Data from a pilot study of Xcorporeal’s (Los Angeles) Wearable Artificial Kidney (WAK) prototype, which allows patients with end-stage kidney failure to have their blood cleansed around the clock, indicate the dialysis device could be more effective than conventional hemodialysis therapy.

“Every patient on dialysis undergoes blood filtration for nine to 12 hours a week,” Victor Gura, MD, Xcorporeal’s chief scientific and medical officer told Medical Device Daily. “Mortality is high. There is mounting evidence that if you increase the amount of dialysis time you give the patient — not the efficiency or type to dialysis, but the time — you improve outcomes greatly. Everybody should be dialyzing longer and more often.”

The pilot study was conducted by Gura and Andrew Davenport, MD, at the Royal Free and University College Hospital Medical School (London). The data provide preliminary indications on the safety features of the WAK and provide Xcorporeal with the impetus to move forward with larger studies.

The WAK is a battery-powered, wearable dialysis machine that allows users to move about freely instead of being tethered to conventional dialysis machines. The device straps to a belt and is hooked to the bloodstream through a catheter implanted in the patient’s chest. The catheter is tunneled under the skin and exits above the waist.

“We had no complications whatsoever,” Gura said. “Every patient felt very well and there were no side effects.”

End-stage kidney disease is a complete or near-complete failure of the kidneys to function to excrete wastes, concentrate urine, and regulate electrolytes. In the U.S., more than 400,000 people are on long-term dialysis and more than 20,000 have a functioning transplanted kidney. The most common cause of renal failure in the U.S. is diabetes.

Gura, who invented the device, said, “The hope and desire to have a wearable artificial kidney has been around for years, but until now, nobody has been able to develop it. The need for it changed when we started to understand that if we want people to survive, we need to give them daily dialysis. But we don’t have enough dialysis units to provide this much dialysis. A lot of issues prompted me to develop the WAK.”

Xcorporeal is testing the WAK in Europe and will likely commercialize it there first due to more lenient regulatory protocols than in the U.S., Gura said. The FDA will likely require a PMA application with an approximate two-year review process. Despite the initial efforts in Europe, the company forecasts the WAK may be on the market in the U.S. within five years.

As part of the WAK pilot study, eight patients with end-stage kidney failure who were established on regular hemodialysis were fitted with the WAK for four to eight hours. Patients were given unfractionated heparin for anticoagulation, as they would be for standard hemodialysis. There were no significant cardiovascular changes and no adverse changes in serum electrolytes or acid-base balance.

Clotting of the vascular access occurred in two patients when the dose of heparin was decreased and the partial thromboplastin time returned towards the normal reference range in both of these patients, according to the study.

Gura said future trial plans have not yet been developed. “We’re still working with the prototype,” he said. “It’s a little bulkier and heavier, but it will be less and less of a problem. Patients were able to sleep, walk and all patients said they would recommend the device to others who needed it.”

Earlier this year, Xcorporeal and CT Holdings Enterprises (Dallas) executed a definitive merger agreement. In the deal, a reverse triangular merger, Xcorporeal emerged as the surviving entity. (Medical Device Daily, Aug. 14, 2007)

On Nov. 20 and Dec. 13, 2006, Xcorporeal issued shares of its common stock at a price of $7 per share in private placements to about 100 institutional and accredited investors for gross proceeds of about $29.4 million.

CT Holdings formerly operated as a business development firm providing capital and management expertise to start-up ventures.

Four products that Xcorporeal plans to market are a hospital congestive heart failure (CHF) device; a hospital renal replacement device; a portable home hemodialysis device; and the WAK. Xcorporeal plans to commercialize the CHF device in the latter half of 2008 and the renal replacement device in the first half of 2009.

The company’ stock commenced trading on the American Stock Exchange on Dec. 7, under the ticker symbol XCR.

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