Conceptus will target physicians comfortable with new technology adoption through a co-promotional agreement with Johnson & Johnson/Gynecare.

Under the pact, Gynecare's 80 sales reps will market Conceptus' Essure non-incisional permanent birth control method to physicians performing endometrial ablation for menorrhagia with Gynecare's ThermaChoice uterine balloon therapy system.

Conceptus has filed a PMA supplement for marketing and labeling claims concerning the safety of using Essure and ThermaChoice in the same patient, and expects to receive approval by the end of Q1 2004.

Because endometrial ablation weakens the lining of the uterus, women electing the procedure are advised not to have any more children, making Essure a viable treatment option and alternative to tubal ligation. Both ThermaChoice and Essure can be performed within 30 minutes in the outpatient setting.

Over 200,000 endometrial ablation procedures are performed annually in the U.S., and the market is estimated to be growing in excess of 10%, according to Conceptus.

"It's a great market niche for us to be entering," Conceptus President & CEO Mark Sieczkarek stated Dec. 11 at the Harris Nesbitt Gerard Health Care Conference in New York.

Because this "physician group...already understands and recently has experienced new technology," they will be more receptive to using the Essure procedure, according to Sieczkarek.

The exec acknowledged that "physician skepticism" has hindered the product's adoption - despite strong safety and efficacy data, and a 99.8% success rate in preventing pregnancies after three years in over 10,000 implantations worldwide.

"Whenever you have a new medical technology, no matter how advanced it is, how effective, how safe, there is always skepticism, and it has to be overcome," Sieczkarek maintained.

To help drive product acceptance, the firm has published five peer-reviewed articles this year.

Essure was approved in November 2002, three months after receiving a stellar FDA panel review (¹ Also see "Conceptus Essure Contraceptive Approved Three Months Post-Panel Review" - Medtech Insight, 11 November, 2002., p. 16).

Furthermore, physicians versed in endometrial ablation procedures can use their experience in overcoming reimbursement hurdles to help secure coverage and payment for Essure, Sieczkarek posited. The CEO admitted that establishing reimbursement has been challenging, though the firm has been successful in obtaining reimbursement for 136 mil. covered entities and Medicaid patients.

One factor that could drive reimbursement acceptance is the lower cost of Essure compared with tubal ligation: an Essure procedure varies from $1,500-$2,500, while tubal ligation costs fall between $2,000-$6,000, according to Sieczkarek.

The agreement with Gynecare further will enable Conceptus to propel physician and consumer awareness of the procedure and lower training costs, Sieczkarek maintained.

"It's basically difficult, as a small company, to invest in programs where we could not see tangible revenue results for many months," Sieczkarek contended. "Al-though we created tangible consumer awareness, it was difficult to sustain...the expense that [was] required."

"The alliance with J&J solved a lot of those issues for us, in terms of creating awareness [and] consumer demand for the product and by putting 80 people basically on the street," the CEO added.

Conceptus' 20 sales reps and 13 trainers will continue to train physicians. "We're comfortably on track to have over 700 physicians on board," Sieczkarek stated.

Under the terms of the deal, announced Oct. 30, Conceptus will pay Gynecare an undisclosed fee for physician training and a commission on sales. "That fee is certainly a lot less than we could train the physician for, just given their critical mass and their organization across the U.S.," Sieczkarek noted.

Sieczkarek also emphasized the advantages of Essure over tubal ligation, including a shorter procedure time and recovery period, a lack of incisions and general anesthesia and reduced complications. Conceptus' long-term goal is to have Essure become the standard of care for permanent birth control.

Conceptus, J&J/Gynecare Agreement Will Aid Essure Adoption – CEO

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