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CONCEPTUS REPORTS SECOND QUARTER AND SIX MONTHS FINANCIAL RESULTS.


SAN CARLOS San Carlos (săn kär`lōs), residential city (1990 pop. 26,167), San Mateo co., W Calif.; inc. 1925. The chief manufactures are plastic products, hardware, and machine parts. , Calif.--(BUSINESS WIRE)--July 29, 1996--Conceptus, Inc. (Nasdaq: 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
) announced today the financial results for the second quarter and six months ended June 30, 1996.

The Company reported a net loss of $1,629,000, or $0.18 supplemental loss per share, on revenues of $105,000. This is compared to a loss of $1,306,000, or $0.30 supplemental loss per share, on revenues of $27,000 for the comparable quarter of 1995. For the six months ended June 30, 1996, the Company reported a net loss of $3,094,000, or $0.37 supplemental loss per share, on revenues of $187,000. This is compared to a loss of $2,514,000, or $0.63 supplemental loss per share, on revenues of $126,000 for the same period last year.

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.  also announced, as part of its distribution strategy, that it has entered into a distribution agreement with Mallinckrodt Medical (NYSE NYSE

See: New York Stock Exchange
: MKG MkG Mit Kameradschaftlichen Grüßen (German: With Best Regards)
MKG Mitsubishi Kreditbank GMBH (German branch of Mitsubishi Bank)
MKG Muskegon, MI, USA - Muskegon County International Airport
), a leader in the hospital radiology market. Under the terms of the agreement, Mallinckrodt Medical's direct sales force and other channels will exclusively market and distribute Conceptus's Transcervical Tubal Tubal (t`bəl), in the Bible, son of Japheth.  Access Catheter (T-TAC T-TAC Transcervical tubal access catheter system Gynecology A system used to diagnose proximal tubal occlusion, for hysterosalpingography, laparoscopic chromopertubation, and intrauterine insemination. See Ectopic pregnancy. ) system for diagnosis of proximal 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.  occlusion occlusion /oc·clu·sion/ (o-kloo´zhun)
1. obstruction.

2. the trapping of a liquid or gas within cavities in a solid or on its surface.

3.
 to hospital centers in North, Central and South America. Conceptus retains the right to sell the T-TAC system in these markets to other medical facilities and physicians. Disorders of 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.
 are a major cause of infertility.

"Mallinckrodt Medical's strength in the hospital-based radiology segment is very complimentary to our focus on the office-based interventional gynecologist gynecologist /gy·ne·col·o·gist/ (-kol´ah-jist) a person skilled in gynecology.

gy·ne·col·o·gist
n.
A physician specializing in gynecology.
," said James Messemer, Conceptus's Vice President of Worldwide Sales.

In June, Conceptus announced it had signed a marketing agreement with Schering Health Care Limited to market and distribute, in the U.K., the Company's complete line of infertility products. Schering Health Care Limited, the U.K. subsidiary of the international pharmaceutical company, Schering A.G., is the leading supplier of oral contraceptives Oral Contraceptives Definition

Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills.
 and diagnostic imaging agents in Europe.

"With the strength of our marketing partners, Mallinckrodt Medical in the Americas and Schering Health Care Limited in the U.K., Conceptus continues to make significant progress toward developing a world class distribution channel in reproductive medicine," said Kathryn Tunstall, Conceptus's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. .

Company Update

In July, Conceptus brought to trial in Europe and Australia the STARRT (Selective Tubal Assessment to Refine Reproductive Therapy) falloposcopy system which incorporates a newly developed distal tip, designed to facilitate improved imaging of the fallopian tube. The STARRT system, which was presented at the twelfth meeting of the European Society of Human Reproduction and Embryology The European Society of Human Reproduction and Embryology (ESHRE) was created in 1985 by both Professor R.G. Edwards from Cambridge, and Dr. J. Cohen from Paris, who felt that the study and research in the field of reproduction needed to be encouraged and recognized.  (ESHRE ESHRE European Society of Human Reproduction and Embryology ) in Maastricht, the Netherlands, utilizes Conceptus's T-TAC system to deploy a microendoscope to directly image fallopian tube morphology and pathology.

During the ESHRE meeting, Dr. Stefan Rimbach of the University of Heidelberg reported on over 300 falloposcopy cases performed with Conceptus's first generation falloposcopy system in the International Multicenter Study of Falloposcopy (IMSF IMSF IS-41 Message Security Forum
IMSF Intersystem Messaging Security Forum
). Dr. Rimbach, the scientific director of the study, reported that in over 60% of the IMSF cases, falloposcopy provided information unobtainable by conventional methods of tubal diagnosis. The difficulty in accurately diagnosing infertility is widely believed to be a cause of disappointing outcomes in infertility therapy.

