Products and procedures for cosmetic enhancement have gained wide acceptance in recent years. Thus, the market for products to turn back the signs of aging is vast and growing. There were over 9,200,000 cosmetic surgical procedures in the US in 2004, a 450% increase since 1997, sustaining a $12.5 billion industry, growing overall by at least 10% per year. Less invasive procedures are faster growing than invasive procedures, as patients want acceptable outcomes with less down time. Market growth is also derived from many regions outside the US where the growth rate in cosmetic surgery is even greater than domestically. And men now constitute 11% of the cosmetic surgery market, a percentage that is growing.

Since cosmetic procedures are a consumer choice rather than disease treatment, they are paid for directly by the patient. The supply of physicians who perform cosmetic procedures is increasing rapidly, to some extent as a hedge against the growing income constraints of treatment requiring insurance reimbursement. And as technologies become less invasive and less training is required, physicians are willing to step outside their core specialty to perform cosmetic procedures. Whereas twenty years ago the vast majority of cosmetic procedures were performed by plastic surgeons, nowadays they are offered by dermatologists, general surgeons, internists, gynecologists, dentists, podiatrists, etc. The company estimates that there are over 10,000 physicians who could constitute users of its products.

As we age, environmental factors, such as sun damage, combine with atrophy of soft tissue to deny us our youthful appearance. Skin sags, cheeks hollow, lips thin, and folds become increasingly visible. A plethora of options are available, some more effective than others. For surface rejuvenation (fine lines, pitting, spots, etc.), treatments include topical creams, skin peels and abrasion, energy delivery by means of light, laser, radiofrequency or ultrasound, or a combination. All of these therapies must be repeated at intervals to achieve lasting effect.

Botulinum toxin acts to straighten wrinkles by temporarily paralyzing, or softening, the surrounding muscles, especially in the forehead and around the eyes. While often confused with injected dermal fillers, Botox™ does not add volume, and is not used for plumping lips, filling deep folds, augmenting cheeks, etc.

Replacing lost volume is an essential element of facial rejuvenation. The ideal tissue filler would be one that is biocompatible, minimally invasive, predictable, adaptable to the anatomy of a given patient, long-lasting, reversible, natural-appearing, requiring only a brief procedure for placement, and cost effective. EVERA’s technology was designed with this ideal in mind.

Both solid and injectable materials, either natural or synthetic, have been used to augment volume, but all approaches have limitations. Fat may be sucked from the leg and injected into the face or lips. Known as lipo-filling, this has unpredictable longevity and the results are highly dependent on the skill of the surgeon.

The use of injectable dermal fillers has expanded greatly in recent years owing to their perceived ease of administration and relative safety. Temporary injectable compounds include those made of collagen or hyaluronic acid. Since these chemicals are degraded by the body, the cosmetic effect begins to fade soon after treatment and is typically gone altogether after 3 to 6 months in mobile areas such as the lips. The patient then must bear the cost and inconvenience of repeated treatments, or simply abandon the notion of enduring enhancement.

Permanent or long-lasting injectable dermal fillers generally consist of small particles in a gel carrier. They cannot be removed and can be associated with significant complications, such as unsightly and difficult-to-treat lumps and nodules. Most are contraindicated for use in the lips because of potential complications. Liquid silicone has been used as a permanent filler but has been associated with severe complications and is contraindicated for use in cosmetic enhancement.

Solid silicone implants are poorly suited for mobile, soft areas such as the lips because the tissue does not attach to them and they can fold and shift. Solid silicone is harder and more easily felt than the EVERA implant composed mostly of water (saline). Other solid implants made of materials such as Gore-Tex used in the lips can become stiff, inhibiting facial movement and producing a wooden, artificial appearance.

EVERA’s goal was to create a line of augmentation devices that match the viscoelastic properties of the tissue into which they are placed. By remaining soft and compliant, EVERA’s facial implants move in concert with tissue during facial animation, speech, etc., making for superior cosmetic enhancement while minimizing complications such as erosion, migration, and infection that occur when an implant moves around relative to the tissue into which it is implanted.

The ideal tissue filler would be saline, since it occupies over 90% of tissue volume. Of course, saline injected into tissue rapidly diffuses away. EVERA has developed a very thin, multi-layer polymeric balloon to retain saline in a given location, such as the lips. The outer micro-porous membrane heals with gentle tissue incorporation without a thick capsule. Novel construction methods result in a glide plane that separates the layers, enhancing mechanical compliance. EVERA’s facial products are biocompatible and permanent. However, they can be removed at any time, if the patient desires a different look.

In addition to its products currently on the market for facial enhancement, EVERA will extend its product line by leveraging its novel technology into areas such as mammary implants and augmentation materials for urogynecologic surgery, among others.