MILFORD, Mass., Oct. 31, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that its new product, RenalGuard®, will be featured during Chronic Kidney Disease and Contrast Nephropathy, a 90 minute discussion session at Transcatheter Cardiovascular Therapeutics (TCT) 2011, November 7-11, 2011 in San Francisco, California.
As part of its participation in this important conference, PLC will demonstrate RenalGuard in its booth (#500) and RenalGuard will also be displayed in the ACIST Medical Systems booth (#1516). ACIST Medical Systems, a Bracco Group company, recently signed an agreement with PLC to distribute the RenalGuard System™ in France and in Germany.
During TCT, PLC will also host a meeting with investors on Wednesday, November 9th, from 8:30 – 10 am (PT), in the Cathedral Hill Room at the Intercontinental Hotel.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We continue to see an increased focus worldwide on the issue of contrast-induced nephropathy. The development of CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function, and clinical data continues to show that the use of RenalGuard and its associated therapy can reduce the incidence of this condition in at-risk patients. The discussion of this topic at TCT will bring to light the various prevention options available to clinicians and the benefits of RenalGuard versus today's standard of care."
Mr. Tauscher continued, "This year's TCT expects to attract a large international audience which will provide us with increased exposure in countries where we are currently selling RenalGuard, including France and Germany where we are distributing RenalGuard through our new partner, ACIST Medical Systems. Current projections indicate that more than 60% of this year's attendees will come from countries where RenalGuard is currently available through our network of distributors."
Chronic Kidney Disease and Contrast Nephropathy is a 90 minute discussion of prevention techniques and therapies including RenalGuard and its associated matched fluid replacement therapy, and will include one of the principal investigators of the MYTHOS trial, Dr. Antonio Bartorelli, and the principal investigator of the REMEDIAL II trial, Dr. Carlo Briguori. Both trials demonstrated that patients treated with RenalGuard had a lower incidence rate of CIN than those treated with the current standard of care. It is one of a number of sessions related to Contrast-Induced Nephropathy taking place at this year's conference, and takes place Thursday, November 10, 12:15 PM – 1:45 PM (PT).
TCT, sponsored by the Cardiovascular Research Foundation, is being held November 7-11, 2011 in San Francisco, California. More than 12,000 clinicians and professionals from around the world are expected to attend this event.
RenalGuard is based on data that shows that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. RenalGuard has not been approved for sale in the U.S.; PLC Systems is beginning enrollment in its pivotal trial for RenalGuard to seek FDA approval to market the product in the U.S.
About PLC Systems Inc.
PLC Systems Inc., headquartered in Milford, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain imaging procedures. The Product is CE-marked and is being marketed in Europe and selected countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN. RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA, and has not been approved for patient use in the United States.
Additional company information can be found at www.plcmed.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, the U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if this clinical trial is completed, it may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, competitive developments that may affect the market for our products, regulatory approval requirements that may affect the market for our products, and additional risk factors described in the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2010, a copy of which is on file with the SEC.
PLC Systems, PLC Medical Systems, PLC, RenalGuard, RenalGuard Therapy and RenalGuard System are trademarks of PLC Systems Inc.
Contact: Mary T. Conway
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