Products in Development: Breast Check Devices
Adhesion Barriers Present an Emerging Market Opportunity
Adhesions occur after abdominal surgery in more than 60 percent of surgical cases. Approximately 30 percent are symptomatic and can cause pelvic pain, bowel obstruction, and infertility. In 1995 alone $2 billion was spent to treat patients who had adhesions.
There are several companies, as shown in Figure 1 who have or are in the midst of developing adhesion barrier products.
Figure 1
Adhesion Barrier Market Competitors (U.S.),
1997
| Company | Product | Status |
| Anika Therapeutics | INSERT | Preclinical |
| Biomatrix | Hylagel R | Pilot study |
| Ethicon | Interceed | Marketed |
| Genzyme | Seprafilm | Marketed |
| Sepragel | Phase I | |
| Gliatech | Adcon | Marketed* |
| Lifecore Biomedical | Intergel | PMA filing 6/98 |
| * Europe only | ||
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Source: Frost & Sullivan |
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Seprafilm, marketed by Genzyme, and Interceed, marketed by Ethicon, have met with some success but are performing below expectations.
In addition to improving ease of use, companies developing product need to demonstrate the product prevents the occurrence of other post-op complications such as bowel obstruction in order to receive widespread adoption by the general surgeon. Until now, most studies have focused on simply demonstrating reduction in adhesions.
Ethicon
Ethicon currently markets Interceed, which was introduced to the market 2 years ago. The product is used mainly for gynecologic laparoscopy procedures and has not met with much success because the product does not work when exposed to blood, which limits its application potential. Ethicon is investing Lifecore, however, another company developing an adhesion barrier.
Genzyme
Genzyme markets Seprafilm, a membrane which is designed to be placed or wrapped around tissues and becomes a gel which clears in approximately 7 days. The product showed 51 percent efficacy versus control group efficacy of 6 percent.
Sepracoat, an antiscarring product intended to be used in conjunction with Seprafilm, was rejected by an FDA advisory panel because it did not demonstrate efficacy on its own.
Genzyme is in Phase I clinical trials for Sepragel, a product which if efficacious, could be more highly adopted than Seprafilm because of its potential ease of use.
Lifecore
Intergel Adhesion Prevention Solution is a product developed by Lifecore that is near marketing stage. The company recently completed analysis of results from a blinded human clinical trial of 200 female abdominal surgery patients which indicated that Intergel Solution reduced incidence, extent and severity of adhesions 45 percent when compared to standard placebo-controlled treatment. The company expects to file its PMA in June of 1998 and anticipates European sales in June of 1998 as well. Ethicon has exclusive worldwide marketing rights to Interceed.
Market Potential
If products in development are easy to use and cost-effective, the adhesion barrier market could be a significant market opportunity. Adoption of the product will depend on the price. The market appears to be very inelastic; if prices are high (i.e. in the current price range of $300-$400), there will be very little adoption. If the price is low (i.e. $10), the penetration will be very high (i.e. become routinely used in nearly all procedures).