Zynex Submits Pre-Submission Application to the FDA for Its Non-Invasive Blood Volume Monitor
Lone Tree, Colorado (PRWEB) March 05, 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 that it has submitted a Pre-Submission application to the FDA for its non-invasive Blood Volume Monitor, CM-1500. Zynex believes that this will be the first device to provide an indication of fluid balance and blood loss in the operating room or potential post-surgical internal bleeding in recovery.
Because there is no predicate device for the Blood Volume Monitor, Zynex has filed a Pre-Submission application with the FDA in order to enable the device to go through the newly created De Novo process.
During blood loss the human body compensates for the “stress” by exerting several separate physiological reactions. These reactions include increased heart rate, the body becoming cold and “clammy,” and/or movement of blood from extremities toward the central organs around the thorax, torso and the head.
The blood volume monitor is designed to detect changes in blood volume as small as 200ml and displays the changes in the form of an Index graph. The device has a large LCD touch-screen similar to ECG monitors currently used in hospitals. The device measures up to six parameters using surface electrodes and a pulse oximetry waveform, with all placements of electrodes on the arm. The device is easy to use as it self-adjusts to most known situations and potential artifacts.
Thomas Sandgaard, Zynex CEO stated: “We expect the FDA to classify our Blood Volume Monitor as a Class II device due to its non-invasive nature and we are prepared to work through the newly created De Novo approval process created for unique new technologies such as this. We expect to hear back from the FDA in less than 90 days regarding their answers and recommendations for the De Novo process.”
Sandgaard continued: “I am very excited about now having a dialog with the FDA about this revolutionary product after more than four years of R&D and testing. We are still waiting for decisions on our US and European patent applications. The Blood Volume Monitor will serve a tremendous unmet need in the hospital sector today where patients suffer from complications and, at times, death as a result of undetected or incorrectly estimated blood loss or internal bleedings.”
About Zynex
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.ir-site.com/zynex.
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, 2013.
Contact: Zynex, Inc. 303-703-4906
Brian Alleman, Zynex, Inc., +1 (303) 703-4906 Ext: 3322, [email protected]
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