Conceptus Announces Re-Filing of 510k Application for Marketing Clearance with the U.S. Food & Drug Administration.

SAN CARLOS, Calif.--(BUSINESS WIRE)--July 10, 1996--Conceptus, Inc., (NASDAQ: CPTS) announced that it re-filed its 510(k) application on June 28, 1996, with updated clinical data, for its Fallopian Tube Catheterization with Microendoscopy (FTCM) system for a limited diagnostic indication.

The original 510(k) application for this indication was filed with the Food and Drug Administration (FDA) in October 1995 and was automatically withdrawn by FDA in January 1996 because the deficiencies cited were believed to require more than thirty days to address. The most significant issue was a request for additional clinical data. The company was instructed to submit the additional clinical data in a re-filed 510(k) application, which it has now done.

"The FTCM is yet another application of our platform Transcervical Tubal Access Catheter technology," said Dr. Lee Blumenfeld, Vice President of Marketing at Conceptus, Inc. Conceptus's technology was originally developed by Target Therapeutics, Inc. for accessing, diagnosing and treating diseases involving the delicate blood vessels of the brain. Dr. Blumenfeld continued, "Also effective in the reproductive system, our proprietary catheter technology enables physicians to nonsurgically access the fallopian tubes and, combined with a proprietary micro-endoscope which is less than 0.50 mm in diameter, is designed to improve the accuracy of tubal diagnosis through direct imaging."

Previously, in 1995, Conceptus received 510(k) FDA marketing clearance for its Transcervical Tubal Access Catheter system (T-TAC) for the diagnosis of proximal tubal occlusion (PTO) which may contribute to infertility, for use in conjunction with hysterosalpingography (HSG) the most frequently used procedure for diagnosis, for use in laproscopic chromopertubation (lap and dye) another widely used diagnostic procedure, and for intrauterine insemination.

Fallopian tube disorders are a major cause of infertility; over 35% or female infertility in the United States is attributable in whole or part to Fallopian tube disorders (Source: American Society of Reproductive Medicine). The ability to definitively diagnose tubal disorders often leads to unnecessary, costly and invasive treatment, such as open tubal surgery and in-vitro fertilization with embryo transfer (IVF). Equally important, inaccurate infertility diagnosis may delay the delivery of appropriate treatment, a major problem for those women whose fertility status is already compromised by age.

"As with all medical device applications, before an FDA review of a 510(k) application is completed, FDA may decide that a Pre-Market Approval Application (PMA) and/or additional clinical data, not currently available, will be required for marketing clearance. However, we continue to believe that the 510(k) application process is appropriate for this clinical indication of FTCM," said Kathryn Tunstall, President and CEO of Conceptus.

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, 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."

Conceptus, Inc. designs, develops and markets innovative medical devices that provide minimally invasive access to the female reproductive system. 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 a developing a non-surgical approach to Fallopian tube sterilization, the most commonly performed contraceptive procedure worldwide.

CONTACT: Conceptus, Inc.

Kathryn Tunstall/Sanford Fitch, 415/802-7240

or

Burns McClellan, Inc.

Justin Jackson/Reagan Codner, 212/505-1919