Nov 11 2009
PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today reported financial results for the three and nine month periods ended September 30, 2009.
Third quarter 2009 total revenues were $1,023,000, down from $1,598,000 in the third quarter of 2008. The net loss for the third quarter of 2009 was $358,000, or $0.01 per diluted share, compared to a net loss of $285,000, or $0.01 per diluted share, in the third quarter of 2008.
Mark R. Tauscher, president and chief executive officer of PLC Systems Inc., stated, "This past quarter saw the first public release of very positive preliminary data from the clinical trial of our RenalGuard System(TM) in Italy. The data was presented at two significant medical conferences: in Spain in late August and a month later in the U.S., providing us with important opportunities to respond to growing interest from practitioners and potential distributors about RenalGuard®. In the initial data, only 4.6% of patients treated with RenalGuard in the trial acquired Contrast- Induced Nephropathy (CIN) whereas 14.9% of the patients in the control group were determined to have acquired CIN, thus demonstrating an advantage to using RenalGuard with the ever-growing segment of at-risk patients undergoing imaging procedures."
He added, "We have always believed that positive data from the Italian clinical study would drive additional distributor agreements, and our announcement today of a distribution agreement in Brazil, a very large potential market for RenalGuard, confirms our confidence. Based upon the number of discussions in which we are now engaged for potential distribution around the world, we are very pleased with the results of our participation in these conferences As the number of distributors has increased, with RenalGuard now on the market in Italy, Spain, Bangladesh and Pakistan, we also hope to use the heightened interest to generate stronger sales."
Separately, PLC announced today that that it has entered into a five year exclusive agreement with DISCOMED Comercio de Produtos Hospitalares Ltda., of Porto Alegre, Brazil, for distribution of its RenalGuard System(TM) in Brazil. DISCOMED is an established distributor of medical technology and devices in Brazil. DISCOMED is applying for an import license through ANVISA, the Brazilian registration authority, and expects approval in approximately 9 months.
PLC shipped 275 single use sets associated with its RenalGuard System internationally during the third quarter of 2009, along with nine consoles, associated with its launch of RenalGuard in Italy and Spain. In comparison, the company shipped 50 RenalGuard sets and five consoles in the third quarter of 2008.
During the third quarter of 2009, 223 disposable TMR kits were shipped, consisting of 218 kits shipped to hospitals in the U.S. by Novadaq Technologies, PLC's U.S. TMR marketing and distribution partner, and five kits shipped internationally by PLC. In comparison, a total of 409 disposable TMR kits were shipped worldwide during the third quarter of 2008.
PLC recorded no new domestic or international laser sales during the third quarter of 2009. In the same quarter of 2008, PLC shipped three new CO2 Heart Lasers (HL2). PLC ended the third quarter of 2009 with 168 HL2 lasers located at heart centers throughout the U.S.
Nine Months Results
For the first nine months of 2009, total revenues were $3,810,000, compared to $4,076,000 in the same period of 2008. The net loss for the first nine months of 2009 was $1,023,000, or $0.03 per share, compared to a net loss of $1,718,000, or $0.06 per share, in the first nine months of 2008.