CAS Medical Systems, Inc. Wins FDA Approval for FORE-SIGHT ELITE in Pediatric and Neonatal Patients

CASMED Receives FDA Approval for FORE-SIGHT ELITE in Pediatric and Neonatal Patients

Company Sponsors Symposium at Society of Cardiac Anesthesiology Conference

BRANFORD, Conn., April 15, 2015 (GLOBE NEWSWIRE) -- CAS Medical Systems, Inc. (CASM) (CASMED), a leader in medical devices for non-invasive patient monitoring, announces receipt of an expanded label for its FORE-SIGHT(R) ELITE oximeters from the U.S. Food and Drug Administration (FDA) to include its new medium and small sensors for use with pediatric and neonatal patients.

“The approval of the FORE-SIGHT ELITE in this patient population came somewhat earlier than we had expected, and allows us to complete our product offering while opening new opportunities both in the U.S. and around the world,” said Thomas M. Patton, President and Chief Executive Officer of CASMED. “With the launch of the FORE-SIGHT ELITE for pediatric and neonatal patients, we will have the ability to address additional sales channels and call points within a hospital with the exact same monitor. We are on track to introduce the FORE-SIGHT ELITE in this market segment in the late third or early fourth quarter of this year.

“We based our regulatory filing on a significant number of clinical evaluations of pediatric patients conducted at multiple sites around the world, including some of the nation’s leading children’s hospitals. Feedback on the performance of the FORE-SIGHT ELITE from these sites was overwhelmingly positive,” added Mr. Patton.

CASMED also announces that it sponsored a lunch symposium at the 37^th Society for Cardiac Anesthesia Annual Meeting & Workshops held earlier this week in Washington, D.C. The hour-long symposium featured a panel of leading physicians discussing the clinical benefits of monitoring cerebral oxygenation in a broad variety of cardiac surgeries through the use of case studies, personal experience and the latest clinical evidence.

“We are delighted that more than 200 cardiac anesthesiologists joined us for this standing-room-only discussion,” added Mr. Patton. “Cerebral oxygenation is a major concern during cardiac surgery, and we were able to showcase the patient benefits of monitoring with our FORE-SIGHT ELITE oximetry to anesthesiologists who are the target customers for our product.”

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^(R) Absolute Cerebral Oximeter provides a 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 more 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, 2014, 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.

jobspost your resume

Help employers find you! Check out all the and .