RenalTech International Presents New Technology to Improve Dialysis at BIO '99 Conference.
RenalTech's polymer technology enhances removal of a class of blood toxins known as middle molecular weight toxins. Recent research has demonstrated a correlation between these toxins and patient mortality, as well as specific effects of these toxins, including destructive arthritis and carpal tunnel syndrome, immune system inhibition, and susceptibility to infection and chronic malnutrition.
"Dialysis patients constantly suffer from side effects or morbidity due to the inability of the current dialysis procedure to effectively remove middle molecular weight toxins. These toxins can cause severe health conditions and may be one of the causes of premature death in dialysis patients," said Andrew Braverman, RenalTech President, who, with his executive team, presented the technology at the BIO meeting. "New studies have shown the substantial health benefits to dialysis patients when even a small amount of these toxins are removed."
BIO'99 showcases biotechnology's progress and the industry's leading companies. RenalTech was among 36 companies selected to present. An estimated 5,000 attendees from 40 nations were expected at this year's exhibition.
Dialysis and middle molecular weight toxins
Current hemodialysis technology purifies blood by efficiently removing small molecules, such as salts and urea, as well as excess water. However, as toxic molecules increase in size, the ability to remove them utilizing standard dialysis procedures is sharply reduced. Only 10% to 40% of these larger molecules, called middle molecular weight molecules, are removed during a typical dialysis session.
RenalTech's polymer technology
RenalTech chemists have designed technologically advanced polymeric adsorbents to remove toxins from human blood in conjunction with the dialysis procedure. RenalTech's proprietary polymer has eliminated up to 98% of the middle molecular toxin beta-2 microglobulin during simulated four-hour in vitro hemoperfusion experiments.
The polymer has also been tested against many other middle molecular weight toxins. Removal rates for each of these toxins in simulated in vitro hemoperfusion sessions are 86% or greater. RenalTech scientists note that in vivo removal rates for beta-2 microglobulin and other toxins are unknown. Human clinical studies of the removal rate of beta-2 microglobulin are anticipated to begin later this year.
The RenalTech device will be marketed as a complement to current dialysis systems. RenalTech anticipates filing a 510(k) application with the FDA in the fourth quarter, and currently is working with one of the world's leading polymer manufacturers to prepare for large-scale manufacturing of its adsorbent polymer.
Chronic kidney failure
Last year, in the United States, approximately 225,000 patients required hemodialysis an average of three times per week. The dialysis patient population is growing at a rate of 6%-7% annually, driven in part by increased incidence of diabetes and hypertension, which ultimately can lead to kidney failure.
When kidneys fail, there are two options: transplantation or a form of dialysis -- usually hemodialysis. Hemodialysis removes toxic waste products and excess fluids from the blood extracorporeally, with the blood flowing outside the body through plastic tubes connected to a specially designed filter known as a dialyzer.
With over 40 million dialysis sessions performed last year, RenalTech believes that if its polymer cartridge demonstrates significant improvement in outcome for these patients, it will be appropriate for use in all individual hemodialysis sessions.
Based in New York City, RenalTech International was founded in 1997 to identify and develop medical applications for its proprietary adsorbent polymer technology. RenalTech initially is focusing on applying its innovative technologies to improve the quality of life and extend the life span of over 800,000 chronic renal (kidney) failure patients worldwide.
Earlier this year, RenalTech was selected to present at the Alley to the Valley conference co-sponsored by the New York City Economic Development Corporation featuring the city's most promising high-technology companies.