Adhesions are bands of fibrous scar tissue that form on the abdominal or pelvic organs, causing the organs to stick to one another or to the abdominal wall. Genzyme, Inc. lists adhesion disease as a reason for 49 to 74 percent of small bowel obstructions, 15 to 20 percent of infertility cases in women and 20 to 50 percent of chronic pelvic pain cases. In addition to these significant findings, experts state that a staggering 60 to 90 percent of women undergoing gynecologic surgery develop adhesions over time. These adhesions are known to cause chronic pelvic pain, infertility, urinary tract problems, sexual dysfunction, and bowel obstruction.

In the U.S., the annual cost for adhesiolysis alone is estimated to be $1.3 billion for hospital and surgeon fees. The cost for outpatient treatment of small bowel obstructions resulting from adhesions was $800 million per year in recent years.

Sawhney’s Solution

The solution, according to Amar Sawhney, CEO of Waltham, MA, basedConfluent Surgical, in layman's terms, is to utilize a “bandage for internal organs” once the surgery is complete. The medical term for this is adhesion barrier, and there are many such products either on the market or under development today. The purpose of these products is to seal the incision on the operated-upon organ and to build a barrier around the organ so that the scar tissue that causes adhesions does not develop.

Sawhney, along with co-founders Fred Khosravi and J. Milton Harris, founded the company in 1998 with the vision to go head-to-head with major names in the in-situ-polymerized biomaterials and medical device markets. The combined experience of this team has played a major role in the success of the company so far.

Sawhney is one of the inventors of the hydrogel technology which is the core of Confluent Surgical's technology platform. His inventions have formed the basis for the founding of several medical device and biotechnology companies and their products. These include, for example, the in-situ polymerized surgical sealant products that are currently being developed and marketed by Focal, Inc. (acquired by Genzyme), where he recently held the position of Director and Technology Founder. Other companies that are pursuing technologies that have been co-invented by Sawhney include Novacell, which is developing biohybrid organs for transplantation, and Infimed, Inc., which is developing controlled release systems for drug delivery.

Confluent Space

Companies marketing adhesion barrier products now include big, recognizable names: Baxter, Johnson & Johnson (Ethicon), Genzyme, and Smith & Nephews. Johnson & Johnson's Ethicon business is marketing a product called Intergel, which it has licensed from LifeCore Medical. Intergel is the most common adhesion barrier product available in the U.S. today. Developed from human or animal tissues, Intergel is based on a compound known as ferric hyaluronate and is used for open surgery.

“Intergel is this thin, goopy material,” says Larry Haimovitch, a medical technology consultant based in Mill Valley, California. “The product is competitive because it is based upon this spray device idea. The drawback is that it is not approved for laparoscopic surgeries, so it cannot be marketed as such. This is a drawback because many of the adhesion disease cases in which this product can be used are treated through laparoscopic surgery.”

Products like Intergel have some inherent issues. First, because the products are made from human or animal tissues, doctors and patients may have concerns over infectious agents like HIV, mad cow disease, and hepatitis. Second, because the products are based upon organic materials, they are expensive to manufacture and resources may run low.

The third issue is most likely to occur, according to Sawhney. “Adhesions barrier products based on natural materials often don't stick to the organs,” said Sawhney. “This is critical to the success of the product —if it doesn't stick, it won't work.”

With a staff of about 40 people, Confluent Surgical has experts in the design of medical devices (for the devices used to apply the products during surgery), polymer scientists for the development of the adhesion barrier and tissue sealant products, and staff focused on clinical trials, and regulatory and quality processes.

Confluent Products

Confluent Surgical has two products currently in different stages of marketability. The first, SprayGel™ adhesion barrier, has gone through trials in Europe and is now approved for marketing in Europe, Australia, and New Zealand. The SprayGel product is in clinical trials in the U.S. and should reach approval for marketing by the end of 2003.

