Xcorporeal, Inc.
(Amex: XCR) is a medical device company developing an innovative extra-corporeal platform technology that may be used in devices to replace the function of various human organs. The platform will lead to three initial products; a device for home hemodialysis, another device for hospital Renal Replacement Therapy (RRT) and the Wearable Artificial Kidney (WAK) for continuous ambulatory hemodialysis. These devices will seek to provide patients with improved, efficient and cost effective therapy. The RRT markets represent multibillion dollar opportunities.
For the RRT market, Xcorporeal is developing a portable, multifunctional renal replacement device that will offer cost effective therapy for those patients suffering from Acute Renal Failure (ARF) which causes a rapid decline in kidney function. In the U.S., the disease affects more than 200,000 patients annually, with a mortality rate of 50%. The Xcorporeal platform technology is a natural fit for the hospital market of renal replacement therapy since the technology is designed to provide cost-effective, continuous therapy. The projected 2007 market opportunity for the U.S. is approximately $1.4 billion. The disposable market is expected to grow at 10% per year. The devices typically need to be replaced every five years. The Company intends to commercialize this device during the first half of 2009.
Xcorporeal also plans to commercialize a home hemodialysis machine and the WAK for the End Stage Renal Disease (ESRD) market, which are patients in which the kidneys cease to function. Xcorporeal's devices will combine the best attributes of currently marketed home hemodialysis machines to create hemodialysis devices which offer patients convenient, durable and truly portable devices for home use. The Company believes its machines will provide a cost-effective alternative to current home treatment modalities, due to their ability to offer hemodialysis without the need for large quantities of dialysate fluid or purified water. The WAK will be a revolutionary device intended to enable patients with ESRD to achieve a quality of life closer to that of healthy individuals.
Patients with chronic kidney failure could be freed from fixed dialysis machines, thanks to a wearable artificial kidney that has shown promising results in a pilot study. British researchers said on Friday the battery powered device, developed by U.S. firm Xcorporeal Inc, had proved successful when worn for periods of 4 to 8 hours. The long-term goal is round-the-clock use, doing away altogether with the need for patients to be hooked up to a fixed haemodialysis machine in a hospital or clinic for 12 hours a week.
“The device has the potential to become a practical means of delivering extended and more frequent dialysis to patients with end-stage kidney failure,” Andrew Davenport of University College London and colleagues wrote in the Lancet medical journal. Further tests are now needed, since their small study involved only eight patients, with an average age of 52 years, who were established on regular haemodialysis before being fitted with the wearable — though rather bulky — device. The rate of blood flow and the speed at which toxic chemicals were removed from the body was considerably slower than in conventional
dialysis but this was not seen as a problem, since the device can be worn for long, continuous periods. Two of the patients experienced blood clotting, due to receiving insufficient anticoagulant medication, and one was temporarily disconnected when a needle became dislodged.
Nonetheless, all the subjects said they would recommend the treatment
to other patients with kidney failure, the researchers reported.
Nearly 1.3 million people worldwide suffer from chronic kidney failure that requires treatment with dialysis. A lucky few receive a kidney transplant but donor organs are scarce. In the long term, experts hope miniaturization and nanotechnology will provide more convenient and, ultimately, implantable devices that replicate the function of a healthy kidney. “The wearable artificial kidney reported today is a small first step in the long road to wearable blood-cleansing devices,” said Garabed Eknoyan of Baylor College of Medicine in Houston, Texas.
