Lowell Therapeutics (LTX) today announced that the FDA has granted Breakthrough Device Designation for Niyad. Niyad provides anticoagulation for patients in the ICU on an artificial kidney machine. When commercialized, Niyad will be the only FDA-approved regional anticoagulant and 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.
The FDA grants Breakthrough Designation to devices that show improved efficacy for the treatment of life-threatening conditions. Breakthrough Designation has many benefits such as expedited review by FDA and it allows for CMS reimbursement of up to 65% of the cost over the exiting 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.