Healthcare Industry News: duloxetine
News Release - April 28, 2008
NeuroMetrix Receives FDA 510(k) Clearance for the ADVANCE(TM) System for the Performance of Nerve Conduction Studies and Needle Electromyography Procedures
WALTHAM, Mass.--(HSMN NewsFeed)--NeuroMetrix, Inc. (Nasdaq: NURO ) today announced that it has received 510(k) clearance for its ADVANCE System (“ADVANCE”) from the U.S. Food and Drug Administration (FDA). This regulatory determination by the FDA gives NeuroMetrix clearance to market ADVANCE in the U.S. market. The device is intended to be used by physicians to perform nerve conduction studies and invasive electromyography procedures.ADVANCE is a comprehensive platform for the performance of traditional nerve conduction studies and invasive electromyography procedures. The technical specifications include a precision electrical stimulator and dual recording channels for acquiring nerve conduction responses. A third channel is available for recording needle electromyography signals. ADVANCE introduces several important technological improvements into the market. These include a small form factor and power from a high capacity lithium-ion battery making use of the device convenient in many environments. The amplification and digitization hardware is embedded in the cable connector thereby providing digital signal transmission from the recording electrodes to the device. This technology reduces susceptibility to electrical interference and makes the device suitable for all settings, even challenging applications such as nerve function assessment in intensive care units. The device is designed around a high-resolution color touch screen that facilitates real-time review and editing of nerve conduction waveforms. Integrated Bluetooth® provides convenient wireless communication with data management and report generation servers. This wireless link also enables expansion of system capabilities with the introduction of modules in the future. Finally, several enhancements have been made to the proprietary NeuroMetrix neurophysiological analysis software, which is resident on ADVANCE devices. We believe that this software provides physicians with accurate, reliable, and clinically useful nerve conduction parameters.
“ADVANCE builds on our extensive experience developing, manufacturing, and marketing neurophysiological technologies,” said Shai N. Gozani, M.D., Ph.D., NeuroMetrix's President and Chief Executive Officer. “Our NC-stat device has been on the market since 1999 with over 1.0 million patients tested since its introduction. The NC-stat has also been used in multiple large-scale federally funded epidemiological studies and as part of Phase I and successful Phase III drug registration trials that were reviewed by the FDA, including Lilly & Co’s duloxetine HCl (Cymbalta®). Although ADVANCE leverages our experience with the NC-stat, it is a new and distinct product platform. The primary regulatory predicate for ADVANCE is the Keypoint® device originally manufactured and marketed by Medtronic, Inc. to neurologists and physical medicine and rehabilitation (“PM&R”) physicians for the performance of traditional nerve conduction studies and invasive electromyography procedures.”
Dr. Gozani continued, “We expect to continue marketing the NC-stat in those markets for which its straightforward operation, proven accuracy and reliability, and automated reports are viewed as key product features. These include a portion of primary care physicians, industrial pre-placement and wellness programs, clinical studies and research, and certain international markets. In contrast to the NC-stat, ADVANCE is a traditional system that supports nerve conduction testing with any electrode methodology, real-time waveform review and cursor editing, invasive electromyography procedures, and traditional reports. We anticipate marketing ADVANCE to specialists, including neurologists, PM&R physicians, neurosurgeons, hand and plastic surgeons, and other specialists who intend to perform traditional nerve conduction studies and invasive electromyography procedures. We believe that the technological and clinical features of ADVANCE, its overall cost, and the exceptional customer and technical support provided by NeuroMetrix will be attractive compared to the other devices in this market segment.”
“Finally, consistent with the broad functionality supported by ADVANCE, we are in the process of expanding our consumables offerings with the addition of new lines of disposable electrodes and single use concentric electromyography needles,” concluded Dr. Gozani.
About NeuroMetrix
NeuroMetrix is a science based medical device company advancing patient care through the development and marketing of innovative medical device products that aid physicians in the diagnosis and treatment of diseases of the nervous system and neurovascular disorders, and that provide regional anesthesia and pain control. To date, our focus has been on the assessment of neuropathies and neurovascular disorders. Neuropathies affect the peripheral nerves and parts of the spine and are frequently caused by or associated with carpal tunnel syndrome, diabetes, and low back and leg pain, as well as other clinical disorders. The NC-stat System, NeuroMetrix's initial neuropathy evaluation system, has been on the market since May 1999 and is used in over 5,500 physician's offices and clinics in the United States for performance of nerve conduction studies. The ADVANCE System, recently cleared by the FDA for marketing in the U.S., is a system for the performance of traditional nerve conduction studies and invasive electromyography procedures.
Diabetic retinopathy is a common neurovascular complication of diabetes and the leading cause of blindness among working age adults. Through the acquisition of EyeTel Imaging, NeuroMetrix markets the DigiScope™, which is a retinal imaging system designed for use at the point-of-care in physician offices and vision clinics.
Our product pipeline includes the NAVIGATOR™ System, a device designed to precisely deliver pharmacologic agents such as anesthetics and corticosteroids in close proximity to nerves (“perineurally”) for regional anesthesia, pain control and the treatment of focal neuropathies such as carpal tunnel syndrome. We are also developing a neurostimulation based product that promotes nerve fiber regeneration for the treatment of acute nerve injuries such as due to lacerations and other forms of trauma.
The statements contained in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding NeuroMetrix's or its management's expectations, hopes, beliefs, intentions or strategies regarding the future. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "plan," "hope" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this press release are based on NeuroMetrix's current expectations and beliefs concerning future developments and their potential effects on it. There can be no assurance that future developments affecting NeuroMetrix will be those that NeuroMetrix has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond NeuroMetrix's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with: reimbursement by third party payers to the Company’s customers for procedures performed using ADVANCE; our success in marketing ADVANCE; the effectiveness of the Company’s or its collaborators’ products compared to other medical device products; potential future publication of articles or announcement of positions by physician associations or other organizations that are unfavorable to the Company’s or its collaborators’ products; plus factors described under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007 or described in the Company’s other public filings.
Should one or more of these risks or uncertainties materialize, or should any of NeuroMetrix's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. NeuroMetrix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Source: NeuroMetrix
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