Gator SCALES-WHF, an investigator-sponsored study at the University of Florida, shows effective decongestion of patients at imminent risk for hospital admission with minimal user, device or safety issues; 30-day admission for treatment failure or insufficient response was rare.

BURLINGTON, Mass., Oct. 12, 2026 /PRNewswire/ — SQ Innovation today announced interim results from the Gator SCALES-WHF study of its product Lasix® ONYU, a novel subcutaneous formulation of furosemide for people with heart failure-associated edema. Among 21 patients at imminent risk for hospital admission who started treatment at home on the day of presentation, 86% were successfully decongested at home without hospitalization. Three patients were admitted within 30 days for additional treatment. The results were presented October 11 at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, Arizona.

Gator SCALES-WHF (SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure) is a prospective, open-label, single-arm, real-world study conducted at the University of Florida in Gainesville, Florida. The study is sponsored by the University of Florida and led by Principal Investigator Mustafa M. Ahmed, MD, Division of Cardiovascular Medicine, University of Florida College of Medicine. The interim results were presented by Jude ElSaygh, MD, cardiology fellow at the University of Florida, Gainesville.

“Patients who have failed up-titration of oral diuretics have, until now, had few options other than coming into the hospital for IV therapy,” said Dr. Ahmed. “In Gator SCALES-WHF, we provided subcutaneous treatment at home on the same day to patients whom we considered at imminent risk for admission. These interim results show that a structured at-home pathway can be implemented without delay and can decongest patients effectively and safely and keep them out of the hospital.”

The study evaluates a site-specific clinical pathway for at-home treatment of patients with worsening heart failure who failed oral up-titration and were deemed at imminent risk for hospitalization. The study setup reflects future routine clinical practice with subcutaneous furosemide infusion but imposed some study-related constraints. Eligible adults aged 18 to 80 had congestive heart failure with signs of fluid overload despite oral diuretic up-titration and an expected need for at least three days of parenteral diuretic therapy — patients who would otherwise be at imminent risk for hospital admission. Treatment with Lasix ONYU was initiated the same day, and patients self-administered Lasix ONYU at home, either independently or with the help of a caregiver. Patients were followed for 30 days.

As of the interim analysis, 21 patients had been enrolled and had completed 30-day follow-up. Patients had a mean age of 63.1 years, 38% were women, and 67% had heart failure with reduced ejection fraction. At enrollment, median BNP values were 1,125 pg/mL [IQR, 204–4,300], which is comparable to levels that may be found in patients with heart failure presenting to the emergency room and who are typically admitted for inpatient treatment. 

Participants successfully self-administered a total of 95 doses. User, device or safety issues were minimal, and no patient discontinued for user, device or adverse event-related reasons. 

“The conclusion that a treatment is an alternative to inpatient IV diuretics rests on two pillars: demonstration of diuretic effects similar to IV and demonstration that patients can do this safely in the comfort of their homes,” said Pieter Muntendam, MD, founder, President and CEO of SQ Innovation, the manufacturer of Lasix ONYU. “This study mimics the same-day initiation of therapy in patients at imminent risk for admission that is now possible under the medical benefit for Medicare Part B and other insurers. Use in those at imminent risk for admission provides value to payors and providers, while patients may benefit from avoiding a burdensome hospital stay.”

Edema (fluid overload) is a leading cause of hospitalizations globally for people over 65 years old with heart failure, and typically requires inpatient IV diuretic therapy that can take up to one week. In the U.S., more than 1.2 million people are admitted for heart failure each year, significantly contributing to Medicare and other health insurance expenses amid ongoing hospital overcrowding.

Lasix ONYU is a novel drug-device combination that was approved by the U.S. Food and Drug Administration (FDA) in October 2025 for the treatment of edema in adult patients with chronic heart failure. The Lasix ONYU Infusor slowly administers 80 mg of the diuretic furosemide over a period of five hours, resulting in significant diuresis similar to IV, but in a controlled manner designed for at-home administration to provide a tempered diuretic response.

About Gator SCALES-WHF

Gator SCALES-WHF (ClinicalTrials.gov: NCT06979726) is a prospective, open-label, single-arm study sponsored by the University of Florida. It is designed to develop, implement and evaluate a site-specific clinical pathway for at-home treatment with subcutaneous furosemide (Lasix ONYU) in adults presenting with worsening heart failure and fluid overload despite oral diuretic up-titration. The study follows patients for 30 days after treatment initiation and evaluates patient factors, safety, and device operation under real-world conditions ahead of routine clinical implementation.

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. Lasix ONYU is available for ordering from Cardinal Health and Cencora and for dispensing and overnight delivery from Walmart Specialty Pharmacy. 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 micro-piston pump, fluid path, needle insertion and retraction mechanism, and a 29-gauge needle. After the device is placed on the abdomen and activated, the needle penetrates the skin. The Lasix ONYU Infusor slowly administers 80 mg of 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. Lasix ONYU is a second-generation combination product for subcutaneous furosemide that follows the introduction of Furoscix in 2023. While primarily intended for home use, the drug delivery system may also be prepared and placed in an emergency room, a physician’s office, or a hospital outpatient setting. The advanced two-component design of Lasix ONYU offers benefits for patients, healthcare providers, payors, and the environment. For Important Safety Information, Prescribing Information and Instructions for Use, visit www.lasix-onyu.com.

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 U.S. 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.

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 at www.lasix-onyu.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are, or may be considered, “forward-looking statements.” All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “on track,” “plan,” “potential,” “target,” “will,” or “would,” the negative of terms like these, or other words or terms of similar meaning. These may include implied or express statements about our expectations regarding strategy, business plans, and objectives for Lasix ONYU; coding, coverage, and reimbursement determinations by CMS, Medicare Administrative Contractors, and other third-party payors, including whether Lasix ONYU is added to or kept off any Self-Administered Drug Exclusion List; decisions by regulatory authorities regarding marketing approval or material restrictions, limitations, or obligations on marketing and market access of the Company’s products; delays in arranging satisfactory manufacturing capabilities and establishing commercial infrastructure; the risk that third-party payors (including governmental agencies) will not reimburse for the use of products at acceptable rates or at all; the risk that third parties will not agree to license any necessary intellectual property on reasonable terms or at all; and other risks set forth from time to time. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Lasix® ONYU is the proprietary name for the furosemide injection combination product in the U.S. The trademark Lasix® is registered for Validus Pharmaceuticals L.L.C. in the United States and used by SQ Innovation under license. The proprietary name for Europe has not yet been established. Furoscix is a trademark of MannKind Corporation

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