Healthcare Industry News: neurostimulation
News Release - October 2, 2008
NeuroMetrix Receives FDA 510(k) Clearance for UNIVERSAL(TM) Electrodes used in the Performance of Nerve Conduction StudiesWALTHAM, Mass.--(HSMN NewsFeed)--NeuroMetrix, Inc. (Nasdaq: NURO ) today announced that it has received 510(k) clearance for its UNIVERSAL Electrodes from the U.S. Food and Drug Administration (FDA). This regulatory determination by the FDA gives NeuroMetrix clearance to market the UNIVERSAL Electrodes in the U.S. These electrodes are intended to be used with the NeuroMetrix ADVANCE(TM) NCS/EMG System for performance of nerve conduction studies.
NeuroMetrix obtained regulatory clearance for three UNIVERSAL Electrodes: the UNIVERSAL Stimulator Bar Electrode for peripheral nerve stimulation, and the UNIVERSAL Tab and Ring Electrode Sets for recording of motor and sensory responses from peripheral nerves. The UNIVERSAL Electrodes are individually placed electrodes which are not configured for specific nerves or limbs. They are disposable and for single patient use.
"The UNIVERSAL Electrodes represent an important expansion of our consumables offering for physicians using ADVANCE," said Shai N. Gozani, M.D., Ph.D., NeuroMetrix's President and Chief Executive Officer. "These electrodes allow physicians to stimulate and record from essentially any peripheral nerve at both distal and proximal sites. We believe these electrodes will be used by neurologists, physical medicine and rehabilitation ("PM&R") physicians, and other specialists with peripheral nerve expertise that have adopted our ADVANCE System.”
Dr. Gozani continued, "The UNIVERSAL Electrodes build on our extensive experience developing electrodes for use in the performance of nerve conduction studies. Over 4 million of our nerve-specific electrodes have been used in the past nine years. The UNIVERSAL Electrodes incorporate several of the same technological innovations including a single keyed connector to reduce connection errors, an embedded digital thermometer to monitor skin surface temperature, flexible printed circuits for integration of electrical traces and hydrogels, and discrete packaging to prevent electrode degradation.”
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 assessment and treatment of diseases and injuries of peripheral nerves, and that provide regional anesthesia and pain control. To date, our focus has been primarily on the assessment of neuropathies. Neuropathies affect the peripheral nerves and parts of the spine and are frequently caused by or associated with carpal tunnel syndrome, diabetes, sciatica, and other clinical disorders. We market systems for the performance of nerve conduction studies and needle electromyography procedures.
Our product pipeline includes a system 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 products for intra-operative peripheral nerve assessment and monitoring, and a neurostimulation based product that promotes nerve fiber regeneration for the treatment of acute nerve injuries such as those resulting from lacerations or 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 the UNIVERSAL Electrodes; our success in marketing the UNIVERSAL Electrodes; 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.
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