Zynex Receives FDA 510(k) Clearance for the NexWave Medical Device
LONE TREE, Colo.–(BUSINESS WIRE)–Zynex, Inc. (OTCBB:ZYXI), a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it received FDA 510(k) clearance on its NexWave medical device.
The NexWave device is the next generation in electrotherapy treatment and will be manufactured, marketed and sold through our Zynex Medical subsidiary. This device is capable of delivering three modalities of stimulation; traditional TENS, interferential and neuromuscular electrical stimulation. The combined modalities of the NexWave provide a wide variety of pain and muscle rehabilitation therapies through one device.
Zynex’s CEO, Thomas Sandgaard, commented, “We are very excited about the market introduction of this new product. The combined modalities of our NexWave provide doctors and clinicians a more comprehensive pain therapy solution for their patients. This device was designed with the patient in mind, as it is compact and easy to use, and falls under existing medical billing codes. We believe this new product is unique in the electrotherapy industry and provides our sales force with a competitive edge to fuel revenue generation in our already rapidly growing Zynex Medical subsidiary.”
Zynex, Inc. (founded in 1996), operates under three primary business segments; Zynex Medical, Zynex NeuroDiagnostics and Zynex Monitoring Solutions. Zynex Medical engineers, manufactures, markets and sells its own design of electrotherapy medical devices for standard digital electrotherapy, used for pain relief, pain management and stroke and spinal cord injury rehabilitation. Zynex Medical’s product lines are fully developed, FDA-cleared, commercially sold, and have been developed to uphold the Company’s mission of improving the quality of life for patients suffering from impaired mobility due to stroke, spinal cord injury, or debilitating and chronic pain. Zynex NeuroDiagnostics, currently in the development stage, has been established to market EMG, EEG, sleep pattern, auditory and nerve conductivity neurological diagnosis devices through product development or acquisitions. Zynex Monitoring Solutions, currently in the development stage, has been established to develop and market medical devices for non-invasive cardiac monitoring.
For additional information please visit: http://www.ir-site.com/zynex/default.asp.
Safe Harbor Statement
Certain statements in this release are “forward-looking” and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain additional capital in order to grow our business, our ability to engage additional sales representatives, the success of such additional sales representatives, the need to obtain FDA clearance and CE marking of new products, the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement from insurance companies for products sold or rented to our customers, acceptance of our products by health insurance providers, our dependence on third party manufacturers to produce our goods on time and to our specifications, implementation of our sales strategy including a strong direct sales force, the uncertain outcome of pending material litigation and other risks described in our filings with the Securities and Exchange Commission including the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2010.
Anthony Scalese, CFO