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Third quarter 2007 total revenues were $1,331,000 compared with $1,567,000 in the third quarter of 2006. The net loss for the third quarter of 2007 was $499,000, or $0.02 per diluted share, compared to a net loss of $80,000, or $0.00 per diluted share, in the third quarter of 2006.
"Our third quarter U.S. TMR revenues and kit shipments to hospitals were down compared to the corresponding third quarter in 2006. After detailed analysis and dialogue with our new U.S. distribution partner, Novadaq Technologies, Inc., we believe that we have identified the issues and that Novadaq is taking the right steps to address them and position the business for improved performance moving ahead," said Mark. R. Tauscher, president and chief executive officer of PLC Systems.
In March 2007 Novadaq succeeded Edwards Lifesciences Corporation as the Company''s exclusive distributor for all TMR products in the United States. Tauscher stated, "We had anticipated from the beginning that there would be at least one or two transition quarters where Novadaq would need to gain experience as to how to best market our TMR products and that this likely could impact our short term TMR results. We believe that in large part this is what happened in the third quarter on the disposables side of the business, and that Novadaq is acting quickly to reorganize their field sales structure, and add additional experienced staff, to better enable them to drive increased kit volumes in ensuing quarters."
He added, "Novadaq senior management has also indicated to us that the previously announced shortage in the availability of new ICG dye throughout the third quarter likely adversely impacted the placement by customers of combined orders for our TMR Heart Laser and Novadaq''s SPY® Intra-Operative Imaging System. The joint marketing of both systems has been a key Novadaq sales strategy. Novadaq announced on October 4, 2007 that all issues related to the shortage of new ICG dye had been resolved and that they were moving quickly to execute on the existing pipeline of new installations."
Regarding the Company''s RenalGuard(TM) product initiative, Mr. Tauscher said, "We expect to complete our pilot clinical safety trial by late 2007 or early 2008, and then quickly move into a larger U.S. multi-center pivotal trial to study the effectiveness of RenalGuard in reducing the incidence of Contrast-Induced Nephropathy (CIN). This pivotal clinical trial of our RenalGuard System and RenalGuard Therapy is expected to continue through 2009 and should serve as the basis for our application to the FDA for pre-market approval to market the product in the United States. Having recently demonstrated RenalGuard to leading practitioners at the two foremost tradeshows in the field in the U.S., TCT and Renal Week, we are confident that RenalGuard is addressing a sizable market opportunity. We were gratified by the level of interest expressed by practitioners who attended the shows from around the world."
He added, "We are very pleased to announce today, that in addition to our planned U.S. clinical trial work in 2008, a new clinical study utilizing our RenalGuard System and Therapy is expected to be initiated at the Centro Cardiologico Monzino (CCM- University of Milan) in Milan, Italy, led by Drs. Antonio Bartorelli and Giancarlo Marenzi, two of the world''s leading experts in CIN prevention. We anticipate that this study will greatly increase the visibility of our RenalGuard System and Therapy throughout the European Union, and will be instrumental in supporting our initial limited launch of the product in Italy. We believe we are still on track to receive CE mark approval for RenalGuard before the end of the year, which we expect would allow us to begin our launch in Italy in early 2008."
The CCM clinical study is expected to begin in the first quarter of 2008, pending approval from the ethics committee at the hospital. The study is designed to compare the effectiveness of induced high volume diuresis using real-time matched fluid replacement provided by the RenalGuard System with that of overnight hydration, a standard of care prevalent in Europe, in preventing CIN in high risk patients. PLC will be supplying the necessary RenalGuard devices to be used in the study.
Third Quarter TMR Laser and Kit Shipment Results
During the third quarter of 2007, PLC shipped three CO2 Heart Lasers (HL2) to U.S. hospitals through Novadaq. Two of these shipments were new HL2 lasers and one was a redeployed unit. PLC ended the third quarter of 2007 with 165 HL2 CO2 Heart Lasers located at heart centers throughout the U.S. During the third quarter of 2007, a total of 315 disposable kits were shipped worldwide by Novadaq and PLC. Novadaq delivered 313 of these kits to U.S. hospitals and PLC shipped two disposable kits to international customers. In comparison, a total of 454 and 515 disposable kits were delivered worldwide during the second quarter of 2007 and the third quarter of 2006, respectively.
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