More than Half of the Estimated 2,700 Minimally Invasive Bypasses Were
Multi-Vessel Procedures
CUPERTINO, Calif., Feb. 3 /PRNewswire/ -- CardioThoracic Systems, Inc.
(CTS) (Nasdaq: CTSI) today reported financial results for the fourth quarter
and year ended January 2, 1998.
For the fourth quarter, net revenues were $2.8 million compared with
revenues of $141,000 in the fourth quarter of 1996. Net loss for the quarter
was $6.9 million, or $0.51 per common share assuming dilution on 13.6 million
weighted average shares outstanding compared to a net loss of $4.9 million, or
$0.38 per share on 13.0 million weighted average shares outstanding in the
fourth quarter of 1996. During the quarter, the company incurred a
$1.0 million research and development charge for a milestone payment relating
to a development contract.
For the year ended January 2, 1998, CTS reported net revenues of
$9.4 million compared with revenues of $141,000 in 1996. Net loss for the
twelve month period was $22.4 million, or $1.66 per common share assuming
dilution on 13.5 million weighted average shares outstanding, versus a net
loss $16.1 million, or $1.36 per share on 11.8 million weighted average shares
outstanding, in the prior year. As of January 2, 1998, CTS had cash, cash
equivalents and available-for-sale securities of $60.8 million.
The company estimates that during the quarter over 2,700 minimally
invasive (beating heart) coronary artery bypass surgeries were performed using
the company's second generation system, the CTS Access MV(TM) System, of which
more than 1,400 were double and triple vessel procedures. Since the
commercial launch of the Access MV multi-vessel system in late September 1997,
CTS' key institutions alone performed over 740 multi-vessel minimally invasive
bypass surgeries.
"The acceptance of the CTS Access MV System is further evidence of a
growing consensus among leading bypass centers worldwide that patients can
benefit from beating heart bypass surgery. Given the growing adoption of our
second generation system, we believe that by the end of 1998, over 75 percent
of all bypass surgeries using CTS systems will be multi-vessel," stated
Richard Ferrari, CTS president and CEO.
Also during the quarter, CTS continued to enroll patients in its POEM
(Patency, Outcomes and Economics of MIDCAB(TM)) Study. The POEM Study,
launched in the third quarter of 1997, is the first multicenter controlled
study comparing minimally invasive direct coronary artery bypass (MIDCAB) with
traditional coronary artery bypass graft (CABG) procedures. The company
expects the study to be completed during the second half of this year.
The CTS MIDCAB Registry, a compilation of data from more than
1,100 patients on which the MIDCAB procedure was performed, was presented at
the American Heart Association (AHA) Conference in November 1997. The
Registry data documents a patency rate of 97 percent, a stroke rate of
one-tenth of one percent and a mortality rate of one percent. These outcomes
compare favorably to traditional CABG results. CTS recently announced the
launch of its new OPCAB(TM) (Off-Pump Coronary Artery Bypass) Patient Registry
which will include pre-, intra- and post-operative data on patients undergoing
single and multiple vessel off-pump minimally invasive coronary artery bypass
surgery.
"Both the POEM Study and the CTS Registries demonstrate our commitment to
clinical leadership in the minimally invasive cardiac surgery field. In
addition, we continue to focus on providing extensive training for surgical
teams through our CORiculum(TM) Institutes which conducted their first
advanced sessions during the fourth quarter addressing techniques for
multi-vessel off-pump coronary artery bypass graft surgery," said Ferrari.
CTS introduced its first generation system for minimally invasive beating
heart bypass surgery, the CTS MIDCAB(TM) System, in January 1997. Since that
time, over 8,000 beating heart bypass procedures, including midline and
thorocotomy approaches, have been performed using CTS's proprietary platform
and stabilizer.
CardioThoracic Systems, Inc., Cupertino, Calif., is a leading developer of
proprietary technologies in minimally invasive cardiothoracic surgery. The
company's current products are designed to enable cardiothoracic surgeons to
perform minimally invasive (beating heart) bypass surgery on a beating heart.
CTS is also developing technologies in the areas of minimally invasive valve
repair and replacement and saphenous vein harvesting. The company's stock is
traded on the Nasdaq Stock Market under the symbol CTSI.
All earnings per share amounts represent diluted earnings per share as
defined by the Statement of Financial Accounting Standards No. 128. Diluted
earnings per share calculations include the dilutive impact of stock options
issued to employees under CTS' stock option plans and results in the same
shares outstanding and earnings per share amounts previously reported as
primary earnings per share.
This news release contains forward-looking information that involves risks
and uncertainties, including uncertainties associated with the number of
multi-vessel procedures that may be performed using CTS products, the
capabilities of the CTS instrumentation, the market acceptance of the CTS
Access MV System and other products, procedures and programs, the results of
procedures performed using the company's products and the success of the
company's development efforts. Actual results may differ significantly from
the results discussed in the forward-looking statements as a result of those
and other factors, including factors set forth in the company's annual report
on Form 10-K filed with the Securities and Exchange Commission on
March 31, 1997 and the company's most recent quarterly report on Form 10-Q
filed with the Securities and Exchange Commission on November 7, 1997. Copies
of the Annual Report on Form 10-K are available by calling the company's
investor relations department at 408-342-1700.
For more information on CardioThoracic Systems, Inc. via fax at no cost,
dial 800-PRO-INFO or 908-544-2850 outside the U.S. Ticker symbol: CTSI.
CARDIOTHORACIC SYSTEMS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended Year Ended
January 2, December 31, January 2, December 31,
1998 1996 1998 1996
Net sales $2,802,000 $141,000 $9,379,000 $141,000
Cost of sales 1,631,000 629,000 5,962,000 842,000
Gross profit 1,171,000 (488,000) 3,417,000 (701,000)
Operating expenses:
Research and
development 3,527,000 3,195,000 10,806,000 11,475,000
Sales, marketing,
general and adm. 5,315,000 2,318,000 18,620,000 6,977,000
Total operating
expenses 8,842,000 5,513,000 29,426,000 18,452,000
Loss from
operations (7,671,000) (6,001,000) (26,009,000) (19,153,000)
Interest income,
net 723,000 1,086,000 3,645,000 3,075,000
Net loss $(6,948,000) $(4,915,000) $(22,364,000) $(16,078,000)
Net loss per common
share and per
common share
assuming dilution $(0.51) $(0.38) $(1.66) $(1.36)
Shares used in
computing net
loss per share 13,637,000 12,984,000 13,505,000 11,810,000
CONDENSED BALANCE SHEETS
(in thousands)
January 2, 1998 December 31, 1996
Cash, cash equivalents and
available-for-sale
securities $60,834 $78,457
Total current assets 60,490 49,330
Property and equipment, net 3,613 2,495
Total assets 69,276 83,691
Total current liabilities 5,619 3,310
Total stockholders' equity $60,134 $79,254
SOURCE CardioThoracic Systems, Inc.
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CONTACT: Richard M. Ferrari (CEO) or Steve Van Dick (CFO) of CardioThoracic Systems, Inc., 408-342-1700; or Ann Trunko, general information, or Kate Rajeck, analyst contact, of The Financial Relations Board, 415-986-1591, for CardioThoracic Systems
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