Advanced Neuromodulation Systems Receives Investigational Device Exemption Approval From the FDA for Clinical Trials of Its Constant Flow Implantable Pump.

Business Editors & Health Writers

DALLAS--(BUSINESS WIRE)--Jan. 17, 2001

U.S. Clinical Trials Set to Begin in First Quarter of 2001;

CE Mark Approval Also Received;

Initial European Implants Expected in First Quarter of 2001

Advanced Neuromodulation Systems Inc. (ANS) (Nasdaq:ANSI) today announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to initiate clinical trials of its proprietary AccuRx(TM) Constant Flow Implantable Pump, which is designed to treat chronic, intractable pain of malignant or nonmalignant origin using intrathecal or epidural infusion of preservative-free morphine.

ANS said that the FDA approved the clinical study of 109 patients at 12 sites in the United States. The company said that AccuRx implants are expected to begin in the first quarter of 2001. The clinical study is designed to gather safety and reliability data to support a Premarket Approval (PMA) application for ANS' AccuRx device.

Chris Chavez, chief executive officer of ANS, said: "Implantable pump therapy blocks chronic pain messages from reaching the brain, and typically is prescribed with very small dosages of medication. As a result, this therapy is reported to cause far fewer adverse side- effects than systemic morphine."

ANS also announced that it has received CE Mark approval for its AccuRx Pump to treat chronic, intractable pain of malignant or nonmalignant origin using intrathecal or epidural infusion of preservative-free morphine.

The CE Mark is the symbol used to indicate that a particular product complies with relevant European regulatory requirements and has achieved a satisfactory level of safety, and thus may be marketed freely throughout the European Community. ANS is preparing for initial patient implants of its AccuRx pump in Europe during the first quarter of 2001.

Chavez added: "Sales of implantable drug pumps and related products, including both constant flow and programmable pumps, are estimated to exceed $225 million worldwide and are growing rapidly. The approval of our IDE by the FDA and the receipt of CE Mark approval for our first product in this area are important milestones for ANS as we position the company to participate in this exciting growth opportunity."

ANS recently announced that it has received CE Mark approval for its Genesis(TM) Totally Implantable Pulse Generator (IPG) Spinal Cord Stimulator for treatment of chronic pain of the trunk and limbs, and that it has completed initial patient implants of its IPG in Europe.

About Advanced Neuromodulation Systems

Advanced Neuromodulation Systems designs, develops, manufactures and markets implantable systems used to manage chronic intractable pain and other disorders of the central nervous system.

The following is a "safe harbor" statement under the Private Securities Litigation Reform Act of 1995: Statements contained in this document that are not based on historical facts are "forward-looking statements." Terms such as "plan," "should," "would," "anticipate," "believe," "intend," "estimate," "expect," "predict," "scheduled," "new market," "potential market applications" and similar expressions are intended to identify forward-looking statements. Such statements are by nature subject to uncertainties and risks, including but not limited to: completion of research and development projects in an efficient and timely manner; obtaining regulatory approvals on a timely and cost-efficient basis to permit the introduction of new products; the successful reclassification of the IPG by the FDA; the satisfactory completion of clinical trials and/or market tests prior to the introduction of new products; the adequacy, acceptability and timeliness of component supply; the approval of new products by reimbursement agencies like insurance companies, HMOs, Medicare and Medicaid; the efficacy of the company's products for new applications; and other risks detailed from time to time in the company's Securities and Exchange Commission 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.