Agreement with Major Player Provides Powerful International Leverage
MILFORD, Mass. — PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that it had signed an agreement with ACIST Medical Systems, Inc., a Bracco Group company, to distribute its innovative RenalGuard System™ in France and Germany.
Under the terms of the agreement, ACIST will be the exclusive distributor of PLC's RenalGuard® in the two largest countries in the European Union, expanding RenalGuard's distribution significantly in Europe, where PLC has secured the CE Mark for its RenalGuard device. As part of the agreement, ACIST will purchase an initial stocking order of RenalGuard consoles and single use sets.
"Today's news is a critical catalyst to enable PLC to expand the use of RenalGuard in the largest countries in Europe," said Mark R. Tauscher, President and Chief Executive Officer of PLC Systems. "ACIST brings enormous credibility to our effort to increase the number of patients who can access RenalGuard. We're confident that in partnership with them, we'll be able to reach many more hospitals and healthcare institutions to allow clinicians to utilize RenalGuard to protect patients."
Recent positive scientific data from investigator-sponsored clinical trials of RenalGuard in Europe have been presented at major international medical conferences and published in peer-reviewed journals. The results from these trials showed that RenalGuard is superior to the current standard of care in preventing Contrast-Induced Nephropathy (CIN), a potentially fatal injury to the kidney that occurs when at-risk patients undergo certain imaging procedures. More than 15% of the patients in the more than 7 million imaging procedures conducted worldwide each year are considered at-risk of acquiring CIN, based upon their age and other criteria.
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. RenalGuard Therapy, based on the concept that high urine output is beneficial to patients with impaired baseline renal function who receive intravascular iodinated contrast agents, was also found in European clinical trials to significantly reduce the need for in-hospital dialysis in high risk patients.
PLC already has distribution agreements for RenalGuard in Italy, Spain, Portugal, The Netherlands, Austria, Belgium, Croatia,Luxembourg, Monaco and Switzerland in Europe, as well as in select other countries around the world. The company is finalizing preparations for its U.S. pivotal trial of RenalGuard, which is required in order to secure approval from the U.S. Food & Drug Administration to market and sell RenalGuard 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.
About ACIST Medical Systems
ACIST Medical Systems, a Bracco Group company, is a market leader in the development of innovative and advanced contrast imaging system technologies for cardiovascular and radiological applications. Since 1998, ACIST has manufactured more than 2,200 advanced, variable-flow contrast delivery systems for cardiologists in more than 45 countries. In 2011, ACIST reached a milestone with more than 10 million patients having undergone a cardiovascular angiography procedure using an ACIST Contrast Delivery System. Headquartered in Eden Prairie, Minn., with regional offices in Europe and Asia, ACIST employs more than 220 people worldwide. To learn more, visit www.acist.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 planned future U.S. clinical trial for RenalGuard 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 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.