Tuesday, February 25, 2003

New tool offers help for kidney patients

By Tim Bonfield
The Cincinnati Enquirer

Four or five years from now, many of the estimated 370,000 Americans on kidney dialysis could start getting their treatment at home as a result of a contract announced Monday involving research from Cincinnati Children's Hospital Medical Center.

The licensing agreement between the hospital and BTG, a global technology company, ranks among the three biggest developments in the pipeline stemming from research at Cincinnati Children's, officials say.

The treatment: Dialysis mimics kidney function by using machines to cleanse blood of waste, salt and excess water while balancing other chemical levels.
The process: Most patients spend about four hours per session three days a week at a hospital, doctor's office or dialysis clinic. Some people have been trained well enough to do dialysis at home.
The need: About 370,000 people are currently on dialysis in the United States. A few thousand people a year stop dialysis after getting a kidney transplant. But most people stay on dialysis for the rest of their lives.
The cost: Insurers spend more than $18 billion a year on kidney dialysis. In Ohio, costs for a single dialysis patient can reach $65,000 a year.
Sources: National Kidney Foundation and Cincinnati Children's Hospital Medical Center
The project involves producing and marketing an improved type of dialysis that adjusts itself to several measures of a patient's health during a four-hour dialysis session.

If successful, the system would make home dialysis more practical by reducing the odds of human error and reducing the need for medical supervision.

"This system makes the kinds of decisions that I would make in reaction to a patient's parameters," said Dr. John Bissler, the pediatric nephrologist who led its development.

The product could be on the market within four or five years, pending availability of more miniaturized equipment and a review by the U.S. Food and Drug Administration, said Joe Fondacaro, director of intellectual property and venture development at the hospital.

The product could be available even sooner in some European countries, he said.

Officials would not reveal their estimate of the potential commercial value of the system.

But it could be significant because of the number of people on dialysis, according to the National Kidney Foundation.

Nationwide, insurers spend more than $18 billion a year on kidney dialysis. In Ohio, costs for a dialysis patient can reach $65,000 a year, according to Cincinnati Children's Hospital.

If successful, the improved system would reduce the need to get dialysis at hospitals, physician's offices or specialty clinics.

That could save costs and could sharply improve satisfaction for patients, who often commute as much as three times a week to a dialysis treatment center for four-hour sessions.

Bissler has been working more than a decade and holds more than a dozen patents on a system he calls an "intelligent continuous venovenous hemofiltration system."

"This technology represents a major leap forward in the area of home care, and an opportunity for these patients to lead more normal lives," Bissler said.

The system works by precisely tracking fluid extraction rates from the patient's blood and automatically compensating for low blood pressure and other factors that can affect the process.

Some dialysis devices already are available for home use, but their popularity has been limited because most machines require frequent adjustments by trained staff and extensive training for the patient or caregiver.

BTG's role will be to move the system from an experimental device into a marketable product.

"We are looking forward to working with Cincinnati Children's in commercializing this technology, which will have such an important influence on the care of many patients," said Anthony Lando, BTG's chief operating officer.

BTG, formerly known as British Technology Group, is based in London with U.S. headquarters in Philadelphia.

The company has helped commercialize many innovations, including advances in Magnetic Resonance Imaging systems.

For Cincinnati Children's, the dialysis deal could be a major financial boon.

In the past five years, the hospital's licensing revenues have grown from $330,000 a year to $1.2 million a year, primarily from sales of genetically engineered mice and monoclonal antibodies.

In addition to the dialysis system, the hospital is hoping for big returns from two other products, Fondacaro said.

A rotavirus vaccine could be ready to market within two years, and surfactant, a substance that helps lungs function in premature infants, remains three to four years from market.

E-mail tbonfield@enquirer.com

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