BRANFORD, Conn., Sept. 7 /PRNewswire-FirstCall/ -- CAS Medical Systems, Inc. (Nasdaq: CASM - News) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its FORE-SIGHT Absolute Cerebral Oximeter in additional patient populations including children over 40 kg and infants.
CAS Medical Systems received FDA 510(k) clearance to market its cerebral oximeter for use with adult patients in December of 2005. The Company plans to launch the FORE-SIGHT Adult Cerebral Oximeter later this year.
“Cerebral oximetry enhances safety for patients of all ages, and in a variety of clinical settings,” commented Louis P. Scheps, President and CEO of CAS Medical Systems, Inc. “This is a clear example of our ability to leverage our core technology and expand the market opportunity of FORE-SIGHT for use in supplemental patient populations beyond adults. We are enthusiastic about the progress of our research and development program to date, and continue to remain focused on the launch of FORE-SIGHT later this year.”
About the FORE-SIGHT Cerebral Oximeter
Our initial market focus is on high risk cardiovascular surgeries, of which there are about 700,000 performed each year in the U.S. Additional market opportunities include a broad range of general surgical procedures and postoperative and critical care settings. Protecting the brain from low oxygen levels during these procedures is an important goal of every surgical team because the brain is highly vulnerable to oxygen deprivation. At normal body temperatures, damage to brain cells due to lack of oxygen can occur after just a few seconds. The FORE-SIGHT Cerebral Oximeter provides new information that allows clinicians to monitor and respond to instances of brain tissue oxygen deprivation before damage to the brain occurs.
About CAS Medical Systems, Inc. -- CASMED(TM)
Founded in 1984, CAS Medical Systems, Inc. is dedicated to the design and manufacture of innovative technologies and products vital to patient care in the most challenging clinical environments. Its current product lines include blood pressure measurement technology, vital signs monitoring equipment, blood pressure cuffs, apnea monitoring equipment and products for neonatal intensive care. With a reputation for the highest quality products available in the markets it serves, CASMED products are used by clinicians worldwide.
For more information contact:
CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 (203) 488-6056 ir@casmed.com
Investors Media Financial Dynamics Financial Dynamics John Capodanno Robert Stanislaro 212-850-5705 212-850-5657 jcapodanno@fd-us.com rstanislaro@fd-us.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 financial 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, commercialization and technological difficulties, and other risks detailed in the Company’s 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.
Source: CAS Medical Systems, Inc.
