NeuroMetrix Completes CE Technical File and Achieves CE Marking for Its ADVANCE(TM) System Allowing Marketing in the European Union
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that it has completed the CE technical file for its ADVANCE System (“ADVANCE”). With this regulatory step, NeuroMetrix intends to begin marketing ADVANCE to neurologists, clinical neurophysiologists, hand surgeons, and other specialists in the EU.
ADVANCE is a comprehensive platform for the performance of traditional nerve conduction studies and needle 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. These include a small enclosure 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(R) 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. This software provides physicians with accurate, reliable, and clinically useful nerve conduction parameters.
“Now that we have the CE mark for ADVANCE, we look forward to marketing this innovative product into the United Kingdom in the third quarter, and more broadly by the end of the year through additional European distribution partners. Although our success in marketing ADVANCE in the EU will depend on many different factors, we believe that it is well suited to international markets and look forward to increasing our presence outside the US,” said Shai N. Gozani, M.D., Ph.D., NeuroMetrix’s President and Chief Executive Officer.
NeuroMetrix has ISO 13485:2003 registration and is CE certified by TUV SUD.
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, and sciatica, as well as other clinical disorders. The ADVANCE System is a comprehensive platform for the performance of traditional 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.
Diabetic retinopathy is a common neurovascular complication of diabetes and the leading cause of blindness among working age adults. NeuroMetrix also markets the DigiScope(TM), which is a retinal imaging system designed for use at the point-of-care in physician offices and vision clinics.
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 the Company’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 the Company’s current expectations and beliefs concerning future developments and their potential effects on it. There can be no assurance that future developments affecting the Company will be those that the Company has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’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: the Company’s ability to successfully market ADVANCE in the EU; reimbursement by third party payers to the Company’s customers for procedures performed using ADVANCE; the Company’s reliance on third-party distributors; compliance with international regulatory standards; effectiveness of the Company’s products compared to other medical device products; protection of the Company’s intellectual property and other proprietary rights; conflicts with the intellectual property of third parties; competition; dependence upon computer and communication infrastructure utilized by the Company’s products; potential future publication of articles or announcement of positions by physician associations or other organizations that are unfavorable to the Company’s products; other international business risks, including risks related to changes in foreign currency exchange rates, instability in political or economic conditions, potential problems related to international shipping and distribution, the potential impact of any trade protection measures and difficulties associated with foreign legal and regulatory systems; and the risks described in the Company’s filings with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. The Company 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.