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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): January 3, 2001
CONCEPTUS, INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 97-3170244
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(State or Other Jurisdiction of (I.R.S. Employer Identification No.)
Incorporation)
000-27596
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(Commission File Number)
1021 Howard Avenue, San Carlos, California 94070
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(Address of Principal Executive Offices) (Zip Code)
(650) 802-7240
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(Registrant's telephone number, including area code)
N/A
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(Former Name or Former Address, if Changed Since Last Report)
ITEM 5. OTHER EVENTS.
On January 3, 2001, Conceptus, Inc. issued a press release announcing
early attainment of patient enrollment goal for STOP pivotal trial. The text of
the press release follows:
CONCEPTUS
(Logo Omitted)
Company Contacts Investor Contacts General Media Contact
Conceptus, Inc. Lippert Heilshorn & Associates Cohn & Wolfe
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Oliver Brouse, Bruce Voss ([email protected]) Lynn Kenney
Director, Finance (310) 575-4848 (212) 798-9766
[email protected] Kim Golodetz ([email protected]) Lynn_Kenney@nyc.
(650) 802-7297 (212) 838-3777 cohnwolfe.com
Stan Van Gent, Financial Media Contact
VP, Marketing Elissa Grabowski
[email protected] ([email protected])
(650) 413-1603 (212) 838-3777
www.conceptus.com www.lhai.com
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CONCEPTUS ANNOUNCES EARLY ATTAINMENT OF
PATIENT ENROLLMENT GOAL FOR STOP PIVOTAL TRIAL
Accelerates PMA Filing
Sets Milestones for International Product Launches
SAN CARLOS, Calif. (January 3, 2001) - Conceptus, Inc. (Nasdaq NM: CPTS)
announced that bilateral placement has been achieved in more than 400 patients
in the pivotal clinical study of the STOP(TM) (Selective Tubal Occlusion
Procedure) non-surgical permanent contraception device for women. The pivotal
study is designed to obtain 12-month effectiveness data on 400 patients with
bilateral placement to support a Pre-Market Approval (PMA) application.
Accordingly, the PMA application filing timeline is expected to be accelerated
by approximately three months.
Enrollment in the multi-center, international pivotal clinical trial for STOP
commenced in May of 2000. Additional patients will be enrolled over the next
several weeks to replace any patients who may be lost-to-follow-up or who cannot
be evaluated for other reasons. The pivotal trial will examine safety,
effectiveness, and patient comfort during the placement procedure and subsequent
use of the STOP device.
"The rapid enrollment we've experienced in the STOP trial highlights the desire
women have for a new permanent contraceptive option, and demonstrates the
tremendous commitment of the physicians and their staffs at all of the
investigational sites," said Jay M. Cooper, M.D., founder and medical director
of Women's Health Research Center, Phoenix, Arizona, and the principal U.S.
investigator of STOP.
"The enthusiasm of our STOP clinical investigation team coupled with targeted
advertising helped us to achieve this important milestone ahead of plan," said
Steven Bacich, president and chief executive officer of Conceptus. "Accordingly,
our expenses in the fourth quarter of 2000 will reflect this higher level of
patient enrollment."
The pivotal study protocol requires 12 months of follow-up after each patient
begins to rely exclusively on STOP for contraception, which occurs three months
after the STOP placement procedure. As such, Conceptus is working towards a PMA
filing with the FDA during the third quarter of 2002.
"Australia will be the first country where STOP is commercially available. We
have already received both Therapeutic Goods Administration listing and a
reimbursement code comparable to that of surgical tubal ligation, and we are
making excellent progress towards a product launch during the first quarter of
2001," according to Mr. Bacich. "In Australia, we will be marketing STOP
<PAGE>
ourselves, and we continue to speak with prospective co-marketing partners, as
well."
Commenting on the outlook in Europe, Conceptus expects to receive the CE Mark
from a Notified Body in the very near future. Upon receipt of the CE Mark, plans
call for conducting reimbursement studies and securing one or more partners for
sales and marketing, as well as initiating the Decentralized Mutual Recognition
procedure of the European Union, which covers 11 European countries. The first
commercial sales of STOP in select European markets are expected in 2001.
Permanent Contraception
Surgical tubal ligation has become the most common form of contraception
worldwide, despite the fact that it is invasive and costly. In the U.S., about
93% of such procedures are performed in a hospital or surgi-center under general
anesthesia, requiring 4-5 hours of hospital recovery time and resulting in 3-4
days off work. A STOP procedure does not require cutting or penetration of the
abdomen, is typically performed with local anesthetic and can be performed in a
less costly office setting. Accordingly, a woman is expected to spend about 2-3
hours of her day for a STOP procedure, with a rapid return to normal activities.
About Conceptus
Conceptus, Inc. is developing STOP, an innovative medical device and procedure
designed to provide a non-surgical alternative to tubal ligation, the leading
form of contraception worldwide. The STOP device is a unique and proprietary
micro-coil designed to be deployed permanently into each fallopian tube using
the Company's minimally invasive transcervical tubal access catheter system.
Once in place, clinical studies have shown that the STOP device induces an
occlusive tissue response.
Data from the United Nations show that worldwide, 30% of reproductive couples
using contraception rely on surgical tubal ligation. Additionally, a survey
performed by the Centers for Disease Control and Prevention indicates that
surgical tubal ligation continues to be the most prevalent form of contraception
in the U.S., and that 35% of women age 35-44 have had a surgical tubal
sterilization. An estimated 800,000 surgical tubal ligations are performed each
year in the U.S.
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 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 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,
<PAGE>
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, 1999
and other filings with the Securities and Exchange Commission.
# # #
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CONCEPTUS, INC.
(Registrant)
By: /s/ Oliver Brouse
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Oliver Brouse
Director of Finance
Dated: January 11, 2001
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