510(K) Application Filed For CM1500 with the Food and Drug Administration
LONE TREE, CO / CRWEPRESSRELEASE / September 23, 2015 / Zynex, Inc. (OTCMKTS:ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac and neurological diagnostics, and compound pharmacy, announced today that its wholly-owned subsidiary, Zynex Monitoring Solutions Inc., has filed an application with the Food and Drug Administration pursuant to Section 510(k) of the Food, Drug and Cosmetic Act for clearance of its new CM1500 monitoring device. The CM1500 is capable of monitoring a patient’s fluid levels, including blood loss, during surgery and in recovery.
Thomas Sandgaard, Zynex CEO, stated: “We are excited to have reached the point of applying for FDA clearance for our revolutionary device that will enable surgical personnel to non-invasively monitor blood loss in real time. We have begun placing initial production units in hospitals for field testing and validation.” Sandgaard went on to say, “Undetected blood loss continues to be a significant risk during surgery and recovery, and current approaches are either too invasive or lacking precision and early predictive capability for blood loss and intervention. The CM1500 will reduce the risk of blood loss going undetected.”
Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation; and the company’s proprietary NeuroMove device designed to help recovery of stroke and spinal cord injury patients. Zynex’s product lines are fully developed, FDA-cleared and commercially sold world-wide. Zynex also operates a non-sterile compound pharmacy providing topical and transdermal pain creams. Zynex is also developing a new blood volume monitor for use in hospitals and surgery centers. For additional information, please visit: http://www.zynex.com.
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 or augment our liquidity in order to continue our business, the success of our compound pharmacy and international expansion efforts, 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, 2014.
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SOURCE: Zynex, Inc.