SQ Innovation's Lasix® ONYU Now Available for Order Through Major U.S. Pharmaceutical Distributors

Addressing a Leading Cause of Hospitalization in Older Adults with Heart Failure

BURLINGTON, Mass., Feb. 9, 2026 /PRNewswire/ -- SQ Innovation, Inc. today announced that following its FDA approval in October 2025, Lasix® ONYU (furosemide injection) is now available for ordering through Cardinal Health's Specialty Pharmaceutical Distribution (SPD) and Cencora's Specialty Distribution (formerly AmerisourceBergen).

SQ Innovation also announced that it signed a Medicaid National Drug Rebate Agreement (NDRA) with CMS and that Lasix ONYU is available to 340B-eligible hospitals, medical facilities and pharmacies.

Lasix ONYU received FDA approval on October 7, 2025, for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. The product enables selected patients to receive treatment at home, as prescribed by a clinician, without the need for a healthcare professional to administer the drug.

"We are pleased to announce that Lasix ONYU is now available for ordering through our leading U.S. distribution partners," said Pieter Muntendam, MD, founder, President and CEO of SQ Innovation. "By ensuring broad availability through Cardinal Health and Cencora at a cost-effective price point, we are eliminating two of the most significant barriers to making the home the preferred setting of care for selected patients with worsening heart failure due to fluid overload. With distribution now in place, we can focus our efforts on partnering with the clinical community to develop evidence-based care pathways and support tools for at-home treatment of appropriate patients."

Ordering Information

Ordering information can be found at www.lasix-onyu.com/order.

About Lasix ONYU

Lasix® ONYU is a drug-device combination that was approved by the U.S. Food and Drug Administration on October 7, 2025, for the treatment of edema in adult patients with chronic heart failure. The pharmaceutical component of Lasix ONYU is a novel, high-concentration formulation of the diuretic furosemide, at 30 mg/mL. It comes in a pre-filled glass cartridge containing 80 mg of furosemide in 2.67 mL.  The Lasix ONYU Infusor consists of two main parts: the Reusable Unit and the Disposable Unit. The Reusable Unit is an electromechanical device that contains the battery, motor, and electronic components necessary for operation and safety functions. It can be used up to 48 times before it can be recycled. The Disposable Unit is a sterile, single-use plastic component that holds the drug cartridge. It includes a micropiston pump, fluid path, needle insertion and retraction mechanism, and a 29-gauge needle. After placement on the abdomen, the needle penetrates the skin when the device is activated. The Lasix ONYU Infusor slowly administers 80 mg furosemide over a period of five hours. This method results in significant diuresis similar to IV, but in a more controlled manner. This avoids the brief, intense diuretic effect that occurs with rapid IV infusion or injection. The advanced two component design offers benefits for patients, healthcare providers, payers, and the environment.  For Important Safety Information, Prescribing Information and Instructions for Use, visit www.lasix-onyu.com.

INDICATION

Lasix® ONYU is a loop diuretic indicated for the treatment of edema in adult patients with chronic heart failure.

IMPORTANT SAFETY INFORMATION

Before using Lasix® ONYU, read the Instructions for Use and tell your healthcare provider about all your medical conditions, including if you are allergic to furosemide or any of the ingredients in Lasix ONYU, have trouble urinating, or if you are allergic to medical adhesives.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines.

Warning: Only use the Lasix ONYU Prefilled Cartridge with the Lasix ONYU Infusor. Do not use insulin cartridges or other medicine cartridges in the Lasix ONYU Infusor. Doing so could cause severe injury.

What are the possible side effects of Lasix ONYU?

Dehydration: Lasix ONYU is a diuretic that can make you lose a lot of fluid and with it electrolytes. You may get a dry mouth, have increased thirst, get muscle pains or cramps, have reduced urine output or your urine may be more yellow than normal, you may get a headache, get dry skin, or have nausea or vomiting. Your healthcare provider may check your electrolytes while receiving Lasix ONYU.

Low Blood Pressure: Lasix ONYU may lower your blood pressure temporarily. You may feel lightheaded or dizzy.  This usually happens when you stand. Getting up slowly may help.

High Blood Sugar:  Lasix ONYU may increase blood sugar (glucose) levels if you have diabetes mellitus.

Loss of Hearing: Lasix ONYU can cause ringing in your ears. If so, tell your healthcare provider.

Risk of Sunburn: Your skin may be more sensitive to sunlight while taking Lasix ONYU.

Infusion Site Reactions: Lasix ONYU can cause infusion site pain, bruising and temporary swelling or redness at the site of the Infusor.

Incomplete Dosing:  Make sure the Infusor does not get wet during use.  Also limit your physical activities. Some movements or when it gets wet may stop the infusion and you may not get all the medication.

These are not all the possible side effects of Lasix ONYU. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see the full Prescribing Information and Instructions for Use.

About SQ Innovation

SQ Innovation, Inc. is a privately held Swiss biopharmaceutical company with offices in Zug, Switzerland, Burlington, MA, USA, and Rotterdam, The Netherlands. The company was founded to develop and commercialize innovative, cost-effective therapies for subcutaneous delivery, enabling at-home treatment for conditions that are usually managed during hospitalizations. SQ Innovation has developed a novel drug-device combination for treating edema in adult patients with chronic heart failure — a condition typically requiring intravenous administration of diuretics in a hospital setting.  Lasix ONYU was developed with consideration for patients, payors, healthcare providers, and environmental impact.  Lasix ONYU received approval from the US Food and Drug Administration on October 7, 2025. For more information about Lasix ONYU, including important safety information and the full prescribing information, please visit www.lasix-onyu.com.

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SOURCE SQ Innovation