First company to complete patient enrollment and treatment in phase II
trial for percutaneous use
Highlights
-- Q2 sales $1.1 million, net loss ($7.0) million for the quarter.
-- Completion of patient enrollment and treatment in Phase II Axcis(TM)
PMR randomized trial with over 290 "no-option" patients
-- FDA regulatory submission for the company's surgical ITMR System on
schedule
-- Clinical results with the company's ITMR and PMR Systems encouraging
-- Placement of lasers in Europe shows growth in Q2
SUNNYVALE, Calif., July 16 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP), a leader in transmyocardial revascularization (TMR)
technology, today reported results for the second quarter and six months ended
June 30, 1998.
Sales for the second quarter were $1.1 million, resulting from sales of
the company's Intraoperative Transmyocardial Revascularization (ITMR) and
Percutaneous Myocardial Revascularization (PMR) Systems, including disposable
components, to international customers and to clinical trial sites in the
United States. Second quarter 1998 sales decreased from sales of $2.7 million
for the second quarter of 1997. This reduction in sales is due primarily to
constraints on capital equipment purchases resulting from hospital budgets and
government overview outside the U.S., and by the limited current availability
of reimbursement for TMR procedures in Europe. Net loss for the quarter ended
June 30, 1998 was ($7.0) million, or a net loss of ($0.57) per share, versus a
net loss of ($3.7) million, or a net loss of ($0.31) per share for the second
quarter of 1997. (All per share amounts are presented on a diluted basis.).
The increase in the net loss is due primarily to lower sales volumes,
additional R&D expenditures and higher clinical expenses for increased
activity in clinical trials. At June 30, 1998, the company had cash, cash
equivalents and available-for-sale securities of $31.9 million.
"Although second quarter sales were lower than the prior year, we are very
encouraged by the increased placements of laser systems in Europe," commented
Allen W. Hill, CardioGenesis President and CEO. "The reception by
interventional cardiologists to our Axcis PMR System in both Europe and the
U.S. is very positive. The completion of the enrollment and treatment in the
U.S. pivotal prospective randomized trial for this system represents the
achievement by the company of a major milestone and extends our leadership in
percutaneous myocardial revascularization."
Hill continued, "Our modular Pre-Market Approval (PMA) submission of data
to the Food and Drug Administration (FDA) on the surgical ITMR System is
progressing according to schedule. We anticipate completing this submission
in the third quarter of 1998."
For the six months ended June 30, 1998, sales decreased to $1.9 million
from $4.3 million in the same period a year ago. The net loss for the six
month period was ($12.6) million compared to a net loss of ($7.3) million for
the first six months of 1997. The net loss per share for the six months ended
June 30, 1998 was ($1.03) compared to a net loss of ($0.61) per share for the
first half of 1997.
PMR (Percutaneous) Clinical Update
CardioGenesis announced last week that it has completed the enrollment and
treatment of patients in its pivotal prospective randomized Phase II trial of
its Axcis PMR System. All "no option" patients had severe coronary artery
disease and Class III or Class IV angina, were untreatable with bypass surgery
or balloon angioplasty and were taking the maximum recommended levels of
anti-anginal drugs.
The trial, which includes over 290 patients, is being conducted at 12
major cardiovascular treatment centers located in both the U.S. and Europe,
including Stanford University Medical Center, Johns Hopkins University Medical
Center, Baylor College of Medicine, the Mayo Clinic, and Papworth Hospital,
Cambridge, United Kingdom. CardioGenesis is currently conducting three, six
and twelve month patient follow-ups with the primary study outcome measures
being reduction in angina class and improvement in exercise tolerance.
"To be the first company to complete enrollment and treatment of patients
in a Phase II trial in PMR gives CardioGenesis a significant lead over its
competitors in the development of PMR. We believe the prospects are good that
over 70 percent of TMR patients will ultimately be treated with the
percutaneous approach," said Hill.
CardioGenesis is planning to pursue a modular submission for regulatory
approval and intends to submit information and updates for the formal follow
up period of the study. This proactive and collaborative approach to
submissions is intended to provide CardioGenesis a means for frequent reviews
by the FDA of information required for PMA of the Axcis PMR System.
ITMR (Surgical) Clinical Update
CardioGenesis continues to submit data and information on the
CardioGenesis ITMR System in a modular format to the FDA. 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. 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, Calif., develops,
manufactures and markets proprietary systems including disposable products, to
perform intraoperative transmyocardial revascularization (ITMR),
catheter-based percutaneous myocardial revascularization (PMR), and
thoracoscopic transmyocardial revascularization (TTMR), 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
percutaneous myocardial revascularization, U.S. Patent Numbers 5,389,096, and
5,554,152, intraoperative myocardial device revascularization, U.S. Patent
Number 5,380,316; and other patents in the field of transmyocardial
revascularization with a number of U.S. and international patent applications
pending. 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 release contain 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, and of 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 and the company's first quarter 1998 Form 10-Q
as filed with the Securities and Exchange Commission.
CARDIOGENESIS CORPORATION
STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended Six Months Ended
June 30 June 30
1998 1997 1998 1997
Sales $1,077 $2,701 $1,926 $4,284
Cost of sales 926 1,459 1,629 2,590
Gross profit 151 1,242 297 1,694
Operating expenses:
Research and development 4,366 3,250 8,176 6,504
General and administrative 1,572 921 2,909 1,692
Sales and marketing 1,696 1,496 2,838 2,297
Operating expenses 7,634 5,667 13,923 10,493
Operating loss (7,483) (4,425) (13,626) (8,799)
Interest income, net 504 713 1,059 1,492
Net loss $(6,979) $(3,712) $(12,567) $(7,307)
Net loss per common share
and per common share
- assuming dilution $(0.57) $(0.31) $(1.03) $(0.61)
Shares used in computing
net loss per common share
and per common share
- assuming dilution 12,199 12,003 12,167 11,992
CARDIOGENESIS CORPORATION
BALANCE SHEETS
(in thousands)
(unaudited)
June 30, December 31,
1998 1997
ASSETS
Current assets:
Cash and cash equivalents $9,934 $6,047
Available-for-sale securities 8,807 24,469
Accounts receivable, net 1,008 3,293
Inventories 1,401 1,109
Other current assets 1,635 1,751
Total current assets 22,785 36,669
Available-for-sale securities, non-current 13,131 10,019
Long term assets 1,799 1,552
Total assets $37,715 $48,240
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $5,726 $3,944
Deferred revenue - 150
Total liabilities 5,726 4,094
Stockholders' equity 31,989 44,146
Total liabilities and stockholders' equity $37,715 $48,240
Total cash, cash equivalents and
available-for-sale securities $31,872 $40,535
SOURCE CardioGenesis Corporation
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Related links:
http://www.cardiogenesis.com
CONTACT:
Allen W. Hill, President and CEO, or Richard
P. Powers, Executive Vice President and CFO, both of
CardioGenesis, 408-328-8500; or Ann Trunko, general information,
or Kate Rajeck, analyst contact, both of The Financial Relations
Board, 415-986-1591
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