coverage decision for the product from the Centers for Medicare & Medicaid Services (Baltimore).

The band is inflatable and connected to an access port placed close to the skin that allows surgeons to adjust the system to meet individual patient needs. The procedure is reversible and does not require cutting or stapling of the stomach, or gastrointestinal re-routing to bypass normal digestion. Patient benefits include reduced surgical trauma, complications, pain and scarring and shorter hospitalization and recovery time compared to more invasive obesity surgeries.

Looking at specific franchises, Teti said that Inamed really likes the potential for the obesity market, particularly in the U.S. “There are six million people in the U.S. who are already morbidly obese; if you add co-morbidities to that you're in the 10-plus million number [of patients]. This is a major growth driver and will be a major factor to our business over the next several years.“

The company also is investigating the use of an endoscopically delivered saline-filled sphere for temporary weight loss. The sphere is placed in the stomach, where it remains from four to six months causing a sensation of fullness. The device is then removed endoscopically.

President and CEO Robert Byrnes made the presentation for Thermage, a promising company that is developing aesthetic devices deploying radio frequency (RF) technologies for use in non-invasive skin tightening and contouring.

The system, called the ThermaCool, is a unique monopolar RF device. The differentiating factor between the ThermaCool system and other RF devices, Byrnes said, is a capacitive coupling electrode, one of the company's core patents. Through capacitive coupling, the company said that deep, uniform and volumetric heating is deployed to tighten and contour both the skin and underlying tissue, while concurrently applying cryogen cooling to protect the epidermis.

During the procedure, the dermal layer heats up to above 60 degrees C, which tightens the collagen underneath while the skin layer is protected by cooling. New collagen fibers are created, helping firm skin and smooth wrinkles.

“The ThermaCool system can produce results in a single treatment that laser-based systems take four or more procedures to achieve,“ Byrnes said.

He said the system includes five major components: the RF generator, a handpiece, the ThermaTip delivery device, a cooling module and consumable products

The generator produces a 6 Mhz RF signal that can be directed to targeted tissue. The generator, which costs around $40,000, is regulated by a compact, Pentium-based, on-board computer capable of rapidly processing a high volume of treatment feedback from the handpiece assembly, including temperature, treatment application force, tissue contact, and information on the RF interaction with tissue.

The handpiece contains an advanced computer logic board that processes information about skin temperature and contact, treatment force against the skin, cooling system function and other important data. A precision control valve within the handpiece meters the delivery of cryogen, which cools and protects the epidermal surface.

The ThermaTip delivery device contains the patented technology components that transform radio frequency energy into a controlled, volumetric tissue-heating source with simultaneous surface cooling.

The single-patient-use ThermaTip device is available in several configurations of firings, size and depth for efficient implementation of optimal treatment guidelines. These disposable products range in price from around $150 to $700, depending, Byrnes said, upon the application.

While the company has primarily focused on the face and neck, he said Thermage would increasingly be turning its attention to other areas of the body, including the arms, legs, knees, elbows and abdomen.

Byrnes noted that an initial public offering is being considered, expected to occur sometime during the coming year.

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