PLC Medical Systems To Demonstrate RenalGuard(R) At EuroPCR 2009
PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, announced that it will demonstrate its RenalGuard System(TM) at EuroPCR, the annual meeting of... the European Association of Percutaneous Cardiovascular Interventions (EAPCI), May 19-22, 2009, in Barcelona, Spain. More than 11,000 clinicians and professionals are expected to attend this event.
In addition, RenalGuard(R) will be included as part of a live case transmission from Hospital Clinico San Carlos, Madrid, Spain during the meeting. The interventional cardiologists involved in the case plan to demonstrate how RenalGuard is used to help prevent Contrast-Induced Nephropathy (CIN) in a patient with impaired renal function undergoing a Percutaneous Coronary Intervention (PCI).
"Following the spirit of EuroPCR, our commitment during these live cases is to provide valuable clinical education to EuroPCR attendees," stated Dr. Javier Escaned, Consultant Interventional Cardiologist, Hospital Clinico. "I consider that creating awareness of the problem of CIN and disseminating new information on how to prevent it are very important."
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are very pleased to be presenting RenalGuard to this important audience, and especially pleased that Dr. Escaned will be demonstrating a live case illustrating how RenalGuard works and how it may benefit patients. CIN is a significant and growing concern worldwide, and we are very encouraged by the prospect that RenalGuard could remedy it."
Currently, RenalGuard is the subject of an investigator-sponsored trial to study its efficacy in mitigating against CIN at the University of Milan-Centro Cardiologico Monzino (CCM). The trial is designed to provide an assessment of the potential benefits of induced diuresis with matched hydration therapy compared to standard overnight hydration, a prevalent method of treatment in the EU, in the prevention of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The CIN-prevention therapy of induced diuresis and matched hydration therapy will be provided using RenalGuard.
PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received full approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in the prevention of CIN. In March 2008, PLC signed its first international distribution agreement for RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy, and in May 2009, PLC announced its second European distributor, IZASA Distribuciones Tecnicas S.A., headquartered in Barcelona, Spain, for the distribution of RenalGuard in Spain.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device.
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, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, the current clinical trial in Italy and the planned future U.S. clinical trial for RenalGuard as a safe and effective prevention device for contrast induced nephropathy may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements 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, 2008, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Source: PLC Systems Inc
In addition, RenalGuard(R) will be included as part of a live case transmission from Hospital Clinico San Carlos, Madrid, Spain during the meeting. The interventional cardiologists involved in the case plan to demonstrate how RenalGuard is used to help prevent Contrast-Induced Nephropathy (CIN) in a patient with impaired renal function undergoing a Percutaneous Coronary Intervention (PCI).
"Following the spirit of EuroPCR, our commitment during these live cases is to provide valuable clinical education to EuroPCR attendees," stated Dr. Javier Escaned, Consultant Interventional Cardiologist, Hospital Clinico. "I consider that creating awareness of the problem of CIN and disseminating new information on how to prevent it are very important."
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are very pleased to be presenting RenalGuard to this important audience, and especially pleased that Dr. Escaned will be demonstrating a live case illustrating how RenalGuard works and how it may benefit patients. CIN is a significant and growing concern worldwide, and we are very encouraged by the prospect that RenalGuard could remedy it."
Currently, RenalGuard is the subject of an investigator-sponsored trial to study its efficacy in mitigating against CIN at the University of Milan-Centro Cardiologico Monzino (CCM). The trial is designed to provide an assessment of the potential benefits of induced diuresis with matched hydration therapy compared to standard overnight hydration, a prevalent method of treatment in the EU, in the prevention of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The CIN-prevention therapy of induced diuresis and matched hydration therapy will be provided using RenalGuard.
PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received full approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in the prevention of CIN. In March 2008, PLC signed its first international distribution agreement for RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy, and in May 2009, PLC announced its second European distributor, IZASA Distribuciones Tecnicas S.A., headquartered in Barcelona, Spain, for the distribution of RenalGuard in Spain.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device.
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, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, the current clinical trial in Italy and the planned future U.S. clinical trial for RenalGuard as a safe and effective prevention device for contrast induced nephropathy may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements 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, 2008, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Source: PLC Systems Inc