Conceptus, Inc. – bringing change to a market that hasn’t seen change in 30 to 40 years with the ESSURE PBC™ a permanent contraceptive for women

Healthcare
Medical Equipment
NASD: CCEL

Conceptus, Inc.

1021 Howard Ave.
San Carlos, CA 94070



Steven Bacich
President and
Chief Executive Officer

Interview conducted by:
Walter Banks, Co-Publisher

CEOCFOinterviews,com
August 2001

 

Biography – Steven Bacich, President/CEO

Mr. Bacich was promoted to President and CEO and was elected a director in January 2000.  Mr. Bacich joined Conceptus in March 1997 as Vice President, Research and Development.  Prior to joining Conceptus, Mr. Bacich spent seven years as a Co-founder and Director of New Product Development for Imagyn Medical, Inc., a medical device manufacturer of gynecological products for infertility and endoscopic procedures.  From August 1987 to September 1989, Mr. Bacich held engineering positions in research and development most recently as Senior Staff Engineer, Business Development for the Edwards Less Invasive Surgery Division of Baxter.  From 1985 to 1987, Mr. Bacich held research and development positions at Mentor Corporation, a reconstructive surgery and urology company.  From 1983 to 1985, Mr. Bacich held research and development positions at American Medical Optics, an ophthalmic medical device manufacturer and Division of American Hospital Supply Corporation.  Mr. Bacich holds a B.S. in Biomedical Engineering from the University of California, San Diego.

About Conceptus, Inc.

Conceptus, Inc. was formed in September 1992, and has been primarily engaged in the design, development and marketing of innovative interventional medical devices for use in reproductive medicine. The Company's focus is on the development of its Essure pbc™ non-surgical permanent contraception device for women.

Essure pbc is designed to provide permanent contraception 

• Requires no incisions
• Can be performed in a doctor's office in 15-20 minutes
• Does not require general anesthesia
• No abdominal scars to heal
• Contains no drugs

CEOCFOinterviews - Mr. Bacich, can you give us a brief history of Conceptus? 

Mr. Bacich: "Conceptus was spun out of Target Therapeutics in 1992 and then it went public on an infertility platform.  In the year of 1998, the company was restructured and reorganized to focus on an R&D clinical program that it had in its own department. It sought out to provide women an alternative to surgical tubal ligation, the most prevalent form of birth control in the United States. There are more women of a reproductive age that have been sterilized via tubal ligation than those using oral contraceptives or condoms, the main contraceptives. On the premise of the 13 million procedures being performed annually in the United States and worldwide, the company refocused on the sterility market utilizing the technology that will provide the product, which is delivered trans-vaginally through the cervix into a woman's fallopian tubes.

A unique aspect is that a woman can observe the procedure on a video monitor with the doctor. A little local anesthetic is typically required at the cervix. The procedure is done in less than 20 minutes and then the woman is free to get up and continue with her day. Compare this to the standard of care, which is tubal ligation and requires general anesthetic, abdominal incision or puncture, 4-5 hours in the recovery room and three to ten days before women can return to normal activities. We announced on July 11 that within our pivotal trial that 92% of the women who worked in our trial returned to work in one day or less. That is a remarkable contrast to the option available to women. Women are really looking for options. Right now our biggest market segment are couples that spend their time around the dining room table discussing who is going to take over the contraceptive family planning for them. A unique dynamic goes between the male and female. The men resist having a vasectomy and more often than not, the contraceptive care of the family falls to the woman. The resort is surgical tubal ligation."

CEOCFOinterviews – What is the name of your product?

Mr. Bacich: "The name of the product is Essure pbc™. Previously, throughout the development stage it was known as Stop. Now that we are marketing it directly in Australia and Singapore and very shortly in Europe since we have our C.E. mark, we went out and tested names. Essure pbc™ came out the strongest, rated very highly by women, not only because it is far more feminine but because it conveys a theme of reliability and dependability and that is what our global name is.”

CEOCFOinterviews - Can the procedure be reversed?

Mr. Bacich: "Just like a tubal ligation or vasectomy, it is not intended to be reversed. These are permanent procedures and we believe that ours is irreversible as well.”  

CEOCFOinterviews – What stage are you in the development of your product in the United States?

Mr. Bacich: "In the United States we went through three phases of testing; one, two and the pivotal trial. We have completed our four hundredth patient enrollment in December of the year 2000.  Currently we are in the follow-up period of our pivotal trial. Roughly, a one-year follow-up is required. We anticipate third quarter 2002 to be the time when the FDA is going to be reviewing all of our data and we are looking to a mid-year 2003 market release. In the meantime we will be focusing on the international market, a with procedure that is performed all over the world."

CEOCFOinterviews - How has the response been in the international market?

To receive a complete copy of this interview call: 570-839-0236