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PLC Systems Inc. (OTCBB: PLCSF), a medical device company focused on innovative technologies for the cardiac and vascular markets, today reported financial results for the three and 12 months ended December 31, 2012.
Highlights of the fourth quarter of 2012 and recent weeks include:
Revenues were $485,000 in the fourth quarter of 2012, compared with $189,000 in the fourth quarter of 2011, an increase of 157%
Shipped first stocking orders to Brazil and made continued progress across Latin America to secure regulatory approvals for RenalGuard
Continued to broaden awareness of Contrast-Induced Nephropathy (CIN) with presence at Transcatheter Cardiovascular Therapeutics (TCT) 2012, a key medical conference
Raised $4.0 million in gross proceeds from an equity financing in February 2013
“RenalGuard sales during the fourth quarter showed a marked improvement as we filled a large stocking order to Discomed, our distributor in Brazil,” commented Mark Tauscher, president and chief executive officer of PLC Systems. “We worked for more than a year to secure the necessary approvals from Brazilian regulatory authorities, and are making progress in our efforts to receive regulatory approvals across Latin America via our distributor Girlow USA.”
Mr. Tauscher added, “We continue to enroll patients into our pivotal trial to support a Premarket Approval filing for RenalGuard with the U.S. Food and Drug Administration to reduce the onset of CIN. We raised $4.0 million in gross proceeds in an equity offering during the first quarter of 2013. Of the estimated 7.0 million diagnostic and interventional imaging procedures performed worldwide each year that involve the use of contrast agents, we believe that 15% or approximately 1.0 million patients could be considered at-risk for CIN and thus benefit from RenalGuard.
“We are continuing work to expand the awareness of the serious damage to kidneys that may result from CIN. During the fourth quarter of 2012, we had a well-attended booth at an important medical conference, the Transcatheter Cardiovascular Therapeutics meeting in Miami. Although the meeting was held in the U.S., the majority of attendees were from countries where we have distribution, and we were particularly pleased with the efforts of Artech, our distributor in Italy, and ACIST, our distributor in France and Germany. A panel discussion on the prevention of CIN using matched hydration served to highlight the need for prevention of this disease and the efficacy of RenalGuard. We look forward to attending EuroPCR, the annual meeting the European Association for Percutaneous Cardiovascular Interventions in May in Paris. RenalGuard will be well-represented there,” Mr. Tauscher concluded.