Neuromodulation Market

Neuromodulation represents one of the most significant market opportunities in the medical device industry today. With multiple product categories growing annually at 20 to 30 percent, this dynamic market generated over $704 million in 2002 and is expected to exceed the billion-dollar mark by 2005.

The neuromodulation market is characterized by few competitors, high technology, and substantial barriers to entry. In addition, it is a sizeable and highly under-penetrated market with a target population of several million patients with approved and emerging indications. In 2000, only 60,000 procedures were performed, indicating a clear under-penetration of neuromodulation therapies.

Advances in technology, procedural techniques, consumer advocacy, and demographics are converging to accelerate the use of neuromodulation. Pain management is receiving increasingly more attention and has emerged as a national agenda item.

The U.S. market opportunity is outlined in the chart below, illustrating the potential growth for electrical stimulation and drug pump systems.

*ANS spinal cord stimulation systems are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent or as an adjunct to other modes of therapy used in multidisciplinary approach. Additionally, ANS Renew RF systems are also indicated to stimulate electrically peripheral nerves to relieve severe, intractable pain. For detailed information about these systems, refer to the appropriate device clinician’s manual.

**ANS is searching for new treatments and indications. ANS products are currently not approved for these indications.

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Statements contained in this media kit that are not based on historical facts are "forward-looking statements." Terms such as "plan," "should," "will," "may," "would," "anticipate," "believe," "intend," "estimate," "expect," "predict," "scheduled," "new market," "potential market applications" and similar expressions are intended to identify forward-looking statements that express management’s assumptions and beliefs. Such statements are by nature subject to uncertainties and risks, including but not limited to continued market acceptance of the Genesis® IPG and GenesisXP^TM IPG; competition from Medtronic, Inc., and future competitors; continued market acceptance of our Renew® system following the launches of the Genesis IPG and GenesisXP IPG; patient or physician selection of less invasive or less expensive alternatives; adverse changes in coverage or reimbursement amounts by Medicare, Medicaid, private insurers, managed care organizations or workers comp programs; intellectual property protection and potential infringement issues; obtaining necessary government approvals for new products or applications and maintaining compliance with FDA product and manufacturing requirements; product liability; reliance on single suppliers for certain components; reliance on key distributors; completion of research and development projects in an efficient and timely manner; the satisfactory completion of clinical trials and/or market tests prior to the introduction of new products; successful integration of acquired businesses, products and technologies; international trade risks; and other risks detailed from time to time in the Company’s SEC filings. Consequently, if such management assumptions prove to be incorrect or such risks or uncertainties materialize, anticipated results could differ materially from those forecast in forward-looking statements.