The Role of the Kidney
The kidneys play a crucial role in fluid balance, the elimination of toxins int he blood, and the balance of several chemical elements in the human body.
Kidney disease is now reaching epidemic proportions. The three highest causes/risk factors of kidney disease are diabetes due to obesity, high blood pressure, and cardiovascular disease. Dialysis is used when the kidney can no longer function adequately.
Currently, dialysis is typically performed three times a week in a clinic or hospital for four to six hours each visit. This intermittency results in these issues between sessions:
Body fluid volume increase
Waste (toxin) accumulation
Electrolyte imbalance (e.g. sodium, potassium)
Between dialysis treatments patients feel lethargic, nauseous, and generally poor because waste, fluids, and electrolytes accumulate between treatments and upset normal body function.
What is a Wearable Artificial Kidney?
GFR90 is commercializing a wearable artificial kidney which will continuously perform the function of the kidney. Essentially, this is an ambulatory dialysis device worn like a vest in it's current iteration which corrects fluid volume levels to closer to normal levels continuously as it is worn, like a healthy kidney would. Reducing fluid volume and toxin levels will lead to improved quality and length of life.
The leading cause of death of dialyzed patients is heart failure from fluid overload. This is a result of the intermittency of in-clinic or hospital dialysis. Most patients are dialyzed three times a week for around five hours for a total of only 15 hours of dialysis a week. Yet a healthy kidney works continuously - 168 hours a week. This intermittency creates fluid overload which puts too much strain on the heart along with other social, medical, and economic issues.
The solution is simple: continuous or near-continuous dialysis which mimics the work of healthy kidneys by reducing fluid. So, we have developed an ambulatory dialyzer which allows a patient to be dialyzed as they move about. This means that the patient can be dialyzing while attending a ball game, driving their car, or relaxing in the backyard.
Our wearable artificial kidney removes fluid (and with it some toxins) which is the key function of a kidney. We anticipate that we can reduce fluid levels to near normal in addition to reducing in-clinic dialysis visits.
Where are we in Development?
Over the past eight years the development team has created several iterations of the wearable artificial kidney with each version carefully validated and tested with over 100 bench tests and over 40 of those with human blood.
We have two trials with humans completed which successfully removed fluid. This proved that the concept works - we can reduce fluid and after a modification with the associated tests and validations, we will continue to move toward a total of 40 human trials. We hope to be able to complete this first human trial phase by late fall 2023.
Do we have Intellectual Property Protection?
We have issued Canadian patent with all 66 claims approved. We have US patent pending and are in the process to submitting European Union patents.
What Else Remains to Be Done?
There are several steps to bringing a world-class medical device to market. We are addressing these steps as we move further along this path:
Further Intellectual Property