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CONCEPTUS, INC. RECEIVES FDA CLEARANCE FOR TRANSCERVICAL FALLOPIAN TUBE CATHETERIZATION

Fourth 510(k) Clearance of 1995 the Most Important to Date
 Third Round of Private Financing Completed in June 1995


SAN CARLOS, Calif., Aug. 3 /PRNewswire/ -- Conceptus, Inc. today announced it has received the US Food and Drug Administration (FDA) clearance to market a system of microcatheters and guidewires for transcervical fallopian tube catheterization. This will enable physicians to enter the fallopian tubes through the cervix in order to more accurately and directly diagnose tubal disorders. Until now, physicians only had available non-selective, radiologic diagnostic procedures which were known to be highly inaccurate in diagnosing tubal disorders.

Infertility affects nearly one out of every five couples and is over a $2 billion annual industry in the United States. Yet in 1993 (the last year data is available), only 1.5 million infertile couples sought treatment and fallopian tube disorders were the cause of 35% of female infertility. Using transcervical fallopian tube catheterization to improve the accuracy of diagnosis of tubal health and patency can obviate the need for diagnostic or therapeutic surgery or in vitro fertilization and the attendant cost and morbidity.

"Until now, reproductive medicine has not benefited from the extraordinary advances made in interventional catheter technology in the 1980s, which allowed physicians to treat other conditions, such as cardiovascular and neurovascular disorders, in a less invasive and highly effective manner," said Kathryn Tunstall, President and Chief Executive Officer of Conceptus, Inc. "Conceptus was formed to respond to the many requests of reproductive specialists for effective, simple and non-surgical treatment options for patients -- precisely the benefits that interventional techniques have brought to other areas of medicine."

The microcatheters and guidewires approved for transcervical fallopian tube catheterization are based upon Target Therapeutics, Inc. (Fremont, Calif.) neurovascular microcatheter technology to which Conceptus has an exclusive, worldwide license. This platform technology serves as the basis of Conceptus development plans: the Company is focused on optimizing less invasive technology from other diagnostic or therapeutic clinical areas for use in reproductive applications. Adds Ms. Tunstall, "This is the fourth, and most important, FDA clearance for transcervical reproductive applications we have received this year. It means we are one step closer to bringing to the field of reproduction a complete product line based upon the innovative, proven technologies of interventional medicine."

Several of these additional product applications are under clinical investigation in the United States, Europe and the Pacific Rim. Falloposcopy, which is the study of the pathology of the fallopian tubes using a fiber-optic endoscope, is being evaluated in a twenty center, International Multicenter Study of Falloposcopy (IMSF), directed by Dr. Stefan Rimbach of the University of Heidelberg.

Dr. Rimbach reported a 93% technical success with falloposcopy last month at a meeting of Study Investigators held during the annual meeting of the European Society for Human Reproduction and Embryology. He also reported that falloposcopy provided information not available by HSG and laparoscopic surgery, two conventional methods of diagnosing tubal disorders, in 50% and 25% of cases, respectively. Importantly, consistency of image interpretation was also reported to be similar to that found with laparoscopy, the "gold standard" diagnostic method.

Conceptus, Inc. is the first company with a singular focus on interventional gynecology. The privately-held company was founded in January 1993 with funds associated with New Enterprise Associates and Onset Enterprises. Additional investors include Catalyst Ventures, Piper Jaffray Ventures, St. Paul Ventures and SOFINNOVA. A third round of financing was completed in June 1995 which included new investors Weiss, Peck & Greer and Essex Capital along with each of the earlier investors.
 -0- 8/3/95


/CONTACT: Kathryn Tunstall of Conceptus, Inc., 415-802-7240/

CO: Conceptus Inc. ST: California IN: MTC SU: PDT

RB-LW -- SF015 -- 1712 08/03/95 21:16 EDT
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Publication:PR Newswire
Date:Aug 3, 1995
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