Highlights
- Q1 sales $850,000, net loss ($5.6 million) for the quarter
- FDA regulatory submission for the ITMR(TM) System on schedule
- Clinical results on ITMR pivotal study are excellent
- Over 150 patients treated with Axcis(TM) PMR(TM) System
- Encouraging clinical results reported with CardioGenesis Axcis PMR
System
SUNNYVALE, Calif., April 15 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP), a leader in transmyocardial revascularization (TMR)
technology, today reported results for the first quarter ended March 31, 1998.
Sales for the first quarter were $850,000 resulting from sales of the
company's Intraoperative Transmyocardial Revascularization (ITMR) System and
Percutaneous Myocardial Revascularization (PMR) System, including disposable
components, to international customers and to clinical trial sites in the U.S.
First quarter sales decreased 50 percent from sales of $1.6 million for the
first quarter of 1997. This reduction in sales is due to the lack of
reimbursement in Europe and constraints placed on capital purchases by various
governments outside the U.S. Net loss for the quarter was ($5.6 million), or
($0.46) per share, compared to ($3.6 million), or ($0.30) per share, for the
first quarter of 1997. (All per share amounts are presented on a diluted
basis.) At March 31, 1998, the company had cash, cash equivalents and
available-for-sale securities of $37.7 million.
"We continue to make significant progress in both the areas of ITMR and
PMR," commented Allen W. Hill, CardioGenesis President and CEO. "Our
submission of data on the ITMR System to the Food and Drug Administration
(FDA) continues and the anticipated filing of the Pre Market Approval (PMA)
appears to be on schedule. We are also encouraged by the recent clinical
results that suggest that patients treated with the CardioGenesis Axcis PMR
System are achieving comparable improvement in angina class and exercise
tolerance as those treated with the ITMR System."
PMR Clinical Trial Results
More than 150 patients have been treated with the Axcis PMR System at
clinical centers worldwide. The company is currently in a pivotal prospective
randomized trial for PMR in "no option" patients.
Clinical data from a pilot clinical study in Europe presented at the
recent American College of Cardiology (ACC) Annual Conference in Atlanta, Ga.,
reported that patients treated with the Axcis PMR System experienced a
50 percent reduction in mean angina class and a significant improvement in
exercise tolerance. CardioGenesis was the first company to initiate clinical
studies of a minimally invasive percutaneous approach to transmyocardial
revascularization in Europe in November 1996 and in the U.S., the first
patient was treated in July 1997.
ITMR Clinical Trial Update
CardioGenesis continues to submit data and information to the FDA on the
CardioGenesis ITMR System. The company plans to continue submitting
information and updates to the FDA and to respond to periodic inquiries from
the FDA for the next several months with respect to review of such data and
information. This proactive and collaborative approach to submissions
provides CardioGenesis a means for frequent reviews by the FDA of information
required for PMA as well as discussions regarding the ITMR System. "We are
encouraged with the positive ITMR data and our progress in filing with the
FDA," said Hill. Clinical data from the company's prospective randomized
trial presented at recent medical symposia indicate patients who received
treatment with the ITMR System achieved approximately a two class drop in
angina class and a 45 percent improvement in exercise tolerance, as opposed to
no improvement in angina class or exercise tolerance in study patients who did
not receive the ITMR therapy.
CardioGenesis Corporation, based in Sunnyvale, California, develops,
manufactures and markets proprietary systems including disposable products, to
perform intraoperative transmyocardial revascularization, catheter-based
percutaneous myocardial revascularization, and thoracoscopic transmyocardial
revascularization, to treat patients afflicted with debilitating angina.
CardioGenesis catheter systems and probes deliver laser energy to create
channels in oxygen-deprived (ischemic) regions of the heart muscle
(myocardium). CardioGenesis holds patents for the system and method of
percutaneous myocardial revascularization, U.S. Patent Number 5,389,096, the
method of intraoperative myocardial device revascularization, U.S. Patent
Number 5,380,316; and other patents in the field of transmyocardial
revascularization. For more information on the company and its products,
visit the CardioGenesis website at http://www.cardiogenesis.com.
Please note: Except for the historical information contained herein, the
matters discussed in this news release are forward-looking statements that
involve risk and uncertainties, including: approval for and final results of
clinical studies; timing of regulatory approvals; reliance on Boston
Scientific Corporation as the exclusive distributor outside of the U.S. for
the company's products and pricing; potential third-party patent infringement
claims; the management of growth; and the effectiveness of the company's ITMR,
TTMR and PMR Systems, as well as related procedures. For further information,
refer to risk factors under the caption "Management's Discussion and Analysis
of Financial Condition and Results of Operations - Risk Factors" and elsewhere
in the company's 1997 Form 10-K as filed with the Securities and Exchange
Commission.
CARDIOGENESIS CORPORATION
BALANCE SHEETS
(in thousands)
(unaudited)
March 31, December 31,
1998 1997
ASSETS
Current assets:
Cash and cash equivalents $4,079 $6,047
Available-for-sale securities 12,340 24,469
Accounts receivable, net 815 3,293
Inventories 1,382 1,109
Other current assets 1,956 1,751
Total current assets 20,572 36,669
Available-for-sale securities, non-current 21,236 10,019
Long term assets 1,832 1,552
Total assets $43,640 $48,240
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $4,794 $3,944
Deferred revenue -- 150
Total liabilities 4,794 4,094
Stockholders' equity 38,846 44,146
Total liabilities and stockholders'
equity $43,640 $48,240
CARDIOGENESIS CORPORATION
STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months Ended March 31
1998 1997
(unaudited)
Sales $850 $1,583
Cost of sales 703 1,131
Gross profit 147 452
Operating expenses:
Research and development 3,811 3,254
General and administrative 1,338 771
Sales and marketing 1,141 801
Operating expenses 6,290 4,826
Operating loss (6,143) (4,374)
Interest income, net 555 779
Net loss $(5,588) $(3,595)
Net loss per common share
and per common share
- assuming dilution $(0.46) $(0.30)
Shares used in computing
net loss per common share
and per common share
- assuming dilution 12,134 11,982
SOURCE CardioGenesis Corporation
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Related links:
http://www.cardiogenesis.com
CONTACT:
Allen W. Hill, President and CEO, or Richard
P. Powers, Vice President and CFO, both of CardioGenesis,
408-328-8500; or Ann Trunko, General Information, or Kate Rajeck,
Analyst Contact, 415-986-1591, both of The Financial Relations
Board
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