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To: Bucky Katt who wrote (10233)	1/15/2003 9:24:26 AM
From: BW	Read Replies (2) \| Respond to of 48461

CGCP news - CardioGenesis Expects to Report Increase in Fourth Quarter Revenue Wednesday January 15, 7:32 am ET Company Believes It Can Reach Profitability During 2003; Reaffirms Commitment to PMR FOOTHILL RANCH, Calif., Jan. 15 /PRNewswire-FirstCall/ -- CardioGenesis Corporation (Nasdaq: CGCP - News), the market leader in angina- relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Revascularization (PMR), today announced that it expects to report revenues in the range of $3.5 million to $3.7 million for the fourth quarter ended December 31, 2002, a more than 25 percent increase in revenues from the same period in 2001. The solid fourth quarter results were due to strong hand piece and laser sales, both indicators of increasing TMR utilization, and bode well for the Company's ongoing campaign to expand the use of TMR and become profitable in 2003, said Chairman and CEO Michael J. Quinn. The fourth quarter revenues rose more than 10 percent and worldwide hand piece sales increased by about 10 percent over the 2002 third quarter. ADVERTISEMENT "We are developing a solid pipeline for our TMR franchise and, if we continue to execute well and continue to control our costs, we believe we can reach profitability in 2003," Quinn said. "While revenues for the first quarter of this year may not show the same level of year-to-year increases as the 2002 fourth quarter, we expect to see gains in revenue and market share for the upcoming year with the attainment of a profitable run rate in the second half of the year." The Company plans to release its full results for the fourth quarter and year ended December 31, 2002, in late February with management hosting a conference call to discuss those results at 11 a.m. EST on the same day. Quinn also said that recent delays in the regulatory approval of PMR, the Company's catheter-based version of TMR, does not reduce its desire to make PMR available to the tens of thousands of patients in the U.S. who could be helped by the quality of life enhancing benefits of this minimally invasive procedure. CardioGenesis is exploring all its strategic options focused on securing regulatory approval of PMR from the U.S. Food and Drug Administration and remains dedicated to the innovative therapy. "PMR is a less invasive route of administration of the Ho:YAG laser therapy than the already FDA approved surgical TMR procedure," Quinn commented. "We remain confident in the clinical results achieved as reported in our PMA (Pre Market Approval) supplement for PMR to the FDA and are preparing our responses to the agency's most recent requests for additional information. We will do everything we can to work with the FDA to achieve approval of PMR." According to Quinn, the Company expects its TMR business to be buoyed by follow-up data announced earlier this month that showed almost all the surviving patients from two centers that participated in the Company's pivotal clinical trial conducted from March 1996 to July 1998 are still enjoying the benefits of TMR five years after undergoing the surgical procedure. The data from the two centers shows that 96 percent of the patients in the follow-up study exhibited a reduction in pain of at least two angina classes five years after their initial TMR treatment and incremental pain reductions occurred after one year. Keith Allen, M.D., a leading cardiovascular surgeon who directed the study, said that the enduring relief from angina pain demonstrated by the new data should help dispel any lingering fears that TMR's benefits are transitory or due to a placebo effect. "These results demonstrate that TMR works well for patients with advanced cardiovascular disease," Quinn added. "Thanks to the increases in the acceptance of TMR we are seeing and this new five-year clinical data that shows its benefits are lasting and durable, we believe we are better positioned than ever for the TMR business to become robust and profitable." TMR and PMR are related procedures in which physicians use lasers to create small channels in the heart muscle to trigger the mechanisms of angiogenesis, or the creation of new blood vessels in the heart. The FDA approved TMR, a surgical version of the procedure, in 1999. PMR is a catheter-based version of the procedure that is not yet cleared by the FDA in the U.S., but is CE approved. The Company is continuing to move ahead in its efforts to gain FDA clearance this year to market PMR in the U.S. and extend the benefits of that minimally invasive procedure well beyond the 2,000 patients who have already been successfully treated with PMR.