CARDIOGENESIS REPORTS THIRD QUARTER, NINE-MONTH RESULTS
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Quinn said that the Company's regulatory team has taken a number of significant steps
forward and is working closely with the FDA in the review of the important and substantial clinical
amendment to the PMA Supplement for PMR it filed early in the third quarter. "We are engaged in
ongoing and productive discussions with the FDA review team to answer specific questions raised
during the process," Quinn added. "I am confident in the prospects for approval in the near future
because the leading clinical investigators and well-regarded independent experts who have reviewed
our clinical amendment believe it establishes the reasonable safety and effectiveness of the PMR
procedure.
"I am also optimistic that we will have a definitive resolution of the FDA's review process
for PMR before year end, which will provide us a clear indication of the remaining few steps
needed for what we and our outside clinical investigators and independent experts believe will be
an approval to market PMR in the U.S.," Quinn said.
Revenues for the first nine months of 2002 were $9.4 million, with a net loss of $678,000 or
a $0.02 fully diluted loss per share. The 2002 results included the effects of the $684,000 reduction
taken in the third quarter of the accrued liabilities in research and development expenses and the
$2.3 million one-time gain recorded in the second quarter from the sale of the Company's minority
interest in privately held Microheart, Inc.
Revenues for the first nine months of 2001 were $11.4 million, with a net loss of $7.9
million, or a $0.24 fully diluted loss per share. Results for the first nine months of last year
included the effects of equity losses from the Company's minority ownership of Microheart
recognized in the first and second quarters of that year and organizational restructuring charges
taken in the 2001 second and third quarters, both totaling approximately $1.8 million.
Excluding the effect of the reduction of accruals, the loss from operations in this year's first
nine months was cut almost in half to $3.7 million, down from $7.3 million in the year earlier
period.
The Company's current strategy of concentrating its sales resources on increasing procedure
volume in its existing installed base has, as anticipated, had the effect of reducing revenues from
laser placements and outright laser sales, when compared to the levels attained in the first nine
months of 2001. The decline in new laser placements, when compared to prior year periods, has
resulted in a year-over-year reduction in the number of hand pieces sold as each shipped laser is
normally accompanied by an order for several hand pieces.
During this year's third quarter, the Company placed three lasers, sold two lasers outright,
converted one installed laser to a sale and had worldwide hand piece sales of 747 units. This
compares to the placement of 12 lasers, the outright sale of six lasers, the conversion of two
installed lasers to sales and worldwide hand piece sales of 940 units in the third quarter of 2001. At
the end of the 2002 third quarter, there were 420 sites with CardioGenesis lasers for myocardial
revascularization, up from 414 sites at the end of the third quarter of 2001. The total number of
surgeons trained as of September 30, 2002 had risen to 1,090 from the 974 trained at the end of the
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