WAK™- History

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Over a decade of work and at a cost of over $30 million the Wearable Artificial Kidney was developed for the treatment of kidney disease. The device, which has been clinically tested in Europe, improves outcomes and has the potential to dramatically reduce treatment costs of this very expensive medical condition.

The WAK™ is a miniaturized dialysis machine that weighs less than 10 lbs., operates on 9-volt batteries and uses less than 400 ml of fluid. In contrast, currently used dialysis machines weigh about 300 lbs., require a connection to a 110volt wall outlet and use 120 liters of water to treat patients. The WAK™ can be ergonomically adapted to the patient’s body contour and be worn 24 hours a day, seven days a week. By allowing for continuous use, the WAK™ provides patients with a much more effective and natural way of removing excess fluids, salt and toxins from the body than current dialysis devices that only treat patients intermittently.

The key characteristic of the WAK™ platform is its pulsating, dual-chambered pump, which allows it to be a fraction of the size and exponentially more efficient than conventional equipment. Conventional pumps have only a compressible elastic tube that generates slow, low amplitude propulsion blood flow. By contrast, the WAK™ generates a pulsating flow of both blood and dialysate. As blood passes through the hollow fibers that comprise the filter, it is treated via a transfer of patented chemicals while waste or excess fluids are removed through a membranous semi-permeable wall of the hollow fibers.

By introducing pulsation into the dialysis process intermittent high pressure is created which generates superior rates of mass transfer and improved clearances. Additionally, the pulses generated in one chamber of the fluid circuit offset the other chamber’s pulses, creating a “push-pull” flow through the membrane filter that further contributes to increased efficiency.

The WAK™ connects to a patient’s blood stream through a proprietary catheter that can be implanted during a 20-minute outpatient surgical procedure using local anesthesia. The process is intended to be simpler, safer and less expensive than the one needed to implant blood shunts typically required of dialysis patients. Continuous blood flow through the device and the observance of a strict aseptic technique using WAK™ patented method are expected to minimize opportunities for bacterial penetration.

End Stage Renal Disease

There are more than 2 million patients suffering from ESRD globally with more than 570,000 in the U.S. The ESRD patient numbers continue to grow steadily at 8% annually worldwide – most of this growth is attributed to an aging population and increasing obesity, diabetes and hypertension. Internationally, the condition is increasingly prevalent in Asian and Latin American countries due to genetic predisposition as well as increasing adoption of Westernized dietary habits.

Since there is currently no cure for renal failure (with the exception of a kidney transplant), treatment focuses on controlling the symptoms, minimizing complications and slowing the progression of the disease. Typical avenues of treatment include: addressing blood sugar and blood pressure issues with medication, implementing dietary changes to reduce potassium, phosphorus, sodium and protein and restricting fluid intake to minimize the work required of the kidneys. However, over time kidney damage will advance until function essentially ceases. At this point, the patient is diagnosed as having ESRD and will require either a kidney transplant or dialysis to stay alive. Approximately 17,000 kidney transplants took place in the U.S. last year, which translates to less than 3% of Dialysis patients in the US.

Lecture given by Dr. Victor Gura, inventor of the WAK

CLINICAL BENEFITS OF DAILY DIALYSIS AND THE WAK™

  • Daily dialysis normalizes the blood pressure of Dialysis patients, eliminating or greatly reducing the need for blood pressure medications. We believe that Normal blood pressure achieved by daily dialysis or continuous dialysis with the WAK™ would also greatly reduce the incidence of strokes and heart attacks that Dialysis patients currently experience. These incidents often require hospitalization and can be fatal.
  • Patients with kidney failure do not eliminate excess water from their bodies, since they produce little or no urine. The retained fluid accumulates in the lungs, resulting in severe breathing problems. As fluid that accumulated over two or three days must be removed bluntly over three or four hours, this fast, unnatural removal causes great discomfort and increases the risk of strokes and heart disease.Fluid overload is one of the main causes of hospitalizations in this population. Daily dialysis has been shown to eliminate this problem, and we believe that use of the WAK™ would also eliminate this problem.
  • Patients with kidney failure retain large amounts of phosphorus, which results in severe bone disease. In order to control this problem, patients receiving dialysis three times per week have to swallow 12 to 15 pills a day in order to remove the excess phosphorus through the gut. In daily dialysis, excess phosphorus is removed without the need for any pills. The WAK™ has been shown in animal and human studies to remove the same amount of phosphorus as in daily dialysis. We also believe that continuous dialysis using the WAK™ would not only eliminate the patient’s need to swallow 12 to 15 pills a day (and save associated expenses), but would also greatly reduce the incidence of bone disease in these patients.
  • Shunts (connections between an artery and a vein) used in conventional dialysis, often clot or become infected. This results in the need for repeated surgical interventions and hospitalizations. Repeated and more frequent needle insertions with daily dialysis have already resulted in increased need for surgical procedures. The WAK™ is connected to a vein via a specially designed catheter, in a less complex outpatient surgical procedure. The WAK™ blood connection is expected to greatly reduce infections incurred by patients and avoid painful repeated needle sticks.
  • ESRD patients dialyzed with conventional dialysis are often malnourished, which results in a greater risk of infection and other complications. Daily dialysis has been shown to eliminate malnutrition in ESRD patients. The WAK™ has been shown in animal and human studies to have the same biochemical effects as daily dialysis and, therefore, it is likely to eliminate malnutrition.
  • Conventional dialysis treatment does not remove enough salt from the body, but daily dialysis does. Accumulation of excess salt in ESRD patients is a common cause of high blood pressure and heart disease. This condition requires imposing severe restrictions on the salt intake of dialysis patients. We believe that the WAK™ would allow patients to ingest salt, making food more palatable.
  • Dialysis patients in rural areas are subject to additional hardship and expense since they often have to travel great distances to get to the nearest dialysis unit. We believe that the WAK™ would reduce the frequency and duration of those trips.
  • ESRD is physically debilitating such that most dialysis patients are permanently disabled and on welfare. Daily dialysis has been shown to rehabilitate these patients and greatly increase their ability to work and exercise.
  • Foods commonly consumed by healthy people become restricted for ESRD patients, further hindering their quality of life. Failure to observe these restrictions can result in serious complications, including bone disease, strokes and heart disease, and sometimes, even death.
  • Unfortunately daily dialysis remains, for the most part, impractical due to operational constraints at dialysis centers. If each patient were to spend more time on dialysis machines every week, additional machines, space and personnel will be needed. Many centers already lack adequate facilities and staff resources at their present levels of utilization, in which patients only receive treatment three times a week.
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    There is little investment incentive to build twice as many units as we have today, and insurance carriers and taxpayers show no desire to pay more for dialysis time. Further, there are not enough nurses and technicians to allow for the delivery of daily dialysis. While home dialysis is a viable alternative to providing more frequent and longer dialysis it only reaches 10% of the ESRD population. We believe that the WAK™ delivers the clinical benefits of daily dialysis as well as enhances patients’ quality of life.