The Opportunity

Lowell is developing an anticoagulant for critically ill patients in the ICU who experience kidney failure and need to go on an artificial kidney machine called continuous renal replacement therapy (CRRT), which is 24/7 dialysis. This machine involves circulating blood outside the patient through a filter. Eventually blood will clot in the filter unless it is anticoagulated. When the filter clogs, doctors and nurses must stop the machine to change it – throwing away clotted blood and in the process, increasing blood loss and need for transfusions.

It is then time consuming for ICU doctors and nurses to re-establish the dialysis circuit. The ideal product provides anticoagulation in the filter but not in the patient, thus the need for developing a regional (versus systemic) anticoagulant.

Today’s Inefficient Standard of Care

The Kidney Disease Improving Global Outcome (KDIGO) Clinical Practice Guidelines for Acute Kidney Injury recommend using anticoagulation during RRT. However, there is no suitable anticoagulant available – today’s standard of care is inefficient, and not meeting patient and doctor needs.

Citrate

Citrate anticoagulation is used in an off-label fashion but requires advanced training and very frequent blood sampling (every 4 hours) for monitoring to ensure that patients do not develop life-threatening hypocalcemia or alkalosis. When hospitals do use citrate, they can buy the product from compound pharmacies, which means the quality of the product can vary between pharmacies.

Further, citrate requires the use of calcium, which suffers from constant drug shortages.

Heparin

Heparin is used reluctantly in CRRT because of its long half-life (~3 hours in patients with AKI), which results in systemic exposure that can lead to bleeding. Heparin is contraindicated in patients at risk of bleeding since doctors fear over-anticoagulating these patients.

Also, use of heparin can cause heparin resistance or heparin-induced thrombocytopenia (HIT).

Lowell’s Solution

A Potential FDA First

If approved, Niyad™ would be the first and only FDA-approved regional anticoagulant. Niyad™ is a small molecule, short-acting anticoagulant. We anticipate that use of Niyad™ may result in a longer filter lifespan, less blood loss, fewer platelet transfusions, fewer bleeding events, and less downtime. If approved, Niyad™ may be used in patients at risk of bleeding and patients with liver failure, whereas the existing standard of care cannot.

Competitive Advantage

If approved, Niyad™ may fill a need that is not presently addressed by any anticoagulant. Niyad™ would be the first and only regional anticoagulant; “regional” as it provides anticoagulation in the machine, not in the patient. We believe Niyad™ has no contraindications. Niyad™ may result in fewer filter changes, less blood loss, fewer transfusions, more importantly – lower cost of doctor and nursing time (the decision makers in selecting an anticoagulant).

Heparin

We believe NiyadTM will be proven to be safer than heparin because heparin is a systemic anticoagulant and is contraindicated in patients at risk of bleeding (e.g., post-op patients).

Citrate

Citrate is used off-label because no FDA-approved alternative exists. It cannot be used in patients with liver failure. For the use of citrate as an anticoagulant, advanced training and special monitoring steps are required to ensure that patients do not develop life-threatening side effects. NiyadTM is much easier to administer than citrate.

Customers

Intensivists & nephrologists are the patients’ care providers and the decision makers on the choice of anticoagulant for use in RRT procedures. Reimbursement is established for anticoagulation of this patient in the ICU.

Breakthrough Designation allows for the Centers for Medicare and Medicaid Services’ (CMS) to provide reimbursement of up to 65% of the cost over the exiting DRG. This program is designed to increase patient access to breakthrough technologies and encourage adoption of new technology immediately upon commercialization.