LONE TREE, Colo (PRWEB) June 12, 2015
Zynex, Inc. (OTCQB: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, neurological diagnostics, and compound pharmacy, announced today it has received a response from the FDA concerning the basis for filing its application for approval of its new Blood Volume Monitor. As such, the Company has begun to prepare its request for approval pursuant to Section 510(k) of the Food, Drug and Cosmetic Act.
Thomas Sandgaard, Zynex CEO stated: “We are pleased that we can now start the process of obtaining FDA clearance for this innovative new device. We continue to test the device on blood donors and are completing the build of initial units for distribution to hospitals and surgery centers for testing in surgical environments.”
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.