Patients self-administered a hospital-equivalent diuretic treatment resulting in a reduction of approximately 4 inpatient days per episode, according to study published in the Journal of the American College of Cardiology.

BURLINGTON, Mass., Oct. 14, 2026 /PRNewswire/ — SQ Innovation today announced that results of the SUBCUT HF II trial of its product Lasix^® ONYU have been published in the Journal of the American College of Cardiology (JACC)¹, one of the leading peer-reviewed journals in cardiovascular medicine. The study reported that patients were able to treat themselves at home with a diuretic regimen administered subcutaneously, similar to what they may receive intravenously in a hospital. The study met its primary endpoint of reducing inpatient days. The topline result of the trial had been presented in the Hottest Trials session at Heart Failure 2026, the annual congress of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC), held in Barcelona, Spain in May 2026.

SUBCUT HF II is a multicenter, open-label, randomized controlled investigator-sponsored clinical trial that compared at-home treatment with Lasix ONYU to conventional inpatient treatment with IV diuretics. The trial enrolled 172 patients, aged 34 to 92, who were hospitalized with heart failure and required IV diuretic treatment, across 20 National Health Service (NHS) hospitals in the U.K. Patients were randomized 1:1 to either self-treatment at home using subcutaneous furosemide delivered via a wearable abdominal pump (Lasix^® ONYU), or continued inpatient treatment using IV furosemide.

“The conclusion that a diuretic treatment at home can replace conventional IV treatment in a hospital rest on two pillars: demonstrating that it can induce equivalent diuresis and that patients can safely self-administer a hospital-equivalent dose at home,” said Pieter Muntendam, MD, Founder, President and CEO of SQ Innovation. “Previous studies conclusively reported the former, and this study provides evidence for the latter. Patients self-administered approximately 900 mg of furosemide over the course of treatment — comparable to what a patient may receive during a hospital admission — with similar treatment outcomes.”

“Heart failure affects close to one in four Americans over their lifetime and is one of the leading causes of hospital admissions in the U.S. and around the world,” said G. Michael Felker, MD, MHS, FACC, FAHA, FHFSA, Professor of Medicine, Division of Cardiology at Duke University School of Medicine. “As we have succeeded in doing for countless other medical conditions, we need to develop the tools and learn how to treat these patients in the comfort of their homes, reducing the burden on the healthcare system. This study illustrates how patients can self-administer a course of diuretic treatment comparable to what they may receive in a hospital.”

The trial was co-sponsored by the University of Glasgow and the National Health Service Greater Glasgow and Clyde Health Board and led by Principal Investigators Dr. Ross T. Campbell and Professor Mark C. Petrie of the Glasgow Cardiovascular Research Centre, University of Glasgow. The trial was conducted under the governance of the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). Funding for the trial, including supply of the investigational medicinal product and device, was provided by an investigator-initiated grant from SQ Innovation Inc. SQ Innovation had no role in the trial design, conduct, data analysis, or interpretation.

Publication of the SUBCUT HF II study follows reporting of the results of the Gator SCALES-WHF study on October 11, 2026. This study is a prospective, open-label, single-arm, real-world study conducted at the University of Florida in Gainesville, Florida. This study demonstrated 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. The interim trial results were presented at the Heart Failure Society of America Annual Scientific Meeting 2026 held in Phoenix, AZ October 9-12, 2026.

Edema, or fluid overload, is a common complication of worsening heart failure in older adults. Oral diuretics such as furosemide are commonly used to prevent fluid build-up; however, some patients require a brief course of more intensive IV treatment to remove marked excess fluid, which typically requires hospitalization.

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.

About SUBCUT HF II

SUBCUT HF II (ClinicalTrials.gov: NCT05419115) is a multicenter, prospective, open-label, parallel-group, active comparator, phase II randomized controlled trial evaluating the safety and efficacy of an early supported discharge strategy using a novel subcutaneous formulation of furosemide in patients hospitalized due to heart failure. In the study, 92 patients were assigned to early discharge and 80 to usual care. The study met its primary endpoint. The early discharge strategy resulted in 4.0 more days alive and out of hospital (DAOH) at 30 days (95% CI, 2.1–5.8; P<0.001) and 4.2 more DAOH at 60 days (95% CI, 0.9–7.4), with index hospitalization shortened by an average of 5.5 days (95% CI, 3.6–7.4; P<0.001). Rehospitalizations for any cause at 60 days were 23.9% and 17.5% for the at-home treatment vs usual care, respectively (p=0.33). Serious adverse events occurred at similar rates between groups (25% vs. 23%), and device-related issues occurred in 3% of minipump placements, none of which were serious. Full details of the trial design have previously been published in the European Journal of Heart Failure (doi: 10.1093/ejhf/xuaf018). Full trial results are now published in the Journal of the American College of Cardiology (https://www.jacc.org/doi/epdf/10.1016/j.jacc.2026.07.047).

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.

For Media Inquiries:

pr-media@sqinnovation.com
Ryan Jaslow; ryan@jaslowhealthcomms.com

¹ Campbell, R, Osmanska, J, Docherty, K. et al. Early Discharge Strategy Including Subcutaneous Furosemide in Hospitalized Heart Failure. JACC. 2026 Oct, 88 (15) 1781–1793.
https://doi.org/10.1016/j.jacc.2026.07.047

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SOURCE SQ Innovation