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Conceptus Announces 1Q98 Financial Results.


SAN CARLOS, Calif.--(BW HealthWire)--April 27, 1998--Conceptus, Inc., (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:CPTS CPTS Certified Penetration Testing Specialist (network security)
CPTS Comptroller Squadron
CPTS Computer Program Test Specifications
CPTS Catastrophe Personnel Tracking System
CPTS Claims Procedure Training Specialist
), a leading company in the emerging women's health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 market, announced today the financial results for its first quarter of 1998.

The Company reported first quarter net sales Net Sales

The amount a seller receives from the buyer after costs associated with the sale are deducted.

Notes:
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight
 of $167,000, a 40% decrease over the same period last year. The Company also reported a net loss of $3,456,000 or $0.36 per share for the first quarter compared with a net loss of $2,796,000 or $0.30 per share for the same period last year. The majority of the sales shortfall for the quarter was caused by the failure of Conceptus's distributor of the FUTURA(tm) Resectoscope resectoscope /re·sec·to·scope/ (-sek´to-skop) an instrument with a wide-angle telescope and an electrically activated wire loop for transurethral removal or biopsy of lesions of the bladder, prostate, or urethra.  Sleeve, Imagyn Medical Technology (NASDAQ:IMTI IMTI Integrated Manufacturing Technologies Institute
IMTI Industrial Management Training Institute (Waterbury Connecticut and New York City)
IMTI Integrated Manufacturing Technology Initiative
IMTI International Mobile Terminal Identity
), to order its contracted first quarter minimums of $250,000.

Since the marketing and distribution agreement between Conceptus conceptus /con·cep·tus/ (-tus) the product of the union of oocyte and spermatozoon at any stage of development from fertilization until birth, including extraembryonic membranes as well as the embryo or fetus.  and Imagyn requires the distributor to either purchase or pay for its contracted quarterly minimums, Conceptus billed the distributor $250,000 for the quarter. Conceptus will not recognize this income until it is received. In addition, Conceptus's sales of the gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic.  configuration of its Microgyn technology, the ERA(tm) Resectosope Sleeve, were impacted by the Company's decision to defer adding planned direct sales representatives, due to ongoing negotiations to acquire a small private medical device company which has a direct US gynecological sales force. The Company ended the quarter with cash and cash equivalents in excess of $23 million.

During the quarter, Conceptus received clearance of a 510(k) from the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) for the Stargate(tm) catheter, a component of the Company's STARRT Falloposcopy System. The Stargate catheter was designed to reduce the incidence of "white out", a common occurrence in endoscopy endoscopy

Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the
 caused by excessive light reflection which obscures the image. The Company believes that the use of its STARRT Falloposcopy system which involves transcervical access to the fallopian tubes Fallopian tubes
The narrow ducts leading from a woman's ovaries to the uterus. After an egg is released from the ovary during ovulation, fertilization (the union of sperm and egg) normally occurs in the fallopian tubes.
, can in many cases obviate the need for diagnostic or therapeutic surgery or in vitro fertilization in vitro fertilization (vē`trō, vĭ`trō), technique for conception of a human embryo outside the mother's body. Several ova, or eggs, are removed from the mother's body and placed in special laboratory culture dishes (Petri dishes);  and the attendant cost and morbidity. During the quarter, Conceptus also commenced its Center of Excellence program in the US as part of its market development strategy to build clinical acceptance for the practice of Falloposcopy . The Company is in discussions with potential distribution partners for STARRT in Europe.

During the first quarter of 1998, the Company evaluated several centers for expansion of its Phase II study of the S/TOP (Selective Tubal Tubal (t`bəl), in the Bible, son of Japheth.  Occlusion Procedure) for permanent contraception. A single-center Phase II study, designed to evaluate device effectiveness, commenced in 1997. In another clinical study of the S/TOP device in pre-hysterectomy patients, the Company evaluated all cases performed to date and found that the procedure was well tolerated by awake, mildly sedated patients. In addition, in the first five cases, Conceptus's histological evaluation of fallopian tube fallopian tube (fəlō`pēən), either of a pair of tubes extending from the uterus to the paired ovaries in the human female, also called oviducts, technically known as the uterine tube.  tissue yielded early evidence of a local tissue response to the device, as well as damage to the tubal architecture, which is expected to be unfavorable to conception.

