BACKGROUND
The demand for aesthetic procedures continues to grow, whether for a younger look and shapelier body, or following surgical procedures such as lumpectomy and mastectomy. Plastic surgeons are constantly looking for new products that improve outcomes while increasing their revenue stream.

Non-invasive aesthetic procedures are the fastest growing segment of the tremendous aesthetics surgery market. Procedures using injectables and soft-tissue fillers reduce the time, costs, and discomfort associated with aesthetic surgery. They are positioned to replace invasive procedures such as implants and the lengthy, expensive fat injections after liposuction that are used for soft tissue reconstruction following lumpectomy/mastectomy and as fillers for facial wasting.

Small-volume (dermal) fillers, the second largest sector within the non-invasive aesthetics market, are injected into the face and neck area to reduce wrinkling. Composed primarily of hyaluronic acid (HA) and collagen, today’s fillers last between 3 and 12 months. There is an increasing opportunity — and an unmet market need — for large-volume fillers for use in soft tissue reconstruction and augmentation procedures.

TECHNOLOGY and PRODUCT
Juvenis has developed a flexible fat-based material that provides an effective solution for soft tissue repair, fill, or augmentation. Juvenis’ unique hydrophilic-hydrophobic compound is an injectable, biodegradable liquid polymer that increases in viscosity to form a soft, natural-looking gel when injected into the tissue. It degrades into safe components that are naturally eliminated from the body. Tenergel, the company’s first line of products, addresses the tremendous unmet need for aesthetic and related reconstructive fat replacement. A breakthrough alternative to fat injections,

Tenergel’s advantages include:
• Flexible formulation for multiple applications
• High safety profile
• Simple to prepare and inject • No allergy testing required
• Long lasting: “pre-programmed” duration between 1 and 24 months
• Significantly lower production costs

As the first synthetic, fat-like injectable material Juvenis’ technology will establish its own niche in the injectable filler market. The Company is first targeting the reconstruction and augmentation sectors of the aesthetics market.

Six month preclinical trial results showed a high level of safety, excellent tolerability, and significantly longer persistence as compared to Macrolane.

MARKET SIZE
The global aesthetics market is projected to reach $8.2 billion by 2012 with the dermal filler sector continuing its double-digit growth to exceed $1 billion by 2011. Product efficacy, supplier relationships, cost, and aggressive marketing are key factors for penetrating this market. (MedTech Insight)

The first HA filler in the market for large volume use, Macrolane (QMed), has had limited market success due to its high price, limited duration (9-12 months), and problems such as granulation. Tenergel’s extended duration, ease of injection, and natural feel places it far ahead of the competition.