CASMED Receives FDA Approval for FORE-SIGHT ELITE in Non-Cerebral Tissue
BRANFORD, Conn., May 7, 2014 (GLOBE NEWSWIRE) -- CAS Medical Systems, Inc. (CASM) (CASMED), a leader in medical devices for non-invasive patient monitoring, today announced receipt of U.S. Food and Drug Administration (FDA) clearance of an expanded label claim for the Company’s FORE-SIGHT ELITE(R) Oximeters for use in non-cerebral tissue of adults. This clearance will permit FORE-SIGHT ELITE oximeters to be marketed to clinicians to determine oxygen saturation of hemoglobin in musculoskeletal applications, and follows CASMED’s submission of a 510(k) application.
“We are delighted to receive this expanded indication, which shows our Company’s commitment to continually expand and upgrade the quality and application of FORE-SIGHT(R) for our customers,” said Tom Patton, CASMED’s President and CEO. “While this new application represents a modest incremental market opportunity, it may help to increase utilization as clinicians who monitor skeletal muscles also tend to monitor both hemispheres of the brain at the same time. Our new FORE-SIGHT ELITE monitor is designed to report up to four channels of oxygenation from four sensors simultaneously in an easy-to-use touchscreen interface.”
CASMED plans to introduce the upgraded software that perfects these non-cerebral applications for the FORE-SIGHT ELITE in the third quarter ending September 30, 2014.
About CASMED(R) -- Monitoring What’s Vital
CASMED is a leading developer and manufacturer of medical devices for non-invasive patient monitoring. The Company’s FORE-SIGHT Absolute Cerebral Oximetry technology provides highly accurate, non-invasive, continuous measurement of absolute cerebral tissue oxygen saturation. Direct monitoring of tissue oxygenation provides a superior and powerful tool to alert clinicians to otherwise unrecognized and dangerously low levels of oxygenation of the brain and other tissues, thereby allowing them to intervene appropriately in the care of their patients. In addition to FORE-SIGHT Oximeters and accessories, the Company provides a line of bedside patient vital signs monitoring products, proprietary non-invasive blood pressure monitoring solutions for OEM use, neonatal intensive care supplies, and service. CASMED products are designed to provide unique monitoring solutions that are vital to 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, the 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, 2013, and other subsequent Securities and Exchange Commission filings.
Such statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. When used in this press release, the terms “anticipate”, “believe”, “estimate”, “expect”, “may”, “objective”, “plan”, “possible”, “potential”, “project”, “will”, and similar expressions identify forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and we do not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information, or otherwise.
Contact:
Company Contact
CAS Medical Systems, Inc.
Jeffery A. Baird
Chief Financial Officer
(203) 315-6303
ir@casmed.com
Investor Contact
LHA
Bruce Voss (bvoss@lhai.com)
(310) 691-7100
@LHA_IR_PR
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