Conceptus Reports Third Quarter Financial Results; Company Accelerates Planned PMA Submission.

Business Editors & Health/Medical Writers

SAN CARLOS, Calif.--(BW HealthWire)--Oct. 24, 2001

Essure(TM)pbc Specialists in Australia Reported 60% of Their Permanent

Birth Control Practice Converted to the Essure pbc Procedure

Conceptus, Inc. (Nasdaq:CPTS), developer of the non-incisional permanent birth control procedure Essure(TM)pbc, today announced financial results for the three and nine months ended September 30, 2001.

For the third quarter of 2001, the Company reported a net loss of $4.5 million, or $0.33 per share, compared with a net loss of $3.7 million, or $0.33 per share, in the comparable period last year. Sales for the third quarter of 2001, a majority of which were derived from Australia, were $123,000, compared with no sales in the prior-year third quarter. Cost of sales for the third quarter of 2001 was $537,000. Research and development expenses were $2.0 million for the 2001 third quarter, compared with $2.6 million in the 2000 third quarter when the company was incurring expenses related to the U.S. pivotal trial for Essure pbc. Selling, general and administrative expenses in the third quarter increased to $2.2 million from $1.3 million in 2000 largely related to sales and marketing activities as the Company recorded its second consecutive quarter of commercial sales of Essure pbc.

For the nine months ended September 30, 2001, Conceptus posted a net loss of $12.8 million, or $0.99 per share, compared with a net loss of $8.3 million, or $0.82 per share, for the nine months ended September 30, 2000. The increase in net loss was primarily due to increased sales and marketing efforts, including professional training and awareness programs.

Cash, cash equivalents and short-term investments as of September 30, 2001 were $8.8 million, compared with $12.5 million as of December 31, 2000.

"During the quarter, we made significant progress toward achievement of our most important objective: acceleration of U.S. regulatory approval of Essure pbc," commented Steven Bacich, chief executive officer. "As a result of the strength of our current clinical data, we plan to submit our Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) by the end of the second quarter of 2002, instead of the third quarter as previously scheduled. The first module of our PMA is now scheduled for submission in the coming weeks. We have accumulated more than 575 woman-years of effectiveness data between our Phase II and Pivotal clinical trials, with no pregnancies. Statistical analysis of this interim data support a current effectiveness rate of 99.8% for Essure pbc, although I caution that no method of birth control can be expected to be 100% effective, including Essure pbc. It should also be noted that the trial is ongoing and that additional follow-up data will be required to establish a one-year effectiveness rate to support the PMA."

Mr. Bacich continued, "The ongoing launch in Australia is a key effort for Conceptus. Australia is admittedly a small market compared to the United States, but directly marketing Essure pbc in Australia affords us the opportunity to test many of our planned sales, reimbursement and clinical training strategies. We have learned much that will be valuable as we introduce Essure pbc in other parts of the world. For example, after having generated significant consumer interest in Essure pbc through patient-directed public relations, during the quarter we focused resources on building a knowledge base about Essure pbc among general practitioners (GP), who serve as gatekeepers for patient referrals to gynecologists, while continuing to train gynecology specialists to perform the Essure pbc procedure. To date, we have trained 90 gynecologists at more than 25 centers in Australia. We are seeing evidence that our GP education efforts have been accelerating patient referrals to our trained specialists. And with our surveyed specialists, already approximately 60% of their permanent birth control practice has converted to the Essure pbc procedure. We feel comfortable that we have educated a sufficient number of general practitioners to resume our direct-to-consumer efforts, which began on October 14th. We are very encouraged by the response to our call center thus far," stated Mr. Bacich.

In commenting on marketing plans for Europe, Mr. Bacich said, "We expect to have a decision on European marketing and distribution shortly. Our reimbursement studies are underway in this region and we have hired Yves Guillemain d'Echon, who will be responsible for our European distributor and corporate partner relations. Mr. Guillemain d'Echon is an experienced medical device industry executive who most recently was the President of Europe for Sofamor Danek Medtronic."

