CASMED Submits FORE-SIGHT® OEM Module 510(k) to FDA
BRANFORD, Conn. (January 24, 2018) – CAS Medical Systems, Inc. (NASDAQ: CASM) (CASMED), a leader in non-invasive cerebral oximetry patient monitoring, announces that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the FORE-SIGHT Tissue Oximetry OEM Module (“OEM Module”), an OEM version of its FORE-SIGHT ELITE® Tissue Oximeter. The OEM Module allows third-party manufacturers to incorporate CASMED’s FORE-SIGHT technology into their patient monitors as a solution for tissue and cerebral oximetry. The Company expects to receive regulatory clearance for this product in the second quarter of 2018.
The OEM Module will permit the use of FORE-SIGHT oximetry without a standalone FORE-SIGHT monitor, by incorporating the intelligence of the FORE-SIGHT system within a cable that connects a display monitor to the disposable sensors placed on the patient. This design allows tissue oximetry values derived by FORE-SIGHT technology to be displayed on a third-party monitor with minimal user-interface modifications.
“This filing is a major milestone for CASMED as we seek to make our best-in-class FORE-SIGHT oximetry technology available to manufacturers of other monitoring equipment,” said Thomas M. Patton, President and Chief Executive Officer of CASMED. “By partnering with third-party monitoring companies to incorporate FORE-SIGHT oximetry technology through the OEM Module, CASMED can leverage their selling resources to more quickly expand the market for tissue oximetry and gain market share.
“In addition, a multi-parameter monitor is often preferred by hospitals to a standalone monitor, where space in the operating theatre and the intensive care unit are at a premium. By incorporating FORE-SIGHT readings into the multi-parameter monitor, tissue oximetry values may be transmitted seamlessly into the electronic patient record. Finally, with the FORE-SIGHT values displayed on the multi-parameter monitor, it may be possible in the future to incorporate this useful measure of end-organ tissue oxygenation with predictive algorithms that might alert clinicians in advance to hypoxic distress.
“Once the OEM Module is cleared by the FDA, it creates a pathway for filing and clearance in combination with third-party monitors,” he added. “Pursuant to ongoing joint development efforts we anticipate filing for FDA clearance on our first OEM Module combination product before the end of 2018.”
About CASMED® – Monitoring What's Vital
CASMED products are designed to provide unique non-invasive monitoring solutions that are vital to patient care. The Company's FORE-SIGHT® Cerebral Oximeters provide a highly accurate, non-invasive measurement of tissue oxygenation in the brain. Direct monitoring of tissue oxygenation can provide a superior and powerful tool to alert clinicians to otherwise unrecognized and dangerously low levels of oxygen in the brain and empower them to improve patient care. For further information regarding CASMED, visit the Company's website at www.casmed.com.
Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements relating to the future performance of the Company are subject to many factors including, but not limited to, customer acceptance of the products in the market, the introduction of competitive products and product development, the impact of any product liability or other adverse litigation, working capital and availability of capital, commercialization and technological difficulties, the impact of actions and events involving key customers, vendors, lenders, competitors, and other risks detailed in the Company’s Form 10-K for the year ended December 31, 2016, and other subsequent Securities and Exchange Commission filings.
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CAS Medical Systems, Inc.
Jeffery A. Baird
Chief Financial Officer