Niyad™ is an anticoagulant for patients with sudden kidney failure in the ICU who need to go on an artificial kidney machine for dialysis 24/7, which is called continuous renal replacement therapy, CRRT.
Exposure of blood to the dialysis filter initiates the coagulation cascade and creates blood clots in the filter, which may result in:
More frequent filter changes
Increased blood loss
Delayed/prolonged treatment time
The KDIGO Clinical Practice Guidelines for Acute Kidney Injury recommend using anticoagulation during CRRT. However, the current standard of care is simply inadequate.
Niyad™ provides Regional Anticoagulation
Niyad™ may result in fewer filter changes, less blood loss, fewer patient transfusions, more importantly – lower cost of doctor and nursing time.
These factors led to the FDA granting Breakthrough Device Designation for Niyad™.
FDA granted Breakthrough Device Designation for Niyad™
FDA grants Breakthrough Designation to devices that have the potential for improved efficacy in the treatment of a life-threatening condition. Niyad™ provides an option for anticoagulation that does not exist today and is an improvement over the standard of care, especially in patients undergoing CRRT that cannot tolerate heparin or are at a higher risk of bleeding. Breakthrough Designation has many benefits such as expedited review by FDA. But more importantly, it allows for CMS reimbursement of up to 65% of the cost over the existing DRG. The program is designed to encourage adoption of new technology immediately upon commercialization and should greatly enhance the value of both Niyad™ and LTX.
In-Patient and Out-Patient Dialysis
When the kidneys are no longer working effectively, waste products and fluid build-up in the blood. Dialysis takes over a portion of the function of the failing kidneys to remove the fluid and waste. Dialysis is typically needed when approximately 90 percent of the patient’s kidney function is lost. Kidney function can be lost rapidly (acute kidney injury) or over months or years (chronic kidney disease).
Some patients that require dialysis 3x per week due to chronic kidney disease cannot tolerate heparin and may benefit from the use of a regional anticoagulant.
Breakthrough Device Designation provides expedited review by FDA and reimbursement programs designed to encourage adoption of new technology immediately upon commercialization.
Expedited development path due to device designation. FDA confirmed endpoint – clinical study readout and exit expected within 2 years.
The World Wide market for NiyadTM is $1.6 billion with peak sales of $305 million in the US.