The SprayGel product is the first gel-based adhesion barrier product that is applied laparoscopically. This is a major competitive differentiator, according to Haimovitch. He confirms that this is truly a first-of-its kind product.

The compound that is the basis for the product is polyethylene glycol, which is used in cosmetics, eye care products, and capsules for timed release of medications into the body. “This compound is commonly used in many products,” says Sawhney. “It works very effectively for this application.”

SprayGel is applied at the end of surgery to the area of the organ where the surgeon has operated. The gel is 90 percent water and is applied using a laparoscopic device designed by Confluent Surgical. After a short time, the gel hardens into a solid material and the doctor finishes the surgery. After a week's time, once the body has time to heal properly, the gel converts back to liquid form and is eliminated from the body through the kidneys.

The second product is called Dural Sealant, and is a tissue sealant product intended for use in open surgeries. Dural Sealant is currently in clinical trials in Europe and will most likely be used in clinical trials in the U.S. beginning by the end of this year.

From a financial perspective, the company has done well so far. Confluent Surgical is in its third round of funding: the company obtained $20 million in June of this year, purportedly to fund the finalization of the multi-center clinical trials in the U.S.

The company is now beginning to generate revenues from sales of the SprayGel product in Europe, Australia and New Zealand, and Sawhney says the company is expecting to reach $160 million in revenues by 2006, with profitability in mid-2004. Assuming the economic environment is better, Sawhney says the company may go public at the end of 2003.

Adding It All Up

The company has a number of positives on its side. According to Dr. Roger J. Ferland, a specialist in Obstetrics, Gynecology, and Endoscopic Surgery at Women's and Infants Hospital of Rhode Island, the benefits of Confluent Surgical's products are manifold. By using synthetic materials which can be produced in mass quantities cheaply, Confluent Surgical has a leg up on its competition because the material can be produced more easily and at much lower cost compared to biological materials.

The use of synthetic materials will eliminate risks inherent in using any products based on human tissues, especially with concerns over infectious agents like HIV, mad cow disease, and hepatitis. Using synthetic materials eliminates these risks.

SprayGel is an easy to apply, efficacious preventative to adhesions, which can increase the risk of post-op complications. By preventing adhesions, surgery is safer and the risk of need for re-operation due to bowel obstruction is reduced.

There are drawbacks and challenges, however. First, the approval process in the U.S. through the Food and Drug Administration is cumbersome, to say the least. Sawhney admits that the U.S. market will be the most crucial one for the success of the company: 50 to 80 percent of the worldwide market for adhesion barriers and tissue sealants comes from the U.S.

If Confluent Surgical is to succeed as a company, it needs approval in U.S. markets before funding runs out. So far, the company appears to be on steady ground in this area.

Second, the current downturn in the economy makes it difficult to obtain funding and to sustain the development of products. This has already had an impact on some of Confluent Surgical's competitors, but it has yet to become a major issue for Confluent Surgical. In fact, Sawhney counts it as a benefit that some of his competitors are “dead or dying.” He may be right.

Finally, Haimovitch says that the biggest challenge facing Confluent Surgical is the fact that many physicians will have to be sold on the idea that adhesion disease is serious enough to require a product like SprayGel for every abdominal or pelvic surgery. “Many physicians don't admit there is a problem. This is partly due to the fact that the doctor whose surgery originally caused the adhesion in the patient is not often the one who ends up treating the patient for adhesion disease later,” says Haimovitch. Haimovitch's opinion is that Confluent Surgical must embark on the major task of “educating” physicians on the need for adhesion barriers for each and every surgery.

But Ferland doesn't see this as a major issue. He says, “the people in the gynecology field feel adhesion disease is a significant issue—the data supports this—and these people will definitely go for a product like SprayGel. Once it is available in the U.S., I foresee widespread use, because the existing adhesion barrier products don't work well and are hard to apply.” If Sawhney is correct, physicians worldwide will be happy to see Confluent Surgical's products available. If the statistics are correct, patients will ultimately be the ones to benefit.