In July, Conceptus also announced the refiling with the U.S. Food and Drug Administration (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.
) of its 510(k) application for a limited diagnostic indication of its Fallopian Tube Catheterization catheterization

Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages.
 with Microendoscopy (FTCM FTCM Formation Toward Christian Ministry
FTCM Master Chief Fire Control Technician (Naval Rating)
FTCM First Tennessee Capital Markets
FTCM Foundation for Traditional Chinese Medecine
) system. No response to the 510(k) application has been received from the FDA, but the Company remains confident that the 510(k) application process is appropriate for this clinical indication of FTCM.

The Company advanced its clinical feasibility studies of the S/TOP (Selective Tubal Occlusion Procedure) system, completing 22 cases to date. The S/TOP system is designed to provide non-surgical, permanent female contraception (sterilization sterilization

Any surgical procedure intended to end fertility permanently (see contraception). Such operations remove or interrupt the anatomical pathways through which the cells involved in fertilization travel (see reproductive system).
), utilizing Conceptus's unique fallopian tube access technology and a specially designed microcoil tubal occlusion device. The Phase I study has demonstrated the ability to successfully place the S/TOP device in the fallopian tube and has resulted in no adverse events. Key design modifications have been identified and are in development for the next phase of feasibility studies. In a parallel path, an expanded Phase I feasibility study has been approved by FDA to study the placement of the microcoil devices using fluoroscopic Fluoroscopic (fluoroscopy)
An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations.

Mentioned in: Hypotonic Duodenography
 visualization in addition to the hysteroscopic visualization already being studied. "We believe that the use of multiple visualization techniques would add even more versatility in the delivery of the device," said Julian Nikolchev, Conceptus's Vice President of Research & Development and Business Development. Subject to successful and timely completion of the Phase I study and FDA approval of Conceptus's investigational application, planned to be filed in the fourth quarter of 1996, Conceptus intends to commence Phase II efficacy studies in 1997.

"The progress in two key research and development programs, our S/TOP female sterilization Female sterilization
The process of permanently ending a woman's ability to conceive by tying off or cutting apart the Fallopian tubes.

Mentioned in: Tubal Ligation
 and STARRT falloposcopy projects are key to Conceptus's future success. These projects address two major clinical problems in reproductive medicine: infertility and the critical need for a highly reliable, non-surgical method of permanent contraception," said Lee Blumenfeld, M.D., Conceptus's Vice President of Marketing and Market Development.

Conceptus, Inc. designs, develops and markets innovative medical devices that provide minimally invasive access to the female reproductive system reproductive system, in animals, the anatomical organs concerned with production of offspring. In humans and other mammals the female reproductive system produces the female reproductive cells (the eggs, or ova) and contains an organ in which development of the fetus . The Company's initial focus is on the development of systems to improve the diagnosis and treatment of fallopian tube diseases. The Company is also developing a non-surgical approach to fallopian tube sterilization, the most commonly performed contraceptive procedure worldwide.

Except for historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory approvals, 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 prospectus dated February 1, 1996, under the heading "Risk Factors." -0-
                                     CONCEPTUS, INC.
                               (A development stage company)
                                 STATEMENTS OF OPERATIONS
                     (In thousands of dollars, except per share data)
                                        (unaudited)


                          Three Months Ended      Six Months Ended
                              June 30,                June 30,
                         1996         1995        1996         1995


Net sales             $   105       $   27     $   187      $   126
Cost of sales             235          144         394          436
Gross Margin             (130)        (117)       (207)        (310)
Operating Expenses:
   R&D and regulatory     915          627       1,703        1,155
   Sales and marketing    742          426       1,347          732
   General and
    administrative        458          222         845          448
   Total operating
    expenses            2,115        1,275       3,895        2,335


Operating loss         (2,245)      (1,392)     (4,102)      (2,645)
Interest income &
 other, net               616           86       1,008          131


Net loss           $   (1,629)     $(1,306)    $(3,094)     $(2,514)


Supplemental net
 loss per share    $    (0.18)     $ (0.30)    $ (0.37)     $ (0.63)


Shares used in
 computing
 supplemental net
 loss per share         9,127        4,330       8,382        4,004




                          Condensed Balance Sheet Data
                                 (In thousands)




                                       June 30,       December 31,
                                        1996             1995
                                     (Unaudited)




Cash, cash equivalents and short
  term investments                      46,275           5,082
Inventory                                   95              54
Trade accounts receivable                   69              13
Total currents assets                   46,637           5,599
PP&E, net                                  517             468
Total assets                            47,176           6,092
Accounts payable & accruals              1,103           1,029
Current portion of debt                    156             163
Total current liabilities                1,259           1,192
Long term portion of debt                   80             153
Redeemable convertible preferred stock      --          16,624
Accumulated deficit                    (15,075)        (11,981)
Stockholders' equity (net capital
 deficiency)                            45,837         (11,877)


CONTACT: Sanford Fitch or Burns McClellan, Inc.

Chief Financial Officer Ruth Markowitz (investors)

Conceptus, Inc. Justin Jackson (media)

(415) 802-7240 (212) 505-1919
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Jul 29, 1996
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