CARDIOGENESIS REPORTS 2002 FOURTH QUARTER, YEAR END RESULTS
liabilities recorded in the first three quarters of 2002 in connection with the Company's
management incentive program. The net loss in the fourth quarter of 2001 was $2.4 million, or
$0.07 loss per fully diluted share.
Revenues for the full 2002 year were $13.0 million, with a net loss of $530,000, or $0.01
fully diluted loss per share, compared to 2001 revenues of $14.2 million, with a net loss of $10.2
million, or $0.31 loss per fully diluted share. The 2002 results included the effects of recording
in the third and fourth quarters a total of $1.3 million in reductions of accrued liabilities recorded
in prior years for estimated clinical trial obligations and the $2.3 million one-time gain recorded
in the second quarter from the sale of the Company's minority interest in a privately held
Excluding the effect of the reduction of accruals, the loss from operations in 2002 was cut
to $4.1 million, less than half the $9.6 million loss from operations recorded in 2001.
"We believe we are well positioned to become profitable with our TMR business in
2003," Quinn added. "TMR is a procedure that has improved the lives of patients suffering from
advanced cardiovascular disease, and we now have strong five-year follow-up data from a multi-
center study that clearly demonstrates the long term efficacy and patient benefits of TMR. As
the procedure gains acceptance, our pipeline grows stronger."
Quinn said that the Company is committed to PMR, its less invasive, catheter-based
version of TMR, and it is very encouraged by the FDA's recent decision, which CardioGenesis
announced yesterday, to grant the Company an impartial forum for consideration of PMR by a
new independent panel of qualified experts. "We are confident that the PMA supplement we
submitted last year contains adequate valid scientific evidence to support a determination by the
panel of the reasonable safety and efficacy of PMR.
"Although we did not obtain regulatory approval of PMR in 2002," Quinn added, "we
have continued to work closely this year with the FDA to do everything we can to obtain
clearance of this less invasive approach to this quality of life enhancing therapy. Now that we
have been granted an independent panel review through the dispute resolution process, we intend
to work diligently to bring PMR to the tens of thousands of late stage coronary artery disease
patients in the US searching for effective treatment of their crippling angina pain."
During the fourth quarter of 2002, the Company shipped six lasers and worldwide
disposable sales exceeded 820 units; for the year 21 lasers were shipped and worldwide
disposable sales were 3,034 units.
At the end of 2002, there were 425 sites using CardioGenesis lasers for myocardial
revascularization, up from the 413 sites at the end of 2001. Over 100 additional cardiothoracic
surgeons were trained in 2002, and a large number of surgeons trained in prior years also
attended advanced TMR training in 2002. The Company's dominant share of the laser-based
cardiac revascularization market includes substantial penetration in the top cardiovascular
institutions in the U.S.