Market and Need
Soft tissue augmentation (dermal filling) is achieved by injectable dermal fillers which are the largest and fastest growing segment in the aesthetic market. There are two main technologies that are currently in use for soft tissue augmentation:
Using Synthetic dermal fillers such as hyaluronic acid, collagen-based products and silicone
Using Natural dermal filers such as autologous fat (the own body fat)
The first technology is the most frequently used and is considered to be safe and available, however this technology still has a little success mostly due to its high cost, limited life span, lack of permanency and sometimes serious safety concerns. Contrarily, autologous fat grafting is fast growing and increasingly used in both aesthetic and reconstructive procedures. This method is considered to be safe, reliable, minimally invasive and affordable. The major challenge of this technology is the high resorption rate of the grafted autologous fa which ranges between 25%-80%, therefore, requesting treatments' recurrences for achieving optimal results. This problem is the "Achilles heel" of this method, thus, preventing autologous fat grafting from being popular for soft tissue augmentation in the aesthetic and reconstructive surgery market.
Product / Services
Sebana's technology is an innovative formulation containing an approved drug as active pharmaceutical ingredient. Sebana's product has the potential to enhance fat acceptance and the fat grafting method for aesthetic appearance such as tissue reconstruction due to Romberg's disease or congenital malformation (orphan conditions), breast reconstruction due to lumpectomy or mastectomy, wrinkle removal and breast augmentation for aesthetic appearance. Sebana's patented technology can revolutionize autologous fat filling in the reconstructive surgery field.
Sebana’s target market is the fast-growing aesthetic market. According to a survey published by the International Society of Aesthetic Plastic Surgery (ISAPS), over 20 million cosmetic surgical and nonsurgical procedures were performed worldwide in 2014. Fat grafting is one of the most frequently performed treatments with almost 1 million procedures annually. The use of synthetic fillers is estimated at more than 3 million procedures and is the second most popular non-surgical aesthetic treatment performed annually. Sebana's technology will potentially be used and accepted for fat grafting procedures due to its safety and expected efficacy. Therefore, a shift may be forecasted from synthetic dermal fillers to fat grafting with Sebana's technology.
Sebana's potential customers are the plastic surgeons and hospitals depending on the procedure's nature. Plastic surgeons will promote the use of Sebana's products due to their preference for autologous fat grafting over synthetic dermal fillers and they will obtain the products directly from selected distributors for aesthetic procedures. While for medical indications such like Romberg's syndrome will require hospitals to purchase the reimbursed products as part of the medical procedures.
Sales / Marketing Strategy
Sebana plans to develop a product either for preventing fat reabsorption after fat filling for the wrinkle removal indication, or after fat filling as an orphan drug for Romberg's syndrome indication (an orphan condition that uses only fat as a filler for reconstructive dermal filling). Either indications are potential and the development pathway of the product is simple and affordable for both. Currently, Sebana targets the wrinkle removal indication for its market potential and ease of development. Sebana plans its first product launch in 4 years and identifies plastic surgeons and hospitals performing reconstructive procedures as its target customers. Its geographical area focus will include USA, Europe, China and Brazil. These areas, have the highest number of plastic surgery procedures and surgeons. The leading countries in aesthetic procedures are the US, Brazil, China, India, Mexico and Japan, and collectively, their combined market reaches 55% of the global market. Combined with fat a natural dermal filler, Sebana's product may compete aggressively with the currently used synthetic dermal fillers.
The company aims to finalize development and fine tuning of its product. The product manufacturing under GMP conditions for clinical trials is estimated to be achieved within 1.5 years. Due to the safety profile of Sebana's product, the company estimates that the FDA will accept the company's stance and will approve an advanced phase (phase II/III) clinical trial in at least five centers that will take no longer than 24 months
To the best of our knowledge, currently, there are no direct competitors to Sebana's technology. Today, no products that prevents fat reabsorption after fat grafting procedures in the aesthetic market exist. There are many indirect competitors including manufacturers of synthetic dermal fillers. Actually, Sebana's technology will trigger aggressive competition among manufacturers of synthetic dermal fillers such as: Allergen (Juvederm), Galderma (Perlan; Rastylane) and Merz (Radiesse; Sculptra).
The potential customers of Sebana's products will be the plastic surgeons. Remarkably, plastic surgeons will stimulate our technology in the aesthetic market, because using fat filling for soft tissue augmentation is their preferred method and they will be the only providers of care to use this method. Having said this, by proving the effectiveness of Sebana's technology, plastic surgeons will push toward using fat filling instead of Hyaluronic acid [a synthetic filler that is currently used by all types of doctors who do soft tissue augmentation]. In addition, the use of fat filling is not complex, it is a very easy method, thus Sebana's technology will significantly increase soft tissue augmentation procedures number. According to "Income Generator"; and article that was published by Dr. Ron Shippert in 2006, the profits from fat filling procedures to plastic surgeons over Hyaluronic acid is very high thus predicting positive direct influence of Sebana's technology on plastic surgeons. To this end, we expect that all plastic surgeons will use Sebana's products to increase their income. Indeed, we expect Sebana's product will play a game changer in this huge market.
Sebana can introduce for the first time ever in the aesthetic market, a product indicated for preventing fat reabsorption after fat grafting. With Sebana's technology, autologous fat grafting will potentially become more efficient and safe with less side- effects compared to synthetic dermal fillers.
Sebana has incorporated the concepts of regulatory approval from narrow to wider indications. The company focuses on the finalization of phase II clinical trials of its first product for the wrinkle removal indication to either partner with big pharmaceuticals through a milestone M&A deal or go public for the commercialization of its technology and products. Out-licensing of Sebana technology to big pharmaceuticals or regionally is another potential option.
The expected revenues from Sebana's product sales for soft tissue augmentation using fat filling
According to mean upfront values to similar companies to Sebana Medical. The expected down payment from Sebana's technology out-licensing following a deal with milestones with a big pharmaceutical can be very attractive as it is described in the figure here below.
Analysis of mean upfront fee value for 66 companies by stage of drug development by biopharmaceutical companies developing drugs for potential markets between 2008-09.