Healthcare Industry News: Patent Foramen Ovale
News Release - January 23, 2007
Sutura Completes Successful PFO Test of HeartStitch Suturing DeviceFOUNTAIN VALLEY, CALIFORNIA--(Healthcare Sales & Marketing Network)--Jan 23, 2007 -- Sutura, Inc. ("Sutura") (OTC BB:SUTU.OB ), an innovative developer of minimally invasive vascular suturing devices, announced today it has successfully completed a PFO Test of its HeartStitch(TM) suturing device. During the test, Sutura successfully closed the PFO (Patent Foramen Ovale) in a porcine model. The test was conducted by two of Sutura's senior medical advisors Dr. Carlos Ruiz and Dr. John Crew, who successfully placed the new HeartStitch device through the PFO and sutured it closed.
"The HeartStitch is an elegant suture-based device that closes the PFO by placing only suture material, unlike the other technologies in the market. The future of the PFO market should be technologies that close the PFO and do not leave a device behind," commented Dr. Ruiz following the successful test of the HeartStitch.
The innovative HeartStitch suturing device is designed for use in the closing procedure during transcatheter management of Patent Foramen Ovale (PFO). A Patent Foramen Ovale (PFO) is a remnant window from the fetal stage in the septum (wall) between the two upper chambers of the heart. Specifically, the defect is an incomplete closure of the atrial septum that results in the creation of a flap or a valve-like opening in the atrial septal wall. A PFO is frequently found in normal healthy individuals (about 20% of adults) which is not sealed shut and is the most common cause of stroke in young people under the age of 50.
"The successful test of our HeartStitch device in suturing the PFO is the result of several years of research, development and collaboration to develop a device that can provide a surgical suture for the PFO in a minimally invasive transcatheter approach," said Anthony Nobles Sutura's Chairman and Chief Scientific Officer.
Commenting on the announcement, David Teckman, President and Chief Executive Officer at Sutura, Inc, stated, "Sutura is dedicated to the development and commercialization of its HeartStitch(TM) suturing devices. This successful PFO test speaks to the experience and depth of Sutura's Clinical Advisory Team, and the Company's ability to carry that out. Dr. Ruiz has pioneered several new interventions, and has 11 U.S. patents of his own on different cardiovascular devices and brings extensive knowledge of the PFO (Patent Foramen Ovale) and ASD (Atrial Septal Defect) fields to our HeartStitch(TM) project."
About Sutura, Inc.
Sutura®, Inc. (www.suturaus.com) is a medical device company that has developed a line of innovative, minimally invasive, vascular suturing devices to suture the puncture created in arteries during open surgery and catheter-based procedures. The Company's line of SuperStitch medical devices provide sutured closure of the arteriotomy site utilizing the existing catheter sheath introducer or cannula during fluoroscopically guided procedures and directly through the open arteriotomy during open surgical procedures.
Within the United States the 8F & 6F SuperStitch devices are available for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind closure of an arteriotomy site. The SuperStitch 8F & 6F is approved in the European Union and CE marked with the indication for use as follows: The SuperStitch is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. In the EU there is no requirement for the use of fluoroscopic guidance. Sutura's headquarters are in Fountain Valley, California. "Sutura®" and "SuperStitch®" are registered trademarks of Sutura, Inc.
Forward-Looking Information Is Subject to Risk and Uncertainty
Certain statements in this press release may contain projections or "forward-looking" information (as defined in the Private Securities Litigation Reform Act of 1995) that involve risk and uncertainty. The words "aim", "plan", "likely", "believe", "expect", "anticipate", "intend", "estimate", "will", "should", "could", "may", "appears", and other expressions that indicate future events and trends identify forward-looking statements. These statements are not guaranties of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are based upon assumptions as to future events that may not prove to be accurate. Actual outcomes and results may differ materially from what we express or forecast in these forward-looking statements. As a result, these statements speak only as of the date they were made and we undertake no obligation to publicly update or revise any forward-looking statements. Our actual results and future trends may differ materially from our forward-looking statements depending on a variety of factors including the ability of the company to raise additional funds necessary for the continued operation of the company, acceptance of the SuperStitch® devices by medical providers and the marketplace in general and the success of the proposed sales and marketing plan , the ability of the company to establish a successful distribution relationship with a strategic partner, the continued growth of the vessel closure marketplace and the company's ability to continue to expand and protect its technology patents.
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