Conceptus has scheduled an investor conference call to discuss this announcement beginning at 4:30 p.m. Eastern Time today. Individuals interested in listening to the live conference call via the Internet may do so by logging on to the Company's Website, www.conceptus.com. A replay will be available on the Website for 30 days.

Permanent Birth Control

Surgical tubal ligation has become the most common form of birth control worldwide, despite the fact that it is invasive and costly. About 93% of the procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, requiring between four to five hours of hospital recovery time and an average of three to ten days before returning to regular activities. An Essure pbc procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. Accordingly, a woman is expected to spend about two to three hours of her day for an Essure pbc procedure, and to have a rapid return to regular activities. Reliance on Essure pbc does not involve taking drugs or hormones, which can interfere with the body's natural menstruation cycle.

About Conceptus

Conceptus, Inc. is developing Essure pbc, an investigational medical device and procedure in the U.S., which is designed to provide a non-incisional alternative to tubal ligation, the leading form of contraception worldwide. Data from the United Nations show that worldwide, 33% of reproductive couples using contraception rely on surgical tubal ligation. Additionally, a survey performed by the United States Centers for Disease Control and Prevention indicates that surgical tubal ligation continues to be the most prevalent form of contraception in the United States, and that 35% of women age 35-44 have had a surgical tubal sterilization. An estimated 700,000 surgical tubal ligations are performed each year in the United States.

The Essure pbc procedure is based on a unique and proprietary catheter delivery system for minimally invasive transcervical tubal access. Additional information about Conceptus and the Essure pbc procedure is available at www.conceptus.com.

Except for the 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, results of product development programs, and clinical efficacy of and market demand for our product, 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 the Company's control, such as strategic planning decisions by management and re-allocation of internal resources, or on factors outside of the Company's control, such as delays by regulatory authorities, scientific advances by 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, 2000 and other filings with the Securities and Exchange Commission.

                           Conceptus, Inc.
                        Statement of Operations
                              (Unaudited)
               (In thousands, except per share amounts)

                             Three Months Ended     Nine Months Ended
                                September 30,         September 30,
                               2001      2000         2001      2000

Net Sales                  $    123   $      -   $      286  $      -
Operating expenses:
 Cost of sales                  537          -        1,183         -
 Research and development     1,953      2,644        5,818     6,030
 Selling, general and
  administrative              2,234      1,274        6,631     3,239
Total operating expenses      4,724      3,918       13,632     9,269
Operating loss               (4,601)    (3,918)     (13,346)   (9,269)
Recovery of legal defense
 costs                            -         -             -       513
Interest and other income,
 net                            143        263          545       452
Net loss                   $ (4,458)  $ (3,655)   $ (12,801) $ (8,304)
Basic and diluted net loss
 per share                 $  (0.33)  $  (0.33)   $   (0.99) $  (0.82)
Shares used in computing
 basic and diluted net
 loss per share              13,712     11,163       12,920    10,182


                            Conceptus, Inc.
                             Balance Sheet
                            (In thousands)


                                       Sept 30,           December 31,
                                         2001                2000
                                      (Unaudited)            (a)

Cash, cash equivalents and short-term
 investments                          $  8,835            $  12,493
Accounts receivable                        150                   -
Inventory                                  937                   67
Other current assets                       207                   59
Total current assets                    10,129               12,619
Property and equipment, net              1,587                1,153
Other assets                               395                  334
Total assets                          $ 12,111             $ 14,106
Accounts payable and accruals            3,385                4,147
Common stock                            88,678               77,107
Accumulated deficit                    (79,952)             (67,148)
Stockholders' equity                     8,726                9,959
Total liabilities and stockholders'
 equity                               $ 12,111             $ 14,106


(a) Derived from audited financial statements.