Market

The number of individuals afflicted with tinnitus in North America exceeds 50 million. In the U.S., more than 13 million of these seek medical treatment. Silere’s target market is the 2.7 million patients with symptoms that are highly debilitating and which severely affect their ability to function. This reflects a large unmet clinical need, representing 1% of the population. Based on human data the potential benefits of electrical stimulation for the treatment of tinnitus indicates that between 50 and 60% of severely afflicted subjects would gain relief. A product that treats this population has the potential to benefit between one million and 1.62 million patients. Silere estimates that demand for its products could reach 70,000 units per year in the fifth year of commercial distribution. This corresponds to annual sales of $400 million per year.

Customers

The American Neuro-Otology Society (ANS) has 700 members, all of whom are qualified as Silere’s customer group. Anecdotal discussions and clinical record reviews with practicing neuro-otologists indicate that 10 to 20 patients a week report tinnitus as their main complaint.

Products

The technology used to build Silere’s proposed products is equivalent to the technology used to design and build a cochlear implant. The product architecture is conceived and defined to allow the use of software to modify, upgrade and expand the clinical benefits of Silere’s technology and stimulation paradigms. It is Silere’s intent to develop and sell software products that can increase the therapeutic utility of its systems as tinnitus treatment experience and knowledge is developed and refined.

Regulatory Strategy

The clinical effectiveness and safety of Silere technology will be demonstrated with an initial single site U.S. “mini trial” that will enroll five subjects. Following the mini trial, Silere will sponsor a two center clinical trial in Europe, with the objective of obtaining regulatory approval and CE Mark. Marketing and sales will commence in the European Union following CE Mark approval to gain revenue and reduce burn rate.

Silere will conduct a two center United States feasibility study, followed by a multi-center pivotal trial, concurrent with the CE Mark application in Europe. The clinical work in the U.S. will require an Investigational Device Exemption (IDE), and will support a request for Pre Market Authorization (PMA).

Each of these clinical and regulatory events is scheduled as key activities of the business development. It is expected that the clinicians who participate in these trials will become the initial customers for Silere’s products. We anticipate that these clinicians will publish and report on their experiences with this technology at various conferences and in publications in respected, peer-reviewed journals. Additionally, Silere plans to sponsor meetings and presentations describing the products, technology and clinical benefits using selected participants from the original clinical trials as speakers.

As Silere develops, it intends to continue sponsoring clinical research and to solicit various clinical experts to participate in these projects and present their results. The use of advisory boards whose members are recognized for their expertise will provide additional sources of input and counseling to Silere’s potential new customers.