Conceptus Receives Notification of 510-k Regulatory Classification for its Falloposcopy Devices from the Food and Drug Administration.

SAN CARLOS, Calif.--(BUSINESS WIRE)--Sept. 9, 1996--Conceptus, Inc. (NASDAQ: CPTS) announced today that it received a letter from the Food and Drug Administration (FDA) regarding the regulatory classification of falloposcopes used to evaluate proximal tubal occlusion (PTO) in the fallopian tube.

The letter states that the FDA has determined that falloposcopy devices used for this indication will be reviewed for marketing through the 510(k) process instead of the more lengthy PMA process. The premarket notification, or 510(k), process requires the demonstration of "substantial equivalence" of the subject device to a legally marketed 510(k) device, and the FDA may require clinical data to support a determination of substantial equivalence. FDA's letter stated that clinical data will be required to support a 510(k) application for falloposcopy devices for this indication.

Further clarifying the requirements, FDA stated that data in the 510(k) application should support substantial equivalence of the falloposcope to selective salpingography catheters and hysteroscopes. Conceptus's selective salpingography catheters (Trade name: T-TAC) were cleared for diagnosis of PTO by FDA in 1995, via the 510(k) process. In addition, the Company also received 510(k) clearance for its diagnostic hysteroscope in early 1996.

"FDA's letter does not necessarily indicate that our pending 510(k) will be cleared, nor does it clarify whether additional clinical data will be required before clearance can be obtained," said Cindy Domescus, Vice President of Clinical Research and Regulatory Affairs at Conceptus. "However, we have strongly held that a 510(k) submission is the correct approach for this falloposcopy indication, and we are very pleased that FDA has confirmed this approach, which represents a fundamental policy change regarding the requirements for marketing falloposcopy devices for this indication."

Conceptus originally proposed to the FDA that it downclassify these devices in October of 1995, with the submission of a 510(k) application for use of its falloposcopy system in the diagnosis of PTO. After discussions with FDA regarding the deficiencies raised in the Agency's response to the original 510(k) filing, the Company re-filed its 510(k) with updated clinical data in June of 1996. This re-filed 510(k) application is currently pending Agency review at the FDA.

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. The Company is also a developing 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 release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The actual receipt of regulatory approvals and, if obtained, the timing thereof, may differ significantly from the discussion of such matters in the forward-looking statements. In addition, notwithstanding the receipt of such approvals, the clinical efficacy of and market demand for the Company's products is subject to a number of risks and uncertainties. The principle, but by no means only, risks and uncertainties applicable to the Company's products and its business in general are set forth in the Company's prospectus, dated February 1, 1996, under the heading "Risk Factors."

CONTACT: Conceptus, Inc.

Kathryn Tunstall or Sandford Fitch, 415/802-7240

or

Burns McClellan, Inc.

Justin Jackson (media) or Reagan Codner (investors),

212/505-1919