The transfer of manufacturing technology and know-how for products developed from Microgyn technology, including the ERA and FUTURA Resectoscope Sleeves, was completed in 1Q98. In addition, the Company introduced four new models of the ERA Resect resect /re·sect/ (-sekt´) to excise part or all of an organ or other structure.

re·sect
v.
To perform a resection on a part of the body.
 oscope sleeve to the Interventional Gynecology market. In January, Conceptus received ISO (1) See ISO speed.

(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI.
 certification and is authorized to affix affix v. 1) to attach something to real estate in a permanent way, including planting trees and shrubs, constructing a building, or adding to existing improvements.  the CE mark to its marketable products, a requirement in order to market medical devices in European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the

European Community
 member countries after June, 1998.

Conceptus, Inc. designs, develops and markets innovative interventional medical devices for use in reproductive medicine. The Company's initial focus is on the development of systems to improve the diagnosis and treatment of fallopian tube diseases and disorders, a primary cause of infertility. The Company is also introducing the ERA(tm) Resectoscope Sleeve, a novel technology designed to improve the safety and ease-of-use of therapeutic hysteroscopy, a growing, less-invasive alternative to hysterectomy hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries . The Company is in Phase II clinical trials of a non-surgical approach to fallopian tube sterilization, the most commonly performed contraceptive procedure worldwide.

Except for the historical information contained herein, the matters discussed in this press are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory approvals, results of product development programs, clinical efficacy of and market demand for products, among other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors within Conceptus's control, such as strategic planning decisions by management and re-allocation of internal resources, or on factors outside of Conceptus's control, such as delays by regulatory authorities, scientific advances by Conceptus or third parties and introduction of competitive products, as well as those factors set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 1997, the Company's prospectus dated February 1, 1996, under the heading "Risk Factors" and the Company's other filings with the Securities and Exchange Commission. -0-

                            CONCEPTUS, INC.
                     (A development stage company)
                       STATEMENTS OF OPERATIONS
             (In thousands of dollars, except share data)
                              (unaudited)

                                              Three Months Ended
                                         -----------------------------
                                         March 31, Dec. 31, March 31,
                                           1998      1997      1997
                                         -----------------------------

Net sales                               $   167    $   415    $   277

Cost of sales                               836      1,760        442
                                        -------    -------    -------

Gross loss                                 (669)    (1,345)      (165)

Operating expenses:
    R&D and regulatory                    1,386      1,309      1,431
    Sales and marketing                     879        986        803
    General and administrative              898        684        889
                                        -------    -------    -------
    Total operating expenses              3,163      2,979      3,123
                                        -------    -------    -------

Operating loss                           (3,832)    (4,324)    (3,288)

Interest income & other, net                376        345        492
                                        -------    -------    -------

Net loss                                $(3,456)   $(3,979)   $(2,796)
                                        =======    =======    =======

Net loss per share                      $ (0.36)   $ (0.42)   $ (0.30)
                                        =======    =======    =======

Shares used in computing
    net loss per share                    9,503      9,484      9,226
                                        =======    =======    =======


                     Condensed Balance Sheet Data
                            (In thousands)

                                       March 31,     December 31,
                                         1998           1997
                                     -------------- -------------
                                       (Unaudited)       (a)

Cash, cash equivalents and
 short term investments                  $ 23,240    $ 27,058
Inventory                                     327         355
Trade accounts receivable                     499         540
Total current assets                       24,385      28,243
PP&E, net                                   1,430       1,090
Total assets                               25,943      29,480

Accounts payable & accruals                 1,439       1,504
Total current liabilities                   1,551       1,635
Accumulated deficit                       (39,187)    (35,731)
Stockholders' equity                       24,076      27,504

(a) Derived from audited financial statements.





CONTACT: Conceptus, Inc.

Kathryn Tunstall or Sanford Fitch, 650/802-7240
COPYRIGHT 1998 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
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