PEOPLE with chronic kidney failure face a bleak future. Conventional dialysis cleanses the blood of only about 17% of the toxic chemicals that a healthy kidney removes. And donor organs are scarce. The 300,000 Americans who depend on dialysis to stay alive are crippled by an array of complications caused by the buildup of dangerous poisons in their blood, and only one-third survive more than five years. Experimental devices in development could help turn this situation around. One advance, a battery-powered, wearable dialysis machine, would allow users to have their blood cleansed round the clock instead of being hooked up to machines 12 hours a week, potentially improving quality of life and reducing mortality. Even further ahead, blood-filtering systems created via nanotechnology -- engineering on a scale onebillionth the size of a meter -- may prove more effective than current dialysis and may even lead to miniaturized, implantable artificial organs that mimic the continuous function of healthy kidneys. "There's been an explosion in innovation in dialysis in the past few years," says Dr. Allen Nissenson, director of the Dialysis Program at UCLA's Geffen School of Medicine. "In the not too far future, this new technology could transform the field. . . . If it works, it could improve people's lives by providing a form of dialysis that is much more like what natural kidneys do."Round-the-clock treatment Currently, people suffering from chronic kidney failure must undergo half-day hemodialysis sessions tethered to bulky machines three times a week to have toxic chemicals cleared from their blood. The intensive treatment can be physically and psychologically draining and cause cramps and nausea. Because their kidneys no longer flush out fluids, patients must restrict their fluid intake. They must avoid foods containing potassium and phosphorous, because their bodies can't metabolize them properly. Patients also take a fistful of medications every day to help their tissues absorb the scant amount of these minerals their bodies can manage and to stave off the collateral damage of kidney failure such as heart disease, anemia, high blood pressure, osteoporosis, severe joint pain and loss of mental acuity. "These patients are miserable and not infrequently they tell me, 'I can't take it anymore, stop and let me die in peace,' " says Dr. Victor Gura, a nephrologist at Cedars-Sinai Medical Center who has invented a wearable artificial kidney, and chief scientific officer at Xcorporeal Inc., the L.A.-based company developing his device. Growing scientific evidence suggests that increasing the frequency and duration of dialysis treatments could greatly reduce this suffering. But dialysis is expensive, and there are not enough machines or nurses to give everyone daily treatments. "The exponentially increasing number of patients requiring dialysis -- a population that is growing 10% annually -- coupled with the crisis in heathcare funding in the U.S. is putting immense pressure on us to deliver dialysis in a completely different way," says Dr. William Fissell, a nephrologist at the Cleveland Clinic in Ohio. A wearable artificial kidney would be an important step toward providing
around the clock treatment, says Dr. Claudio Ronco, a nephrologist at St. Bortolo Hospital in Vicenza, Italy, who tested Gura's device in early human trials. "Dialyzing patients continuously with a miniaturized wearable device represents a complete paradigm shiftfrom the way we treat patients today," Ronco says.
How it works
The portable artificial kidney consists of a tiny, double-channeled pulsating pump -- one
circulates blood, the other water -- a fluid-collection bag, a filtration system to cleanse
impurities and disposable cartridges to purify the water so that it can be recirculated.
The device weighs about 10 pounds, uses about 14 ounces of water and is powered by
a 9-volt battery. These components are attached to a belt worn around the waist.
(In contrast, conventional dialysis equipment is the size of a washing machine and
requires 40 gallons of water and 110 volts of electricity, which means it must be
plugged into an electrical outlet.)
"This is an excellent first step," says the Cleveland Clinic's Fissell.
Small pilot studies have been encouraging, the researchers say. Initial tests in May
2006 on six patients in Italy revealed that the device was safe and removed water
effectively without complications.
The results of a more recent trial were reported Nov. 3 at the annual meeting of the
American Society of Nephrology. Eight patients in London wore the belt for as long as
eight hours. The wearable artificial kidney effectively cleansed waste products and
excess fluids from the patients' blood, although at a slower rate than conventional
dialysis. "But if we could use this 24/7 or even 18 hours a day, it would be as good or
better than daily dialysis, and liberate patients from being tied for huge chunks of time
to machines," Gura says. The crude prototype used in these tests was constructed with existing equipment off
the shelf. But now that they've proven the concept works, engineers at Xcorporeal are
fabricating a customized version with turbo-charged pumps and more efficient filters
that would clear toxins and fluids more rapidly, Gura says. They hope to put all the
components together in a streamlined package that weighs about 5 pounds, so that it
can be worn comfortably all day.
"We're still a long way from having an FDA-approved product," Gura says. "But we've
demonstrated this is doable."
