SQ Innovation, Inc., a privately held Swiss biopharmaceutical company, announced that its drug-device combination, Lasix® ONYU (furosemide injection), received U.S. Food and Drug Administration (FDA) approval for the treatment of edema (fluid overload) in adult patients with chronic heart failure.

This approval is set to transform the management of a condition that is a leading cause of hospitalization for the elderly, affecting approximately 6.7 million Americans with projections of rising prevalence. Lasix ONYU was specifically developed to enable the subcutaneous infusion of the diuretic furosemide in a home setting for selected patients, allowing administration without the presence of a healthcare professional as typically required for intravenous (IV) delivery.

The product itself is an innovative two-component system combining a novel, high-concentration furosemide formulation (30 mg/mL) with a state-of-the-art small Infusor. The device features a reusable unit capable of up to 48 treatments and a sterile, single-use disposable unit that holds the drug cartridge and pump mechanism. This two-part design reduces manufacturing complexity and cost, allowing the product to be offered at a more favorable price point, which is expected to facilitate widespread adoption. Clinically, Lasix ONYU demonstrated complete bioavailability (112%) in studies, resulting in diuresis and natriuresis similar to IV bolus administration. However, the Infusor's design delivers the 80 mg dose over a five-hour period, which results in a tempered diuretic response that avoids the intense, rapid effect seen with traditional IV methods.

Experts, including SQ Innovation CEO Dr. Pieter Muntendam and Dr. Javed Butler, Professor of Medicine, emphasized the transformative potential of treating worsening heart failure patients at home, which provides significant benefits to patients, health systems, and payors by offering a cost-effective alternative to costly, resource-intensive hospitalizations. S. Craig Thomas of the American Association of Heart Failure Nurses noted that this accessible and affordable option allows for a fundamental shift in clinical care delivery, enabling patients who would normally require several days of inpatient IV treatment to remain home with remote or periodic monitoring. With the FDA approval secured, SQ Innovation plans to launch Lasix ONYU with leading health systems in the fourth quarter of 2025, making it available through pharmaceutical distributors at participating medical facilities and affiliated retail pharmacies.